Biocom Supports California Life Science Companies with Best Practices Guide for Safely Returning to the Workplace

Newly Available Publication Synthesizes Relevant Guidance from Multiple Federal and State Agencies

SAN DIEGO–(BUSINESS WIRE)–#California–Biocom, the association representing the California life science industry, today announced that it has published a guide tailored to life science companies with recommendations on how to safely return to the workplace as stay-at-home restrictions enacted in response to the COVID-19 pandemic are eased. “The Path Forward, Biocom’s Return to Work Guide for California’s Life Science Industry” is designed to assist small- and medium-sized life science companies by providing industry best practices for preparing their facilities to meet new workplace safety guidelines. These are aimed toward preventing the spread of the novel coronavirus and safely bringing employees back into the office, laboratory and manufacturing facilities.

“As we respond to the needs of our members during this unprecedented time, ‘The Path Forward’ provides expert guidance from industry leaders on ways life science companies can responsibly transition back into the workplace,” said Joe Panetta, CEO of Biocom. “While the guide does include comprehensive checklists and technical advice on return-to-work preparations, more importantly it provides recommendations on creating a culture of safety and recognizing our employees’ individual needs as they transition back to the workplace—including access to employee assistance and wellness resources.”

Biocom assembled a task force of California life science industry professionals with expertise in environmental health and safety, human resources, operations and communications to lead this effort of aiding smaller companies through the re-opening process. The guide synthesizes the myriad guidance documents available from state and federal agencies such as the U.S. Occupational Safety and Health Administration (OSHA), Division of Occupational Safety and Health (Cal/OSHA), Centers for Disease Control and Prevention (CDC) and others. It provides a starting point for each company to implement safety measures specific to their employees and processes. The guide is designed to supplement, not replace, any mandated guidance from local governments and other public health agencies and officials.

About Biocom

Biocom is the leader and advocate for California’s life science sector. We work on behalf of more than 1,300 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge STEM education programs, and create robust value-driven purchasing programs.

Founded in 1995 in San Diego, Biocom provides the strongest public voice to research institutions and companies that fuel the local and state-wide economy. Our goal is simple: to help our members produce novel solutions that improve the human condition. In addition to our San Diego headquarters, Biocom operates core offices in Los Angeles and the San Francisco Bay Area, satellite offices in Washington, D.C. and Tokyo, and has a continuous staff presence in Sacramento. Our broad membership benefits apply to biotechnology, pharmaceutical, medical device, genomics and diagnostics companies of all sizes, as well as to research universities and institutes, clinical research organizations, investors and service providers.

For more information on Biocom, please visit our website at www.biocom.org. Connect with us on LinkedIn, Facebook, and Twitter (@BIOCOMCA).

Contacts

Biocom Media Contact:
Carolyn Hawley

Canale Communications

Carolyn@canalecomm.com
619-849-5382

FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer

– Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma –

– Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care –

– Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.”

“The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr. Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. “For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile.”

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under Project Orbis. Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract, infections and fever. These results were published in the New England Journal of Medicine on May 14, 2020.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (866) 422-2377. More information is also available at http://www.Genentech-Access.com.

About the IMbrave150 study

IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable or metastatic HCC who had not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints were IRF-assessed overall response rate (ORR) per RECIST and mRECIST.

About hepatocellular carcinoma

According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2020. Liver cancer incidence has more than tripled since 1980. HCC accounts for approximately 75% of all liver cancer cases in the United States. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B and C) or alcohol consumption, and typically presents at an advanced stage where there are limited treatment options.

About Tecentriq® (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

About Avastin® (bevacizumab)

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).

Tecentriq U.S. Indication

Tecentriq is a prescription medicine used to treat adults with:

A type of liver cancer called hepatocellular carcinoma (HCC).

  • Tecentriq may be used with the medicine bevacizumab when their liver cancer:

    • has spread or cannot be removed by surgery, and
    • they have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

  • Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
  • Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
  • Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucus in stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
  • Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
  • Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
  • Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
  • Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

  • have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
  • are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:

    • A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
    • They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
  • are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in hepatocellular carcinoma with bevacizumab include:

  • high blood pressure
  • feeling tired or weak
  • too much protein in the urine

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.

Avastin is approved for:

Avastin, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Their doctor will stop treatment if any serious side effects occur. Patients should contact their health care team if there are any signs of these side effects.

  • GI perforation. A hole that develops in the stomach or intestine. Symptoms include pain in the abdomen, nausea, vomiting, constipation, or fever
  • Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If a patient has recently coughed up blood or had serious bleeding, they should be sure to tell their doctor
  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion-related reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. The patient’s doctor or nurse will monitor for signs of infusion reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and the heart may become too weak to pump blood to other parts of the body (congestive heart failure). These can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone

Patients should talk to their doctor if they are:

  • Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Pregnant or think they are pregnant. Data have shown that Avastin may harm a woman’s unborn baby. Birth control should be used while patients are on Avastin. If Avastin is stopped, patients should keep using birth control for 6 months before trying to become pregnant
  • Planning to become pregnant. Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
  • Breastfeeding. Breastfeeding while on Avastin may harm the baby, therefore women should not breastfeed during and for 6 months after taking Avastin

Patients should talk with their doctor if they have any questions about their condition or treatment.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:
Courtney Aberbach

(650) 467-6800

Advocacy Contact:

David Cooling

(202) 713-0083

Investor Contacts:

Loren Kalm (650) 225-3217

Karl Mahler 011 41 61 687 8503

Rockland Develops Antibody Proven to Detect SARS-CoV-2 in Patient Samples

LIMERICK, Pa.–(BUSINESS WIRE)–Rockland Immunochemicals Inc. has developed a critical antibody reagent essential to antibody tests used to determine SARS-CoV-2 exposure for patients suspected to have contracted COVID-19. This antibody specifically reacts with the SARS-CoV-2 Nucleocapsid protein present in patient samples and has shown in various independent testing laboratories in the United States, Europe and Asia to be both highly specific and sensitive for SARS-CoV-2. This antibody has proven effective in lateral flow assays (immunochromatography), ELISA, Western blotting, Immunofluorescence microscopy, fluorescence-activated cell sorting, and immunohistochemistry.

Dr. Carl Ascoli, Chief Science Officer for Rockland Immunochemicals Inc. stated that, “This antibody is invaluable for the highly accurate detection of SARS-CoV-2 and subsequently COVID-19 disease in various types of patient samples, including nasal and throat swab extracts and saliva.” Rockland is currently in large scale production of this antibody for deployment in rapid tests that can be manufactured and distributed widely. This antibody configured in a rapid test for COVID-19 acts as the chip inside a computer, it powers the diagnostic test to give the intended result. To that end, Rockland’s Nucleocapsid Protein Antibody has been featured in the journal Nature (May 4). The article details how the Thiel lab (Bern, Switzerland) utilized a synthetic genomics platform to clone SARS-CoV-2 to facilitate the screening of antiviral compounds. Rockland’s Nucleocapsid Antibody was used as the detector for the presence or absence of viral protein synthesis post infection. This study resulted in emergency approval for antiviral medications. “We embrace and welcome this opportunity to help to solve this global problem,” said James Fendrick, Rockland’s Chief Executive Officer. “This project validates efforts and investments that we at Rockland have made in technology that supports production of critical reagents for biologics and research.”

Rockland Immunochemicals Inc. has a long established history of providing critical antibody reagents and related tools for the In Vitro Diagnostic industry as a qualified raw material supplier especially in the area of infectious diseases. We have successfully generated and commercialized antibodies to viral proteins corresponding to SARS Coronavirus, H5N1 influenza, H1N1 Neuraminidase H7N9, Avian Influenza A, Swine H1N1 Neuraminidase and others including viral receptors like ACE2. Many of these antibodies have been used either directly or indirectly for vaccine development, drug discovery and diagnostic detection.

About Rockland

Established in 1962, Rockland Immunochemicals Inc. is a global biotechnology company manufacturing tools for basic, applied, and clinical research in functional genomics, gene therapy, and drug discovery markets. Rockland privately held and operates a manufacturing facility with antibody and protein production capabilities near Philadelphia, Pennsylvania. Global markets are supported through a highly specialized network of key distributors. Our laboratories consist of over 60,000 square feet, producing antibodies and antibody-based tools that are used to help define mechanisms related to cell function and disease. Our reputation is based on attention to detail, customer service, and continuous investment in the tools and technologies required to develop a world-class product line. We understand and appreciate how our products are helping solve significant global problems in life science research. We take great care to validate our products before they reach any research laboratory. Each lot of every product goes through rigorous quality-control testing and multi-assay validation in our own facilities for consistent performance.

Company Name and Product are either registered trademarks or trademarks of Company Name in the United States and/or other countries.

The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

Contacts

Ashley Cush

484.791.3823

Ashley.cush@rockland-inc.com

For more information on Product:

Rockland-inc.com

Quanterix Expands Menu of Ultra-Sensitive Neurology Assays with Simoa® P-Tau181 V2 Kit for Improved Detection and Study of Alzheimer’s Disease

Preliminary research demonstrates the biomarker’s revolutionary potential to empower accessible and scalable blood testing for Alzheimer’s disease; Quanterix to discuss latest findings and how researchers can gain early access to newest Simoa assay during June 3 PPH webinar

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced that it will expand its robust menu of ready-to-use Simoa® kits to include tau phosphorylated at threonine 181 (p-tau181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma. A growing body of research, including work published recently in The Lancet Neurology, suggests that the biomarker could prove critical to predicting Alzheimer’s disease progression and differentiating the disease from other neurodegenerative disorders. Moreover, an ultra-sensitive, blood p-tau181 assay may hold the key to advancing preventative care for the disease in clinics and via homecare sampling through a simple, cost-effective blood-based screening that can deliver an early, objective diagnosis. These findings and details on how researchers can gain early access to Quanterix’ new commercial assay through the Simoa Accelerator Laboratory, will be discussed during an upcoming Powering Precision Health (PPH) Think Tank Webinar taking place at 10 a.m., EDT on June 3, 2020.

“Biomarkers continue to play an invaluable role in understanding how neurological diseases manifest, progress and respond to treatment,” said Kevin Hrusovsky, Chairman, Chief Executive Officer and President, Quanterix. “Building on years of innovation and a proven track record for successfully commercializing ultra-sensitive assays that disrupt markets and drive innovative breakthroughs forward, our p-tau181 version 2 assay kit offers researchers unrivaled visibility and specificity into this revolutionary marker in serum and plasma. The exquisite sensitivity of Simoa uniquely positions us to deliver on the promise of p-tau181 to pave new pathways in Alzheimer’s disease exploration, just as our neurofilament light chain (Nf-L) assay has transformed research for other neurological diseases. In particular, the impact of a high-definition, blood-based Simoa assay that rivals traditional CSF or PET scans could be revolutionary, with material potential for home sampling to enable early detection and development and approval of drug therapies desperately needed to improve outcomes for the millions of people living with Alzheimer’s disease today. This biomarker advance fits perfectly in our vision to transform reactive ‘sick care’ into proactive asymptomatic precision healthcare.”

While deaths associated with other pervasive diseases such as heart disease have declined between 2000 and 2018, Alzheimer’s disease-related deaths have increased by 146 percent, according to the Alzheimer’s Association. Importantly, there is no objective test to diagnose the disorder, leading many physicians to rely solely on subjective cognitive assessments. As a result, many patients are not diagnosed until late in the disease’s progression, after symptoms of cognitive decline, such as memory loss, begin to present. Even then, the disease can often be misdiagnosed for another neurodegenerative condition, such as frontotemporal dementia (FTD).

For years, researchers have studied the utility of biomarkers for understanding, detecting and monitoring Alzheimer’s disease. These efforts have been accelerated in large part by the PPH network, which has grown into a global epicenter for biomarker-enabled innovations to not only detect and treat, but ultimately, prevent disease. Resulting studies demonstrate the vast utility of proteins such as total tau and Nf-L. Researchers, doctors and pharmaceutical companies are now harnessing these biomarkers to see the disease earlier, monitor its progression and inform clinical decision making more effectively, and assess the viability of experimental therapies. Quanterix’ ultra-sensitive immunoassay technology, Simoa, which empowers single- and multi-plex detection of key biomarkers with 1000 times greater sensitivity than competing enzyme-linked immunosorbent assay (ELISA) solutions, is the driving technology behind much of this research. Among the most notable is a 2019 Nature Medicine paper that used Simoa to see signs of Alzheimer’s disease 16 years before symptoms through the high-definition detection of Nf-L. The technology has powered hundreds of similarly peer-reviewed journals over the years that demonstrate the potential for blood-based detection of the disease with equal or greater sensitivity as compared to CSF or PET biomarkers. Collectively, these studies create an influential body of research that advances the preventative care paradigm envisioned by PPH at its inception by supporting the utility of a non-invasive and easily administered blood test to detect Alzheimer’s disease before symptoms.

Today, emerging research suggests that p-tau181 could hold even greater diagnostic promise for Alzheimer’s disease, as it has proven capable of differentiating the condition from other forms of dementia with greater specificity than total tau. Leaders in the field of neurodegenerative disease research, such as the authors of The Lancet Neurology paper Professors Henrik Zetterberg, MD, PhD, and Kaj Blennow, MD, PhD, of the University of Gothenburg, believe blood p-tau181 has the potential to revolutionize Alzheimer’s disease research and patient care in much the same way that serum-based Nf-L has for multiple sclerosis (MS).These concepts further progress PPH’s mission and vision to harness biomarkers for true precision health, with myriad implications that include improving understanding of the condition, enabling earlier diagnosis and intervention, informing more accurate long-term care, identifying clinical trial candidates earlier in the disease cascade and, subsequently, accelerating promising new therapies to market.

The latest installment of the PPH Think Tank series of webinars, entitled “Novel p-tau181 Blood Immunoassay and the Future of Alzheimer’s Disease Research,” will explore the vast opportunities associated with p-tau181 to revolutionize the way we approach disease and administer care. Specifically, the discussion will detail how an innovative immunoassay to measure p-tau181 in blood could accelerate efforts to establish a clinically relevant routine Alzheimer’s disease diagnostic test, and the potential high-definition detection via small volume blood samples creates for homecare precision health. Hrusovsky, together with Professors Zetterberg and Blennow, will break down the findings from the recent paper in The Lancet Neurology and examine how Simoa is powering exploration into uncharted territory as it pertains to Alzheimer’s disease detection, monitoring, treatment and prevention.

“We’re on the cusp of what could be an incredible new era for Alzheimer’s patients and those with a genetic predisposition to the disease,” said Zetterberg. “The ability to see dementia asymptomatically and moreover conclusively distinguish it as Alzheimer’s disease-induced could forever change the face of this condition. P-tau181 shows immense promise in this regard, which is augmented considerably when harnessed by a leader in detection like Quanterix.”

“Early findings from our work with p-tau181 are very encouraging,” said Blennow. “The biomarker is proving to be an exceptional new tool in our arsenal against Alzheimer’s disease. While CSF p-tau181 has been recognized as a highly valuable biomarker in Alzheimer’s disease pathology, the greater clinical benefit will come from our ability to effectively harness the marker in blood. The unprecedented specificity of p-tau181 paired with a highly sensitive technology like Simoa promises to broaden our knowledge of this devastating disease considerably, with monumental implications for patients and caregivers.”

To register for the webinar, click here.

To learn more about how you can take advantage of our early access program for p-tau181 through the Accelerator Lab or pre-order your commercial kits, visit https://www.quanterix.com.

For more about Quanterix’ Simoa® technology, visit https://www.quanterix.com/Simoa-bead-technology.

About Quanterix

Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa®, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://www.quanterix.com.

About Powering Precision Health

Powering Precision Health is the world’s first independent, non-profit organization dedicated to bringing the world’s leading physicians, scientists, innovators, investors and patient advocates together to unveil their latest research on new biomarkers that are revolutionizing precision health. Founded by Kevin Hrusovsky, a widely acclaimed thought leader and visionary in life sciences and personalized medicine, Powering Precision Health is a movement that represents the intersection of new technological capabilities with the latest medical research. It’s rooted in the science of precision medicine, which shows personalized treatments to be an increasingly more effective way to maximize drug efficacy and minimize toxicity. In addition to the impact environmental and lifestyle factors can have on minimizing disease triggers, precision health marks an evolution in the way we approach disease and aims to inspire a full healthcare transformation, from philosophy to approach to outcome. In an industry often plagued by skepticism and marred by false promises, PPH puts science first and brings together stakeholders that span from fundamental research to clinical practice, investors, policy makers, patient advocacy groups, and anyone who embraces the vision of Powering Precision Health. Featuring a distinguished keynote lineup of dignitaries, the Summit unveils groundbreaking approaches to prevention, early diagnosis, and next-generation treatments. Powering Precision Health is supported thanks to the generous contributions of sponsors from a wide range of companies and organizations committed to advancing precision health.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts

Media Contact:
PAN Communications

Staci Didner, (407) 734-7325

quanterix@pancomm.com

Investor Relations Contact:

Stephen Hrusovsky

(774) 278-0496

shrusovsky@quanterix.com

Creatv Announces Positive Results for the LifeTracDx Blood Test in the Detection of Early Stage Cancer in Multiple Solid Tumors

Data to be presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Virtual Meeting

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test for the universal screening of early stage cancer. They will present their initial clinical data showing the ability to identify invasive cancer with 87% accuracy. “We are delighted to present results from a training set of 10 different types of cancers,” said Dr. Cha-Mei Tang, Chief Executive Officer of Creatv. “The data shows that we obtained 85% sensitivity for all cancers (from 79% of patients in Stage I and increasing to 95% of patients in Stage IV), and also shows 100% specificity when tested against healthy normal controls. This represents a significant step towards pan cancer screening by a routine blood draw with high sensitivity and specificity.”

Creatv’s poster, Circulating Stromal Cells as a Blood Based Biomarker for Screening Invasive Solid Tumors, Abstract ID: 3535, highlights the performance of the LifeTracDxTM blood test. In a completely novel concept, the test analyzed the patient’s immune response to the presence of cancer by isolating stromal cells originating from cancer sites that have migrated into the blood stream. Creatv has shown that a particular subtype of circulating stromal cell, named Cancer Associated Macrophage-Like cells (CAMLs), can be used to identify patients with cancer but are absent in healthy persons. CAMLs are phagocytic myeloid cells derived from the patient’s immunological response to active malignancy that have engorged cancer cells, thereby containing cancer protein markers and cancer DNA.

In a large multi-institutional study, 7.5mL of peripheral blood was taken from 308 cancer patients after a diagnosis of invasive malignancy, [stage I (n=76), stage II (n=73), stage III (n=72), stage IV (n=65) and unstaged non-metastatic (n=22)]. Patients were recruited with lung, pancreas, breast, prostate, esophageal, renal cell, hepatocellular, neuroblastoma, melanoma, and others. To compare specificity of the test, blood was also taken from 39 patients with untreated non-malignant conditions (i.e. benign breast masses, lupus, liver cirrhosis, etc.), and from 76 healthy volunteers. CAMLs were 87% accurate at identifying cancer patients when compared to healthy controls or from patients with non-malignant conditions.

These initial findings have now been granted funding from National Cancer Institute/National Institute of Health (NCI/NIH), Department of Defense and NCI/NIH for validation studies in the screening of 1000 breast patients, 1000 lung patients and 300 prostate patients, respectively.

Posters will be available online at https://creatvBIO.com/posters.

About LifeTracDxTM Blood Test

Creatv’s liquid biopsy assays (LifeTracDxTM) are commercialized research use only tests designed for analysis of CAMLs and Circulating Tumor Cells (CTCs) from whole blood. LifeTracDxTM tests are applicable for cancer screening, companion diagnostics, prediction of treatment response including immunotherapy, providing prognosis, delivering purified tumor DNA for sequencing, detecting minimal residual disease and early detection of cancer recurrence. LifeTracDxTM tests are currently being implemented in more than 20 clinical trials spanning from basic research to drug development. Creatv’s publications have shown that LifeTracDxTM can be used in an array of solid cancers as an early predictor of patient response to therapy.

About Creatv

Creatv is a privately-held cancer screening and diagnostic company founded in 2000, featuring expertise in both biodetection and microfabrication. Creatv combined both disciplines to develop the CellSieveTM microfiltration technology platform which enables the separation and identification of all cancer associated cells in the blood.

Website: https://creatvBIO.com

Contacts

Ron Baker

ron@creatvmicrotech.com

Daniel L Adams

dan@creatvmicrotech.com

Inventory Management Solution to Reduce Overhead Costs by 32% for a Pharmaceutical Manufacturing Company | Infiniti’s Latest Success Story Provides Unprecedented Insights

LONDON–(BUSINESS WIRE)–#CompetitiveIntelligence–Infiniti Research, a leading market intelligence solutions provider, has recently announced the completion of their latest success story on inventory management solution. During this engagement, the experts at Infiniti Research helped the client to reduce overhead costs by 32% and achieve huge savings in profit margins.


Although the global pharmaceutical manufacturing market has been experiencing positive growth over these years, the industry is not completely free of challenges. Pharmaceutical manufacturing companies are facing challenges in meeting global quality standards, managing supply chain operations, and adhering to new healthcare reforms. To succeed in the long-run, pharmaceutical manufacturing companies are in the need to reduce costs, increase agility, and improve speed to market. Besides, increasing visibility into the supply chain is becoming imperative for companies in the pharmaceutical manufacturing market to address supply chain challenges and meet the demands of a rapidly evolving marketplace.

Infiniti Research’s team of industry experts and analysts are constantly monitoring the business impact of the COVID-19 crisis across sectors to help organizations prioritize response, mitigate risk, and continuously monitor the economic adversities on their business. Request a FREE proposal here.

The business challenge:

The client is a pharmaceutical manufacturing company based out of Italy. The client’s lack of adequate visibility into the supply chain made it difficult for them to track-and-trace goods. This increased the likelihood of drug shortages for the client. Also, profit margins were under pressure as costs crept up throughout the supply chain network. Besides, the client’s lack of access to timely and accurate data from supply chain parties made it difficult for them to synchronize supply and demand.

In addition, as major drugs were heat sensitive and susceptible to contamination, maintaining a desired low-temperature range was becoming a major concern for the client. Owing to such challenges, the client’s valuable customers denied renewing contract with them. The pharmaceutical manufacturing firm, therefore, wanted to adopt solutions to tackle supply chain challenges and meet the demands of rising population. By partnering with Infiniti Research, the pharmaceutical manufacturing market client also wanted to enhance supply chain management while ensuring safer products for patients.

Want to know how we can help you to survive through these tough times and emerge stronger in the post-coronavirus world? Contact us here.

Business Outcome:

By leveraging our inventory management solution, the client was able to manage supply chain activities in the most efficient way. As recommended by the experts at Infiniti Research, the client invested into SCM software and increased visibility into the supply chain. This also enabled the client to synchronize supply and demand and reduce the likelihood of drug shortages. Besides, by increasing visibility into the supply chain, the client was able to improve communication, collaboration, and coordination with vendors, transportation, and shipping companies.

The experts also recommended the pharmaceutical manufacturing market client to leverage cold chain shipping to transport drugs that are heat sensitive and susceptible to contamination. Besides, by having real-time data on the availability of raw materials and manufacturing delays, the company was able to implement backup plans, such as sourcing materials from a backup supplier to prevent further delays. With more accurate demand predictions, the client was also able to reduce the overhead costs by optimizing warehouse layout, adopting the right automation tools to improve productivity, and implementing a better inventory management system. Within one year, the pharmaceutical manufacturing market client reduced overhead costs by 32% using inventory management solution and achieved huge savings in profit margins.

Wondering how your business can benefit from our inventory management solution? Request more information from our experts.

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. To know more, visit: https://www.infinitiresearch.com/about-us

Contacts

Infiniti Research

Anirban Choudhury

Marketing Manager

US: +1 844 778 0600

UK: +44 203 893 3400

https://www.infinitiresearch.com/contact-us

NOXXON Announces Convocation of the Hybrid Annual General Meeting of Shareholders

BERLIN–(BUSINESS WIRE)–Regulatory News:

NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that due to the coronavirus pandemic the annual general meeting of shareholders of the company (the AGM) will be convened as a hybrid meeting at 10.30 a.m. CEST on June 30, 2020. The chair of the AGM will be physically present at the offices of Freshfields Bruckhaus Deringer LLP, Strawinskylaan 10, 1077 XZ in Amsterdam, the Netherlands, while the management and board members will be provided a remote access to participate.

In light of the public health risks arising from COVID-19 and the restrictive measures implemented in the Netherlands and elsewhere to reduce gatherings of people, the company urges its shareholders not to attend the AGM in person. Shareholders do not need to be present to cast their vote at the AGM on June 30, 2020. Instead, they are advised to give voting instructions by proxy. Further details on proxy voting are given in the Attendance Notice for this AGM available on the company’s website (www.noxxon.com).

The company acknowledges that constraints caused by the COVID-19 pandemic restrict the physical presence of its shareholders at the AGM and thus, to ask questions at the meeting. For this reason, shareholders who decide not to attend the AGM on June 30, 2020 in Amsterdam, the Netherlands, and who wish to submit questions regarding items on the AGM agenda, may submit their questions by email to shareholders@noxxon.com until 10.30 a.m. CEST on Friday, June 26, 2020. The email submitting such question(s) must include name, surname, number of shares held by the shareholder on the Registration Date for the AGM and the agenda item to which the question relates.

The annual accounts 2019 and the report of the board of directors for 2019, the convocation, the agenda and the explanatory notes to the agenda, the instructions and documents for participation and voting at the AGM; and the explanatory notes to agenda item 7 with respect to the partial amendments of the Articles of Association are available on the company’s website (www.noxxon.com). These documents are also available at the company’s offices at Max-Dohrn-Strasse 8-10, 10589 Berlin, Germany, for shareholders and persons entitled to attend the meeting who, upon request, will receive a copy free of charge.

Under Dutch law and the company’s Articles of Association, persons entitled to attend and to vote at the AGM are shareholders of the company (which for the purposes of this notice includes holders of a Dutch law right of usufruct) who (i) were registered as a shareholder in one of administration records of the intermediaries that are (indirectly) participants in Euroclear France on June 2, 2020 (the Registration Date) after all debit and credit entries have been handled as per the Registration Date and (ii) have notified the company by 05.00 p.m. CEST on June 23, 2020 of their attendance in writing or electronically (contact details are available on the company’s website (www.noxxon.com)).

About NOXXON

NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients and further studies are being planned in these indications. In September 2019 the company initiated an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX‑E36 in patients with solid tumors both as a monotherapy and in combination. Further information can be found at: www.noxxon.com

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp

https://www.linkedin.com/company/noxxon-pharma-ag
https://twitter.com/noxxon_pharma

Disclaimer

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.

Contacts

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer

Tel. +49 (0) 30 726247 0

amangasarian@noxxon.com

Trophic Communications
Gretchen Schweitzer or Joanne Tudorica

Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191

schweitzer@trophic.eu

NewCap
Arthur Rouillé

Tel. +33 (0) 1 44 71 00 15

arouille@newcap.fr

Personalis, Inc. Announces New Data to be Presented at ASCO Virtual Scientific Meeting

MENLO PARK, Calif.–(BUSINESS WIRE)–#ASCO–Personalis, Inc., (Nasdaq: PSNL) a leader in advanced genomics for cancer, today announced that the company will present new data in abstracts to be presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting, which will be held May 29-31, 2020.

One abstract showcases data from the ImmunoID NeXT Platform™, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Another abstract highlights data from the Personalis NeXT Dx™ Test, one of the first cancer diagnostic platforms to profile approximately 20,000 genes in both the tumor exome and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few hundred genes. The Personalis NeXT Dx Test includes advanced analytics to provide a diagnostic report on genetic alterations in clinically-important cancer genes, as well as emerging immunotherapy composite biomarkers of medical importance.

Following are details and links to the abstracts that will be presented at the online meeting.

Abstract Number &

Session Title

Title & Presenter

Date

Location

6557

Head and Neck Cancers

Exome scale liquid biopsy characterization of putative neoantigens and genomic biomarkers pre- and post anti-PD-1 therapy in squamous cell carcinoma of the head and neck.
Presenter: Charles Abbott

May 29, 2020

Online

e15583

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Validation of an exome and transcriptome based diagnostic platform enabling clinical cancer therapy selection and emerging composite biomarkers for immunotherapy.
Presenter: Sebastian Saldivar

May 29, 2020

Online

About Personalis, Inc.

Personalis, Inc. is a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. The Personalis ImmunoID NeXT Platform™ is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over a million veteran genomes. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA’88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

Forward-Looking Statements

This press release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the future availability, features or potential uses of the ImmunoID NeXT Platform or NeXT Dx Test and other future events. These forward-looking statements are subject to risks and uncertainties, including those related to the evolution of cancer therapies and market adoption of our services, our expectations regarding future performance, and the COVID-19 pandemic, as well as other risks and uncertainties discussed in Personalis’ filings with the Securities and Exchange Commission (SEC), including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Forms 10-K and 10-Q and subsequent filings and in the documents incorporated by reference therein, all of which may significantly impact our business and operations, the business and operations of our customers, our ability to access capital and the value of our common stock. Except as otherwise required by law, Personalis disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investor Relations Contact for Personalis:
Caroline Corner

investors@personalis.com
415-202-5678

Media Contact for Personalis:
Jennifer Havlek

pr@personalis.com
www.personalis.com
650-752-1300

Mirum Pharmaceuticals to Present at the Jefferies 2020 Healthcare Conference

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced that Chris Peetz, president and chief executive officer at Mirum will present at the virtual Jefferies 2020 Healthcare Conference on June 2, 2020 at 10:00 a.m. Pacific Time/1:00 p.m. Eastern Time.

A live audio webcast and archive of the presentation will be available in the Investors & Media section of the company website at ir.mirumpharma.com.

About Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company’s lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). For more information, visit mirumpharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

Contacts

Investor contact:

Ian Clements, Ph.D.

ir@mirumpharma.com

Media contact:

Erin Murphy

media@mirumpharma.com

Non-invasive oXygen Therapies Delay or Prevent Intubation but Are Believed to Aerosolize Coronavirus by 80% of Global Physicians Treating COVID-19 in Hospitals

34% of COVID-19 treating physicians still believe ventilators are used too rapidly according to their hospital protocols

NEW YORK–(BUSINESS WIRE)–#cornovirus–Week 9 (May 17 to 19) results from Sermo’s COVID-19 Real Time Barometer with 4,193 physicians reveal COVID-19 treatment patterns among frontline physicians. In total, Sermo’s Barometer study includes over 49,000 survey interviews in 31 countries, including the United States, Canada, United Kingdom, France, Brazil, Russia, China, Japan and Australia. Complete data published to date and study methodology can be found here.

Universal medical guidelines on COVID-19 and ventilation strategies have not been written or widely adopted yet. Despite the learning that early intubation was often unnecessary and potentially lethal to patients (with ventilator-related mortality rates documented up to 88%)1, many hospitals still have not changed their protocols. One possible reason is that the overwhelming majority of physicians believe non-invasive oxygen therapies put hospital staff and other patients at risk by aerosolizing the virus.

Initially, physicians treated COVID-19 as they would any other virus-induced pneumonia. Patients quickly developed breathing difficulties, treatment protocols were created on the fly, and rapid intubation was encouraged based on older guidelines. Panicked, governments purchased a surplus of very expensive ventilators and the U.S. president invoked the Defense Production Act to compel automotive companies to manufacture ventilators.

  • This week (week 9) in Sermo’s COVID-19 Real Time Barometer, 72% of all doctors (base= 4193) and 80% of hospital physicians treating COVID-19 (base= 764) believe non-invasive ventilation aerosolizes the virus and increases the risk of infection to themselves, other healthcare professionals and patients.

Non-invasive oxygenation devices are inexpensive and widely available. They include heated high flow oxygen delivered via a face mask or nasal cannulas, sleep apnea machines such as continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP). CPAPs and BiPAPs work via a tube into a face mask, as opposed to invasive ventilation, which includes a tube placed deep in a patient’s throat while they are sedated, posing a much higher risk to the patient.

“At the outset of the pandemic, there were worldwide concerns about a shortage of ventilators. Non-invasive oxygen therapies, like CPAP and BiPAPs were and still are associated with an increased risk of virus transmission, and therefore many hospitals are still moving directly to invasive ventilation. If properly protected, physicians shouldn’t fear using these devices and should absolutely delay ventilation,” said Dr. Mark Rumbak, Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine, University of South Florida.

According to a recent study, non-invasive ventilation techniques were proven to be droplet (not aerosol)-generating procedures, producing droplets of > 10 µm in size. Due to their large mass, most fall onto local surfaces within 1 meter.

Gradually, the medical community began to see marked differences in the pathophysiology of the disease versus other known virus pneumonias, and in patient response. Physicians made a startling observation; many COVID-19 patients had blood oxygen levels so low they should have been either dead, gasping for air, or experiencing racing heartbeats from the lack of oxygen. Eventually, the medical community learned patients could tolerate these lower levels of oxygen.

“Oxygen blood levels have typically driven decisions about breathing support and intubation, but with COVID-19 they might be misleading. Additionally, many physicians are realizing respiratory failure of COVID-19 should be treated differently from routine Acute Respiratory Distress Syndrome (ARDS). It’s imperative to communicate that more patients could receive simpler, noninvasive oxygen support. These strategies should be used in the beginning of breathing difficulties and can even be used for the duration of the illness,” said Dr. Rumbak.

However, many physicians feel ventilators are still being used too quickly by their hospitals.

  • In a May 4 Sermo survey, 47% of COVID-19 treating physicians agreed, “we are currently using ventilators too rapidly on patients and we should delay their use as much as possible trying all forms of oxygen therapy initially.” (N=1100 Covid treaters).

In this study, physicians also disagreed about whether they were seeing typical ARDS or a new phenomenon. In week 9 of the Barometer, the number of physicians believing ventilation was occurring too rapidly dropped to 34%, indicating intubations were being slowed down, but were still significantly “too rapid.”

Recently, several leading medical organizations have recommended delaying intubation and using non-invasive ventilation first. The NIH issued new guidelines advocating a phased approach to breathing support that defers the use of ventilators.

The Shanghai guidelines and The Lancet also recommend a similar approach, however, hospitals around the world are not adopting these strategies universally or quickly enough, and each hospital can decide themselves how to treat COVID-19 respiratory failure.

About the Real Time Barometer

The Real Time Barometer is an observational study of the impact of the COVID-19 outbreak as reported by physicians with firsthand experience of treating COVID-19 patients. Each week, thousands of physicians provide insights on topics regarding the global health crisis. To date, more than 49,000 doctors in 31 countries, including the United States, Canada, United Kingdom, France, Brazil, Russia, China, Japan and Australia have participated in the Barometer.

About Sermo

Sermo is the largest healthcare data collection company and social platform for physicians, reaching 1,3MM healthcare professionals across 150 countries. The platform enables doctors to anonymously talk real-world medicine, review treatment options via our proprietary Drug Ratings platform, collectively solve patient cases, and participate in medical market research. For more information, visit sermo.com.

1.https://jamanetwork.com/journals/jama/fullarticle/2765184?guestAccessKey=906e474e-0b94-4e0e-8eaa-606ddf0224f5

Contacts

Media:

Angela Crawford

201-417-9157

Azito35@gmail.com