Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

MADISON, Wis.–(BUSINESS WIRE)–#Biomarker–Promega Corporation intends to seek US Food and Drug Administration
approval and CE-IVD marking for a commercially available Microsatellite
Instability (MSI) assay to assist oncologists and pathologists in
determining colorectal cancer decisions. MSI status is a measure of
mismatch repair deficiency commonly found in solid tumors. In addition
to the colorectal cancer intended use, Promega intends to investigate
additional possible applications for the MSI Diagnostic Test.

The current Promega Research Use Only MSI Assay has been available and
used in the market as part of Lab-Developed Tests since 2004. This
patent protected technology is considered the gold standard molecular
assay for detecting DNA mismatch repair deficiency. An FDA cleared
Promega In Vitro Diagnostic version of this kit will extend the benefits
of MSI detection to the specific needs of clinical labs. The MSI assay
is reimbursable, has a fast turn-around time and most importantly there
is a large body of evidence supporting use of MSI in colorectal cancer

“The impact of having an MSI result on patient outcomes is becoming
clearer each day,” says Randall Dimond, PhD, Chief Technical Officer at
Promega. “Having a reliable, inexpensive functional assay with quick
turnaround like MSI accessible to every pathology lab offers physicians
a vital tool with which to make strategic decisions.”

In clinical research, MSI is a biomarker that is proving to be
increasingly important in understanding the most effective treatment
methods for various types of cancers. MSI detection has captured the
interest of researchers looking at DNA damage in many areas due to its
reliability, simplicity and low cost.

Recently the
FDA announced fast-track approval of the Merck drug Keytruda
on MSI status for all advanced solid tumors. Leveraging this news,
Promega is expanding its network of clinical researchers to better
understand these new applications for MSI status in solid tumor types
beyond colorectal cancer.

“Following recent specific discussions with a number of labs, it is
clear that they view the Promega MSI assay as an important tool for
determining DNA mismatch repair deficiency that is a more
straightforward measurement relative to next-generation sequencing,”
says Heather Baird Tomlinson, PhD, Business Unit Leader – Molecular
Diagnostics at Promega. “Our research showed that large marker panels
and tumor mutation burden as defined by next-generation sequencing are
excellent tools for research, but the impact of the information they
provide is unclear, the assays are too costly, and the turnaround time
is too long to be used routinely in a diagnostic setting in the near
term. We will do everything we can to accelerate the delivery of the MSI
technology for these labs in compliance with appropriate regulatory

Promega will rely on its extensive experience and expertise in designing
fragment analysis and multiplex Polymerase Chain Reaction assays for the
forensic industry to develop additional assays to expand and improve
upon its current MSI product offering over the next several years. One
example is a more sensitive MSI kit that is under development as an
IVD at Promega Shanghai for CFDA approval in China.

To learn more about the current Research Use Only Promega MSI Analysis
system, visit

About Promega

Promega Corporation is a leader in providing innovative solutions and
technical support to the life sciences industry. The company’s 3,500
products enable scientists worldwide to advance their knowledge in
genomics, proteomics, cellular analysis, drug discovery and human
identification. Founded in 1978, the company is headquartered in
Madison, WI, USA with branches in 16 countries and over 50 global
distributors. For more information about Promega, visit


Promega Corporation
Penny Patterson
Sr. Director,
Phone: (608) 274-4330