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

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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 decisions.

“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 based 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

hey 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 agencies.”

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.



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