Promega Corp, Madison, Wis, intends to seek FDA approval and CE marking for a commercially available microsatellite instability (MSI) assay to assist oncologists and pathologists in making 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 Promega research use only MSI assay has been available and used in the market as part of lab-developed tests since 2004. An FDA-cleared Promega in vitro diagnostic version of the kit will extend the benefits of MSI detection to the specific needs of clinical labs. The MSI assay is reimbursable and has a fast turnaround time.
“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 facilitates understanding of 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.
FDA recently announced fast-track approval for use of the Merck drug Keytruda for all advanced solid tumors, according to their MSI status. 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 of molecular diagnostics at Promega.
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.
For more information, visit Promega.