New clinical markers could give insight on effectiveness of immunotherapy

Foundation Medicine announced new clinical markers to its FoundationOne and FoundationOne Heme products. Using FoundationOne and FoundationOne Heme assays, clinicians can now glean insights from TMB and MSI.

According to the findings reported at the American Society of Clinical Oncology (ASCO), TMB measures the number of DNA mutations per megabase in a tumor sequence. TMB can help to determine the likelihood of response to cancer immunotherapies. High TMB can be a result of defective mismatch repair of DNA, known as MSI-high or MSI-high tumors.

“The ability to accurately measure multiple biomarkers simultaneously, including TMB and MSI, is an important advance for the field of cancer immunotherapy, and one that is unique to Foundation Medicine,” said Thomas George, GI oncology program director at the University of Florida, in the announcement. “Foundation Medicine’s combination of advanced sequencing platforms and highly-specific algorithms gives me access to all relevant genomic biomarkers for my patients at once, helping to save both time and tissue.”

Using this information, Foundation Medicine is able to provide physicians with insights that can help “predict response to immunotherapies, identify targeted therapeutic options, and improve access to clinical trials all from a single assay,” the company explained in the announcement.

Vincent Miller, the chief medical officer at Foundation Medicine, noted how crucial cancer immunotherapies are for cancer treatment. He also noted how “quantitative approaches” are important when working with cancer immunotherapies.

“Prior to our ability to measure TMB and MSI with FoundationOne, these biomarkers could only be detected separately, either through tests such as immunohistochemistry, polymerase chain reaction (PCR) or whole exome sequencing,” Miller said in the announcement. “Importantly, high-quality, predictive TMB scoring can only be accurately performed with sophisticated algorithms developed to work with broad, hybrid capture-based platforms that can analyze all relevant alterations simultaneously. Integrating this capability to measure TMB and MSI with one tissue sample, and reported in one test, represents an important advance in clinical care.”

Miller described the findings presented at ASCO as encouraging.  “Our goal is to empower doctors and patients with a full range of relevant, actionable genomic information, and we’re excited to offer our distinctive solution to estimate TMB and MSI simultaneously and with exceptional accuracy, supported by sophisticated algorithms and rooted in contextual insights from our knowledgebase FoundationCORE,” Miller said. “This is something no other next-generation sequencing platform offers.”

- here's the press release

Related Articles: 
Foundation Medicine up for expedited review by FDA, CMS
Foundation Medicine scores with new regulatory approvals for two Dx tests