Vince Miller, MD
In December, Foundation Medicine, a leader in the field of molecular testing, strengthened its industry position by gaining its first FDA approval for a companion diagnostics test: Foundation Focus CDx BRCA
, which can detect both germline and somatic BRCA1/2
mutations in women with ovarian cancer who are candidates for the PARP inhibitor rucaparib (Rubraca). The test also is the first next-generation sequencing-based companion diagnostic that the agency has approved.
Miller said Foundation Medicine is now anticipating FDA approval of the large-panel FoundationOne assay as a universal companion diagnostic, which he said would be key to the company’s fortunes. Using next-generation sequencing, the assay can test for more than 300 cancer-related genes. However, Miller said various other barriers exist. Genetic testing needs to become a routine part of the therapeutic process, and doctors need help in interpreting the actionable results of these complex tests, he said.
What sets the large-panel test FoundationOne apart from other genomic assays?
We know there’s an increasing number of targeted therapies, and that even though a certain percentage will not be approved by the FDA, the trend is that as each month goes by, more and more targeted therapies are available to patients. A growing number of these treatments are also associated with companion diagnostics tests.
Not only are we synching up patients with FDA-approved drugs for given indications, but also we can match patients from a DNA standpoint with many different targeted therapy clinical trials. There are more than 1000 targeted therapeutics across over 100 genes of interest under study presently, and several thousand trials involving those targeted therapeutics. So, this is a great tool to allow a doctor treating patients with cancer to see if their patient is eligible for an FDA-approved therapy or to evaluate, from a molecular standpoint, whether they’re eligible to participate in specific clinical trials.
What’s the FDA approval status for FoundationFocus CDx BRCA and FoundationOne?
We recently had our first FDA approval of a companion diagnostic that was developed as the assay for Clovis Oncology’s drug rucaparib and that’s FoundationFocus CDx BRCA
. It detects both germline and somatic BRCA1/2
mutations in women with ovarian cancer to predict increased sensitivity to that drug.
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