Companion diagnostics is changing both the way patients are diagnosed and the way they are treated after a diagnosis is made. These kinds of tests have the potential to greatly impact a wide spectrum of disease areas, especially cancer.
Foundation Medical's new test for solid tumors is a prime example of just how impactful companion diagnostics can be. The first FDA-approved test of its kind, FoundationOneCDx, is designed to identify patients who may benefit from treatment with specific targeted therapies, help inform the use of other targeted cancer therapies, provide a tool for doctors to identify opportunities for patients to participate in clinical trials, and help biopharma companies develop new precision drugs. All of that, in one test.
The Cambridge, MA-based company said the test assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer, or breast cancer to identify patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line treatment for their respective indications. FoundationOne CDx also reports genomic biomarkers that can help inform the use of immunotherapies, genomic alterations in other genes relevant to patient management, and relevant clinical trial information.
According to the company, roughly one in three patients across five common advanced cancers are expected to match with an FDA-approved therapy. The company and its biopharma partners plan to pursue FDA approval for additional companion diagnostics on the platform. The company noted that about 50% of new cancer drugs currently in development are projected to have a companion biomarker.
Along with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary national coverage determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment of the preliminary NCD and an administrative period.
“Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option,” said Andrea Ferris, president and CEO of LUNGevity Foundation. “This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments.”
FoundationOneCDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies, identifies additional alterations in genes known to drive cancer growth, furnishes information about genomic biomarkers, provides relevant clinical trial information, and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.
“Comprehensive genomic profiling is the gateway to precision medicine. This decision from the FDA and CMS, which may lead to coverage for Medicare patients, represents an important step forward in improving patient and clinician access to precision medicine – both in setting a new quality standard for this type of testing and offering potentially improved healthcare coverage,” said Ankur Parikh, medical director of precision medicine at Cancer Treatment Centers of America. “Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options.”
Troy Cox, CEO of Foundation Medicine, said the parallel review decision from FDA and CMS represents a major advancement in personalized cancer care. “Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care."
FoundationOne CDx is the first solid tumor comprehensive genomic profiling test that the agencies reviewed through the Parallel Review program. FDA approval was based on analytic validation and concordance studies with FDA-approved assays, and the company expects the test to be commercially available following finalization of the NCD from CMS.