Foundation Medicine has gained FDA approval and a concurrent coverage proposal from the Centers for Medicare & Medicaid Services (CMS) for its FoundationOne CDx™ cancer test, a companion diagnostic designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.
FoundationOne CDx is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) device created to detect substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements.
The test is Foundation Medicine’s flagship assay for solid tumor cancers and is 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.
FoundationOne CDx is intended to identify patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 that are now approved as first-line therapies. The test is also designed to detect genomic signatures, including microsatellite instability (MSI) and tumor mutational burden (TMB), using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
FoundationOne CDx 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, including MSI and TMB, provides clinical trial information, and includes interpretation.
According to the FDA, FoundationOne CDx differs from other companion diagnostics previously approved by the agency, which match one test to one drug.
“Today's historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” Foundation Medicine CEO Troy Cox said in a company statement. “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.”
Second Parallel Review Approval
FoundationOne CDx is the second IVD to be approved and covered following parallel review by the FDA and CMS. The first came in 2014, when the agencies approved and agreed to cover Exact Sciences' Cologuard®, the first noninvasive DNA screening test for colorectal cancer and the first stool-based diagnostic designed to indicate the presence of red blood cells and DNA mutations that may indicate certain kinds of abnormal growths that could indicate cancer.
According to the agencies, parallel review is intended to speed up access to innovative medical technologies for Medicare beneficiaries by allowing test developers to gain approvals plus an immediate proposed Medicare coverage determination from CMS within six months of FDA receipt of a product application.
The program is open to some premarket approval applications for devices with new technologies, as well as to medical devices that can be classified within a Part A or Part B Medicare benefit category and have not been subject to a national coverage determination.
“By leveraging two policy efforts aimed at expediting access to promising new technologies, we’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs,” FDA Commissioner Scott Gottlieb, M.D., said in a separate statement released by his agency.
As a laboratory-developed test, for which the FDA has not enforced premarket review and other requirements, FoundationOne CDx had not been previously submitted for agency review. But at Foundation Medicine’s request, the FDA granted the test its granted Breakthrough Device designation applicable to devices deemed to provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists, or that offer significant advantages over current standard of care.
“Least Burdensome” Standard
The FDA established the test’s clinical performance using a “least burdensome” standard in which FoundationOne CDx was compared to previously agency-approved companion diagnostic tests. The test showed approximately 94.6% accuracy in detecting substitutions and short indels representative of the entire 324-gene panel, the FDA said.
The FDA divided its assessment of FoundationOne CDx into a clinical review conducted by the Center for Devices and Radiological Health (CDRH), with support from the agency’s Oncology Center of Excellence, and a review of all other aspects of the test, followed by a final approval determination by the CDRH.
Concurrent with FDA approval, CMS has issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx and other similar NGS IVDs for Medicare beneficiaries with advanced cancer—including recurrent, metastatic, or advanced Stage IV cancer—who have not been previously tested using the same NGS technology and continue to seek further cancer therapy.
The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence of development in other solid tumor types, Foundation Medicine said.
The final policy is expected to issue during the first quarter of 2018 following periods of public comment and administrative review. Upon finalization of the NCD, FoundationOne CDx is expected to be commercially available, Foundation Medicine said.