Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Diagnostics 16 Clinical OMICs January/February 2018 www.clinicalomics.com Parallel Lines FDA, CMS Pursue Concurrent Reviews for 'Innovative' Diagnostics By Alex Philippidis F oundation Medicine's FoundationOne CDx assay for solid tumor cancers is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) device intended to identify patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 approved as first-line therapies. Since November 30, the cancer test has enjoyed yet another distinction. FoundationOne CDx is the second IVD to win FDA approval and a concurrent coverage proposal from the Centers for Medicare & Medicaid Services (CMS) through their Parallel Review Program. The FDA authorization for FoundationOne CDx is the agency's first for a comprehensive genomic profiling test for all solid tumors incorporating multiple companion diag- nostics. FoundationOne CDx is designed to detect substitu- tions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrange- ments. It is also designed to detect genomic signatures, including microsatellite instability and tumor mutational burden, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. Foundation Medicine also received a proposed National Coverage Determination (NCD) from CMS for Founda- tionOne 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 proposed NCD would provide coverage for FDA-ap- proved companion diagnostic claims, and a pathway for additional coverage with evidence of development in other solid tumor types. A final NCD is expected to be approved during the first quarter of 2018 following public comment and administrative review. Four Other Tests Would Qualify Should that approval occur, four additional NGS diagnostic tests would qualify for coverage. One is Thermo Fisher Sci- entific's Oncomine Dx Target Test, a cancer assay which on December 7 received a CMS coverage proposal. The others: • Foundation Medicine's FoundationFocus CDxBRCA, designed to detect tumor BRCA1 and BRCA2 mutations, germline and somatic, in ovarian cancer. CDxBRCA has FDA approval as a companion diagnostic assay for Clovis Oncology's Rubraca; • Illumina's Praxis Extended RAS Panel, an FDA- approved NGS IVD for use with the company's MiSeqDx System to help clinicians identify patients eligible for treatment of metastatic colorectal cancer with Amgen's Vectibix; and • Memorial Sloan Kettering Cancer Center's MSK- IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), a 468-gene panel designed to detect gene mutations and other critical genetic aberrations in rare and common cancers. In November, MSK- IMPACT became the first tumor-profiling laboratory- developed test (LDT) to win FDA approval. By speaking to NGS as a technology, rather than being directed solely to the FoundationOne test, CMS' proposed coverage decision is controversial among many molecular pathology stakeholders, said Roger D. Klein, M.D., J.D., "The program is most suitable for newer tests and technologies, for which Medicare coverage is questionable, and the decision complex." —Roger Klein, M.D., industry consultant

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