Clinical OMICS

MAY-JUN 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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www.clinicalomics.com May/June 2018 Clinical OMICs 21 microsatellite instability (MSI) and tumor mutational bur- den (TMB) using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens. "As the FDA moves toward biomarker driven drug approvals that are tumor agnostic, like pembrolizumab [Merck & Co.'s cancer immunotherapy Keytruda] with MSI, having a test that is FDA approved, is mapped to a broad range of companion diagnostics, interrogates the entire cancer genome and provides TMB and MSI scores on every patient report, could have a dramatic impact on clinical care," said Gary Martucci, senior vice president, reimburse- ment and payer strategies at Foundation Medicine. FoundationOne CDx became commercially available on March 30 at a list price of $5,800. For Medicare beneficia- ries meeting NCD criteria, there is currently no anticipated co-pay or deductible amounts. CMS coverage also includes beneficiaries that are enrolled in Medicare Advantage plans. Depending on a member 's plan, they may be subject to a co-pay or deductible. But for those patients, some may be eligible for Foundation Medicine's FoundationAccess pro- gram to assist with out-of-pocket expenses, Martuccis noted. Automatic Approvals FoundationOne CDx is among four NGS cancer tests that received FDA approval or clearance as an in vitro compan- ion diagnostic, and thus automatically approved for cover- age under the final NCD. The other three: • Foundation Medicine's FoundationFocus CDxBRCA, designed to detect tumor BRCA1 and BRCA2 muta- tions, germline and somatic, in ovarian cancer. CDx- BRCA has FDA approval as a companion diagnostic assay for Clovis Oncology's Rubraca (rucaparib), a poly ADP-ribose polymerase (PARP) inhibitor indi- cated for advanced ovarian cancer. • Illumina's Praxis Extended RAS Panel, approved for use with the company's MiSeqDx System to help clinicians identify patients eligible for treatment of metastatic colorectal cancer with Amgen's Vectibix (panitumumab). • Thermo Fisher Scientific's Oncomine Dx Target Test, designed to detect 368 variants in 23 cancer-associ- ated genes clinically associated with non-small cell (continued on next page) Foundation Medicine Caris Life Sciences

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