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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www.clinicalomics.com January/February 2018 Clinical OMICs 17 principal of an eponymous consulting firm and chair of the Association for Molecular Pathology's Professional Relations Committee. "Because the national coverage determination requires FDA approval of NGS tests as a condition of pay- ment, and also excludes laboratory– developed tests for the 'coverage with evidence development' component of the NCD, unless they are performed as part of an NCI-sponsored trial, it could have profound implications for academic medical centers, patients, and the molecular pathology field as a whole," Klein said. Current clinical trials that would qualify, the CMS spokesperson said, include NCI-MATCH (Molec- ular Analysis for Therapy Choice); ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials); and LUNG-MAP: Phase II/III Biomarker-Driven Master Protocol for Second–Line Therapy of Squamous Cell Lung Cancer. 'Highest Authority' FoundationOne CDx is indicated as a companion diagnostic for patients with certain types of non-small-cell lung cancer, melanoma, colorectal can- cer, ovarian cancer, or breast cancer. "FDA approval of FoundationOne CDx, and with draft Medicare cover- age is another significant development for people living with cancer. Founda- tionOne CDx could arguably be more important, more transformational and have a greater impact for patients and oncologists than when we launched FoundationOne," David Fabrizio, can- cer immunotherapy leader at Founda- tion Medicine, said. "We believe that FDA approval is the highest authority on quality stan- dards and analytic validation. This is why we pursued Parallel Review with FDA and CMS for FoundationOne CDx," Fabrizio added. The company could not quantify the extent of expense savings result- ing from Parallel Review, which has two stages. In the first, the agencies meet with manufacturers to provide feedback on their proposed pivotal clinical trial within the FDA's Center for Radiological Devices and Health (CDRH) Pre-Submission Program. In the second stage, the agencies concurrently review the clinical trial results submitted by manufacturers in pursuit of Pre-Marketing Approval (PMA) or De Novo designation. The FDA said it worked closely with Foundation Medicine, at the compa- ny's request, to enter the agency's Breakthrough Device program. Foun- dationOne CDx won Breakthrough Device status because of its potential to consolidate multiple companion diagnostic claims for patients and healthcare providers in a single test. Seeking Innovation and Impact "Generally speaking, the FDA and CMS consider for Parallel Review studies of highly innovative products that will significantly impact Medicare beneficiaries as well as PMA and De Novo products that require clinical data," an FDA spokesperson said. FDA and CMS seek patient health outcome evidence such as quality of life, functional status, duration of (continued on next page) zimmytws / Adobe Stock

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