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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24 Clinical OMICs May/June 2018 www.clinicalomics.com carries no CDx indication. As in the past, coverage determinations for NGS-based diagnostic LDTs performed in CLIA-certified laboratories for Medicare patients with advanced cancer will continue to be made by local Medicare Administrative Contractors or MACs. Among companies with MAC-approved LDTs is Caris Life Sciences, which won coverage in 2016 for its flagship NGS offering, MI Tumor Seek; MI stands for "Molecular Intelligence." MI Tumor Seek is an in vitro diagnostic (IVD) NGS assay designed to provide physicians with clinically actionable information on 592 genes including, MSI, TMB, EGFR, ERBB2, KRAS, NRAS, BRCA, and BRAF. The $3,500 test has been ordered by more 10,000 oncologists in 81 coun- tries, and about 40 biopharmas the company said. Caris also offers 13 additional FDA approved/cleared assays, and an additional 23 FDA-registered IVDs through MI Profile, which uses a comprehensive genomic profil- ing-plus approach that assesses DNA, RNA, and proteins. "The result of the [final NCD] decision is going to be a pretty significant expansion and acceptance by the provider community," said David Spetzler, Ph.D., Caris' president and CSO. "When you have events like FDA approval for Foundation Medicine and CMS ratifying payment, that's going to make the entire community more comfortable ordering these types of tests. I think we'll also naturally see a significant increase in the number of providers that start to perform this type of testing, to ensure that there is adequate access for every patient in our country." 'A Lot More' FDA Engagement Spetzler said that he expected the final NCD "is going to promote a lot more engagement with the FDA" for diag- nostic developers. Caris has a pre-submission with the FDA for MICDx, a combined DNA-RNA assay the company is developing, with the goal of improving detection of trans- Commercial Payers Weigh CMS Determination (continued from page 22) With the Centers for Medicare and Medicaid Ser- vices (CMS) approving a coverage framework for NGS tests for advanced cancer, a key question remains: How quickly will commercial payers do likewise? "Private payers are evaluating the Medicare cov- erage decision, and making some determinations about whether or not they'll also cover these tests, and certainly what they'll pay for these tests if they cover them," Chandra Branham, Advanced Medical Technology Association (AdvaMed) vice president, payment and healthcare delivery policy, told Clin- ical OMICs. Global healthcare strategy consulting firm ClearView Healthcare Partners recently surveyed 12 commercial payer medical directors, with many questioning whether the NGS tests have demon- strated clinical utility. The survey found that payers have yet to embrace NGS for broad tumor panel profiling: 45% do not cover the tests, while the remaining 55% only approved coverage on an exceptions-only basis. Over the next one to two years, however, most payers (75%) expect their commercial coverage of NGS in oncology to fall in A Thermo Fisher scientist hold an NGS sample vial. A clinical lab scientist at Cancer Genetics, Inc. processes a non-small cell- lung cancer sample for testing using Thermo Fisher Scientific's Oncomine Dx Target Test.

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