Caris Life Sciences Applauds CMS Decision to Reaffirm the Longstanding Coverage for Its Next-Generation Sequencing Assay

Medicare patients remain covered and continue to have access to Caris’ NGS assay for solid tumors that includes 592 genes, Microsatellite Instability (MSI) and Tumor Mutational Burden (TMB)
IRVING, Texas, March 21, 2018 – Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today confirmed that the new National Coverage Decision (NCD) by the Centers for Medicare & Medicaid Services (CMS) reaffirms coverage the company has had since 2016 for its flagship next-generation sequencing (NGS) offering, MI Tumor Seek, which supplies physicians with clinically important genomic information on key biomarkers and molecular signatures in oncology, across all solid tumors.
“We are pleased with the reaffirmation of the longstanding coverage of our next-generation sequencing assay, MI Tumor Seek,” said David D. Halbert, Chairman and Chief Executive Officer of Caris Life Sciences. “Contrary to a misleading press release from another company in tumor profiling, which has been repeated by several media outlets, the CMS ruling broadens the scope for a range of commercial and academic laboratories to provide critical tumor profiling services to cancer patients.  As the longest provider of molecular profiling services in oncology, Caris welcomes this important decision which reinforces the importance of this service in improving patient care.”
MI Tumor Seek is an in vitro diagnostic NGS assay that provides physicians clinically actionable information on 592-genes including, MSI, TMB, EGFR, ERBB2, KRAS, NRAS, BRCA and BRAF, among others. Caris also offers an additional 13 FDA approved/cleared assays and an additional 23 that are registered IVDs with the FDA through MI Profile, which uses a comprehensive genomic profiling plus approach that assesses DNA, RNA and proteins.
“As the first comprehensive tumor profiling provider, we recognized very early that molecular profiling enables oncologists to offer more precise treatment strategies for their patients,” said David Spetzler, M.S., Ph.D., M.B.A., President and Chief Scientific Officer of Caris Life Sciences.  “Over the last decade we’ve continuously implemented the latest technological advances to our tumor profiling offering ensuring physicians have the molecular intelligence needed to improve clinical care.”
The final NCD policy covers NGS diagnostic laboratory tests for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory or stages III or IV cancer) and extends coverage to repeat testing when the patient has a new primary diagnosis of cancer. NGS tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage (provided all criteria are met), and coverage determinations for laboratory developed tests performed in CLIA-certified laboratories, such as Caris Life Sciences, will continue to be made by local Medicare Administrative Contractors (MACs).
About Caris Life Sciences®
Caris Life Sciences® is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation, and the world’s leading immunotherapy diagnostic expert. Caris Molecular Intelligence®, the company’s Comprehensive Genomic Profiling Plus (CGP+) molecular testing service, assesses DNA, RNA and proteins, including microsatellite instability (MSI), tumor mutational burden (TMB) and PD-L1, to reveal a molecular blueprint to guide more precise and personalized treatment decisions. The ADAPT Biotargeting System, the company’s revolutionary and unbiased profiling platform, is currently being utilized for drug target identification, therapeutic discovery and development, fixed tissue-based companion diagnostics, blood-based cancer screening and biomarker identification. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit
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Source: Caris Life Sciences