August 03, 2017
Wellesley, Mass., Aug 3, 2017 – Recently in March 2017, the FDA identified more than 1,000 Class II devices that it plans to exempt from 510(k) premarket notification requirements, including many genomic analysis instruments used for diagnostics. The key development is among many reflected in BCC Research’s Quarterly Update of the companion diagnostics (CDx) market.
The new report updates BCC Research’s March 2017 comprehensive report: Companion Diagnostics Technologies and Markets. Informed by the newest available data, this Quarterly Update provides a refreshed analysis of CDx drivers and barriers to adoption, FDA activity around approved therapeutics, required tests and regulation of lab-developed tests, and even includes a new section on reimbursement with updates on the latest developments.
Highlights included details on emerging new information on immune checkpoint inhibitors and their IHC-based diagnostics, on innovation in the BRCA sector, on the progress of liquid biopsy technologies in clinical applications, on infectious disease diagnostics that use next-generation sequencing (NGS), and more. Included is an expanded list of key market players, including new additions Cancer Genetics Inc., Caris Life Sciences, Premier Source, Interpace Diagnostics and Navican Genomics.
Key Updates Include:
“This update includes recent groundbreaking FDA approval of a cancer therapy based on a biomarker result and not the type of cancer according to the body organ, a first for the agency,” says Robert G. Hunter, senior editor healthcare, BCC Research. “In April, the FDA also finally authorized—for the first time—direct-to-consumer tests that provide information on an individual’s genetic predisposition to certain medical diseases or conditions.”
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Companion Diagnostics: Technologies and Markets( BIO077C )
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