FDA-Cleared Biomarker Tests Are On The Upswing

by John Audette | Apr 24, 2014 | Analysis, Regulation

As previously reported in this blog, review periods for biomarker-based IVD tests were shorter in 2013 for the second year in a row. This continued the reversal of a decade-long trend of increasing review periods.

Market-based Reimbursement Provisions for Lab Tests Passes Senate with Industry Backing (GenomeWeb)

by John Audette | Apr 04, 2014 | News, Reimbursement, Regulation

Key provision of the bill: "According to section 216 of HR 4302, starting in 2017 CMS will pay labs according to the weighted median of rates from private payors for tests. Labs will have to begin reporting rates from payors to CMS in 2016." Plus special treatment for multiplex assays: "Although ...




Pharmacovigilance and Safety Biomarkers

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