BC Extra | Mar 2, 2018
Politics & Policy

Volume of comments delays Foundation coverage decision

After missing the Feb. 28 decision date, the Centers for Medicare & Medicaid Services (CMS) said it will "soon" issue a final National Coverage Determination (NCD) for next-generation sequencing (NGS) cancer diagnostics, including FoundationOne CDx...
BC Innovations | Jan 4, 2018
Strategy

Next generation resolutions

With a slew of landmark approvals in the last 18 months, FDA has solidified its commitment to advancing genetic diagnostics. Now the agency is turning to the outstanding challenges, with solutions on the horizon for...
BC Week In Review | Aug 11, 2017
Clinical News

FDA approves Amgen's sBLA for Vectibix in mCRC

Amgen Inc. (NASDAQ:AMGN) said FDA approved an sBLA for Vectibix panitumumab to treat wild-type Ras metastatic colorectal cancer (mCRC), defined as wild-type in both K-Ras (KRAS) and neuroblastoma Ras viral (v-Ras) oncogene (NRAS) as determined...
BC Week In Review | Jul 6, 2017
Clinical News

FDA approves Illumina's companion diagnostic for Amgen’s Vectibix

FDA approved the next-generation sequencing-based Extended RAS Panel companion diagnostic from Illumina Inc. (NASDAQ:ILMN) to identify wild-type Ras metastatic colorectal cancer (mCRC) patients who are eligible for treatment with Vectibix panitumumab from Amgen Inc. (NASDAQ:AMGN)....
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