BioCentury
ARTICLE | Company News

Biocartis submits Idylla to FDA, partners with Amgen

December 23, 2016 12:18 AM UTC

Biocartis Group N.V. (Euronext:BCART) said it submitted molecular diagnostics platform Idylla to FDA via the 510(k) pathway. Separately, the company announced a deal with Amgen Inc. (NASDAQ:AMGN) to evaluate Ras biomarkers for metastatic colorectal cancer (mCRC) using the platform in up to 10 European countries. Biocartis gained EUR 0.75 to EUR 10.46 on Thursday.

Biocartis already markets Idylla outside the U.S., along with several tests based on the platform for specific biomarkers. Last month, the company granted Thermo Fisher Scientific Inc. (NYSE:TMO) U.S. distribution rights to Idylla (see BioCentury Extra, Nov. 17)...