BioCentury
ARTICLE | Politics & Policy

MEDCAC mixed on cancer diagnostics

May 2, 2013 1:35 AM UTC

CMS's Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) concluded on Wednesday that existing evidence is sufficient to confirm the clinical validity of DNA- or RNA- based testing to predict the tissue of origin for cancer of unknown primary site. However, the panel was less confident there is sufficient evidence to determine if the tests affect health outcomes. On the question of clinical validity, the average vote of the 12-member panel was 3.25 on a scale of 1-5, where 1 is "low confidence" and 5 is "high confidence." On the question of health outcomes, the average vote was 2.08.

There are at least three DNA- or RNA-based tests marketed in the U.S. to identify the tissue of origin for a tumor, including miRview mets2 assay from Rosetta Genomics Ltd. (NASDAQ:ROSG) and Precision Therapeutics Inc. (Pittsburgh, Pa.); Tissue of Origin test from Pathwork Diagnostics Inc. (Redwood City, Calif.) and CancerTYPE ID test from bioMerieux S.A. (Euronext:BIM). Rosetta was off $0.02 to $3.30 on Wednesday, while bioMerieux was up EUR 0.09 to EUR 72.19. ...