FDA Provides Positive Opinion On The Regulatory Status Of CombiMatrix’s First Array-Based Molecular Diagnostic

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Acacia Research Corporation (Nasdaq:CBMX) (Nasdaq:ACTG) announced today that its CombiMatrix group has received a letter from the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) of the US Food and Drug Administration (FDA). The text of the letter is given below. The letter states that the FDA is not defining CombiMatrix’s first commercial microarray-based molecular-diagnostic service, the Constitutional Genetic Array Test (CGAT), as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA). Thus the test does not require regulation covered in the FDA’s Draft Guidance document issued on September 5, 2006.

>>> Discuss This Story

MORE ON THIS TOPIC