NEW YORK (GenomeWeb News) – The US Food and Drug Administration has notified CombiMatrix that its microarray-based diagnostic service for identifying genetic disorders does not fall under its recent guidance covering in vitro diagnostic multivariate index assays, and therefore will not be subject to some new regulations.
In a letter from the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, which sets guidelines for molecular diagnostics and personalized medicine, office director Steven Gutman wrote that CombiMatrix’s Constitutional Genetic Array Test does not meet the definition of an IVDMIA.
In a copy of the OIVD letter provided by CombiMatrix, Gutman wrote, “We do not believe that your device, as described, meets the definition of an IVDMIA as defined in the Draft Guidance document on IVDMIAs.”
The FDA released the IVDMIA draft guidance, which outlines the regulatory rules for companies and labs that manufacture these tests, on Sept. 6.
The FDA defines IVDMIAs as tests that use an algorithm to generate results from multiple data points, including protein and genetic data.
CombiMatrix said the letter followed a September meeting to discuss CGAT with OIVD officials at the company’s lab, after which the agency decided the test did not require FDA oversight. This opinion has freed the company to pursue marketing its CGAT without regulatory considerations.
CombiMatrix said the OIVD opinion presently applies only to the CGAT, but asserted that its strategy will be to develop a series of array-based molecular diagnostic services as laboratory-developed tests, and potentially to seek FDA approval to sell some tests to other labs.