CAP, CLIA, and the FDA
Many of our assays are quite novel, leveraging technologies to make it easier for patients to be active participants in their care.
Because of the novelty, we do not submit all of our assays to the FDA. However, this does not mean that we don't take our validations and compliance very seriously.
Since Molecular is regulated under the Clinical Laboratory Improvement Act (CLIA) of 1988 as qualified to perform high complexity clinical testing, the FDA does not require that they be approved. Rather, that oversight is regulated by CAP (College of American Pathologists) and CLIA. Our CAP certification goes beyond the requirements of CLIA, and holds us to an even higher standard (the highest in the world for laboratory testing).
Laboratory Director: Dr. Charles Sailey
With appropriate oversight (e.g. CAP, CLIA, trained medical director, etc.), there is no need for direct FDA intervention. More than 85% of all laboratory testing in the US is performed on platforms and equipment that has not been FDA cleared.