Molecular Testing Labs is Clinical Laboratory Improvement Act (CLIA) certified and College of American Pathologists (CAP) accredited, and all testing is run in compliance with FDA requirements. 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.
Molecular is regulated under CLIA as qualified to perform high complexity clinical testing, the FDA does not require that they be approved. That oversight is regulated by CLIA and CAP. Our CAP certification goes beyond the requirements of CLIA and holds us to an even higher standard.
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.