RE:ColonSentry®davewho... Good point, In the link below you will notice that three Federal Agencies are responsible for CLIA, including the Food And Drug Administration (FDA).
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia davewho wrote: ColonSentry® uses the company's proprietary Sentinel Principle technology which is based on the scientific observation that circulating blood reflects, in a detectable way, what is occurring throughout the body. Today, more than 100,000 patients in the U.S. have benefited from the ColonSentry test. GeneNews' next generation test, Aristotle®, will use this proven technology to test for ten cancers from a single blood sample. In addition to building a pipeline of products for early cancer detection, GeneNews operates a CAP accredited and CLIA certified, clinical reference laboratory based in Richmond, Virginia that offers the ColonSentry® test as well as licensed biomarker tests for lung, breast and prostate cancers.
Hard to believe they can do all that without FDA approval?