The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye.
More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory framework, according to the FDA. The agency made its plans public in a guidance document that was sent to Congress, as part of legal direction by legislators.
The FDA’s plan is to enforce regulations based on the amount of risk that a test poses to a patient. Tests that are used to diagnose a disease or to decide on a course of treatment will need to be cleared by the FDA before they can be marketed.
Some tests will be excluded from the new requirements: those used in the treatment of very rare diseases where there is no other test; those that resemble the low-tech tests that FDA originally planned not to regulate; and some tests involved in organ transplants.
But the new policy is likely to have a big impact on the increasingly common practice of using genetics to decide how to treat cancer patients.
Read the full, original story: FDA to regulate thousands of cancer, genetic, and other diagnostics