WIKIMEDIA, DNA LABThe US Food and Drug Administration (FDA) on Thursday (July 31) announced that it will begin regulating medical laboratory testing and will start with the issuance of draft guidelines in the next 60 days. The regulations will require that laboratory tests that were developed in-house in a clinical setting—so-called laboratory-developed tests (LDTs)—and direct-to-consumer diagnostic tests, such as DNA sequencing kits, secure FDA approval.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA Commissioner Margaret Hamburg said in a statement. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”
One of the more high-profile tests that would be subject to the new regulations is Myriad Genetics’ breast cancer risk test, which was at the center of the 2013 Supreme Court decision to invalidate the firm’s patents on the BRCA1 and BRCA2 genes. According to The New York Times, the ...
