VHT - Lab-Developed Tests Under FDA Scrutiny: What It Means For Startups | Benzinga
A proposed regulatory shift has injected uncertainty into the laboratory-testing market just as startups advance various tests to detect diseases sooner and personalize treatments.
Startups seizing advances in fields such as genomics and artificial intelligence are designing laboratory-developed tests to spot cancer and other illnesses before symptoms arise and to identify optimal therapies.
Lab-developed tests are created and carried out in a single lab.
Labs perform these tests on blood or other specimens shipped to them. Most genetic tests, for example, are lab-developed tests.
The FDA says it historically has exercised its discretion not to regulate such tests, thus allowing startups to introduce the tests quickly and at relatively low cost.
That would ...