If the tenor of the overflow crowd at November’s Association for Molecular Pathology (AMP) Annual Conference to hear FDA’s Alberto Gutierrez, Ph.D., is any indication, the agency’s move to tightly regulate laboratory developed tests (LDTs) faces an uphill battle to win over those who run the thousands of molecular pathology…

The FDA said Thursday it intends to regulate laboratory-developed tests (LDTs) that it deems as “high-risk” along the lines of Class III medical devices, positioning itself against academic medical centers and other developers of the tests, which have opposed efforts at imposing new rules. The agency formally told Congress it…

Like travelers who roam curious lands, oncologists who delve into tumor genetics may find themselves in need of local guides, experts who will put them on the right path. As far as oncologists are concerned, the right path is the one that leads to an effective therapy, but in difficult-to-treat…