"We conduct complete blood count to screen for viral markers such as Human Immunodeficiency Virus (HIV), Human hepatitis B surface antigen (HBsAg), Venereal Disease Research Laboratory test (VDRL ...

The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and ...

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...

A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...

The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate laboratory-developed tests.

When doctors suspect Alzheimer's, they can order a blood test to learn whether a patient's brain contains the sticky amyloid ...

Star Laboratory maintains that all tests were medically necessary, but the OSC asserts that proper documentation is crucial to justify Medicaid billing. A Piscataway-based medical testing ...