“The mini-labs provide a flexible test environment that delivers real measurement data,” Gamella said in a statement.

The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s ...

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

The lack of a conclusive determination left the Supreme Court questioning the reliability of the testing process itself.

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.

BETHLEHEM TWP., Pa. - A new initiative in Northampton County will provide no-cost lead testing for children. “Walk-In ...

New Day Diagnostics' blood test is an alternative means of colorectal cancer screening, which doctors recommend starting at ...

A Salisbury man has been charged after lab tests connected him to a shooting case last year. Police say the shooting happened ...

A New Jersey laboratory which had parts of its business acquired by Labcorp earlier this month has laid off 81 employees.

Locke Bio, a leading telehealth platform, has partnered with imaware, a premier lab-testing provider, to integrate comprehensive diagnostic testing into its digital healthcare ecosystem. This ...

The Molten Salt Flow Loop Test Bed is meant to allow for continuous, real-time monitoring and analysis that makes molten salt research more efficient.