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

Health and Human Services Secretary Robert F. Kennedy Jr. has eliminated the Centers for Disease Control and Prevention's ...

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

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

Royal Oldham Hospital's FlexLab X can process up to 15,525 blood test tubes every hour. The hospital said this would ...

Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in ...

Dermaclaim is a dermocosmetic testing laboratory, located in Valencia (Spain), focused on the substantiation of efficacy ...

A team of Northwestern University scientists spanning disciplines have developed new technology that could lead to the ...

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

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

The automated DxC 500 I analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour.