Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory ...

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products" to specify that such definition "[includes] when the ...

A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...

After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...

CARLSBAD, Calif.--(BUSINESS WIRE)--Life Technologies Corporation (NASDAQ: LIFE), a provider of innovative life science solutions, today announced the launch of the EZValidation Online Tool, which ...

Experts in the health sector have called for the enactment of a legislation that would peg the minimum standards before clinical laboratories can be established and operated. They made the call at the ...