The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal. Here are three things to know about ...

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...

Yenos Analytical LLC, a leader in cancer diagnostics using microRNA quantification and nanopore-array detection, today announced the launch of the Yenos cancer test, a new multi-cancer early detection ...

Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...

The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...

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 ...