Gene Solutions, a global biotechnology company, and Pangea Laboratory, a CLIA-certified, CAP-accredited Next Generation Sequencing (NGS) leader in validation platforms for Laboratory Developed Tests ...

The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...

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 ...

Gene Solutions, a global biotechnology company, and Pangea Laboratory, a CLIA-certified, CAP-accredited Next Generation ...

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 ...

These tests are typically not advertised or sold as kits to other testing facilities. The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity ...

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 ...

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 ...

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 ...

A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...

As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly dialed back after President-elect Trump is sworn in. The big picture: ...