Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been conducting to determine how the Food and Drug Administration's (FDA's) final laboratory developed tests rule will impact patient care. The survey found that, under the FDA rule, individuals from rural and historically marginalized communities will have severely limited access to vital tests, which could lead to harmful and even life-threatening delays in diagnosis and treatment.

The Association for Molecular Pathology and Michael Laposata, a pathologist at the University of Texas Medical Branch-Galveston, have filed a lawsuit against the US Food and Drug Administration challenging the agency's May 6 final rule on laboratory-developed tests (LDTs).

Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs).

The US Food and Drug Administration released on Monday its final rule to regulate laboratory-developed tests (LDTs).

DiaCarta said Monday that it has formed a strategic partnership with New Jersey-based contract research organization Hopkins MedTech Compliance/Hopkins MedTech Lab Services to provide validation and regulatory compliance services for laboratory test and in vitro diagnostic developers in the US.

In October 2022, the Office of the Leading Group for Deepening Medical and Health System Reform in Shanghai issued the Notice on Piloting the High-Quality Development of Public Hospitals in Shanghai.

On October 15, the General Office of Hangzhou Municipal People's Government issued the "Notice on Several Measures to Accelerate the High-Quality Development of Biomedical Industry"

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done.

Consumer advocates say the proposed legislation has too many exemptions, while industry groups seek to limit premarket review requirements for legacy tests.

Genetron Health on Tuesday reported a 38 percent year-over-year increase in its second quarter revenues amid strong growth in sales from its LDT and IVD segments.