Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
Fierce Biotech2d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
American Hospital Association2d
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
MedTech Dive2d
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
Kaleido Scope8mon
Medical Genomics Lab
must be collected in our cell culture media to be viable for testing. Please reach out to our lab at least one week prior to a scheduled biopsy procedure to request the media kit to ensure sufficient ...