Lab-developed test lawsuits to be consolidated
October 2024—The two lawsuits filed by the American Clinical Laboratory Association and Association for Molecular Pathology that challenge the Food and Drug Administration’s final rule on laboratory-developed tests will be consolidated in the U.S. District Court for the Eastern District of Texas, according to a motion filed Sept. 9.
During the weeks of Aug. 26 and Sept. 2, the parties to both actions conferred on how to litigate both cases “in a just, speedy, and efficient manner,” the motion says. It adds that all parties in both cases consent to the transfer of the AMP case to the Eastern District “and agree that, subject to this Court’s discretion, the two cases then should be consolidated for joint briefing and decision.”
The AMP had filed its case, Association for Molecular Pathology v. FDA, in the Southern District of Texas.
The parties filed their joint notice to apprise the court of the AMP case and of a joint motion to transfer that case to the Eastern District of Texas. All parties in both cases conferred and agreed on a schedule that will allow for consolidated briefing on dispositive motions in both cases.
Amicus briefs in support of the plaintiffs were to be due by Oct. 7. ACLA’s and AMP’s closing briefs would be due by Nov. 25, and the FDA’s closing brief would be due by Dec. 23.
On May 6 the defendants published a final rule announcing their intent to regulate laboratory-developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act.
In related news, the Association for Diagnostics and Laboratory Medicine conducted a survey (n=121) in which 48 percent of laboratories said if they don’t qualify for an exception under the FDA final rule, they will discontinue performing LDTs that require a 510(k), de novo, or premarket application. The others said they will file a submission.
CDC partners with five labs for avian flu test development
The Centers for Disease Control and Prevention selected ARUP Laboratories and four other laboratories as formal partners in the development of a test for avian influenza A (H5N1). The others are Quest Diagnostics, Labcorp, Aegis Sciences, and Ginkgo Bioworks.
The partnership marks a shift for the CDC in that it enables commercial laboratories to work on testing solutions alongside the agency, rather than once a public health emergency arises, to make a test for bird flu available quickly if it is needed, ARUP said in a Sept. 13 press release.
“ARUP wants to be a fully integrated partner in the delivery of public health services and clinical laboratory testing, and this contract opens doors for both,” Marc Couturier, PhD, ARUP’s head of clinical operations for clinical microbiology and immunology and medical director of emerging public health crisis, parasitology/fecal testing, and infectious disease antigen testing, said in the release.
The announcement came shortly after an individual in Missouri, who had no known contact with animals or poultry, became infected with an H5 virus. It is the first time a human has tested positive for H5 without a known source of the virus.