Regulatory Update

FDA Steps Up Test Enforcement, Saying Tests Need Clearance

Screenshot 2016-03-25 08.33.53THIS MONTH, AT LEAST THREE CLINICAL LABORATORY DIRECTORS got letters from the Food and Drug Administration raising questions about assays for the Zika virus.

The letters say the tests appear to meet the FDA’s definition of a medical device and thus are subject to premarket clearance, approval, or Emergency Use Authorization. In the letters sent to two hospitals in Houston and to MD Biosciences in Minneapolis, FDA requested additional information within seven days, and the three labs said they would comply.

While these letters were news last week, they represent the FDA’s continuing efforts to crack down on how clinical laboratories offer laboratory-developed tests (LDTs) for clinical purposes or to consumers. Last fall, seven clinical labs received letters from the FDA, according to Regulatory Focus, a publication of the Regulatory Affairs Professional Society.

In December, the FDA sent letters to Genomic Express and Healthspek about marketing direct-to-consumer pharmacogenetics tests, saying that three tests from Genomic Express and one from Healthspek are medical devices that the FDA must clear before marketing. Two years ago, FDA proposed to oversee the approval of lab-developed tests and last year, FDA officials said they were taking steps to oversee these tests this year.

Between September and early December, the FDA sent similar letters to five clinical lab companies: Pathway Genomics, DNA4Life, DNA-Cardio-Check, Interleukin Genetics, and Harmonyx, RF reported.

In letters dated March 2, FDA Deputy Director James Woods wrote to James Musser, MD, PhD, Professor of Pathology and Genomic Medicine at the Institute for Academic Medicine at Houston Methodist Hospital, and to James Versalovic, MD, PhD, Pathologist-in-Chief at Texas Children’s Hospital. In the letters, Woods wrote that, as a result of the FDA’s review of the labs’ promotional materials, “we believe you are offering a high-risk test that has not been the subject of premarket clearance, approval or Emergency Use Authorization.”

New Lab Tests For Zika Virus

The Houston Chronicle reported that in February, the hospitals announced the development of a test to detect genetic material from the Zika virus within seven days of the onset of symptoms and would use it only for patients in their hospital systems. Test results are available in a day, the newspaper reported.

On March 4, Woods sent a similar letter to Eddie Moradian, PhD, CEO of MD Biosciences, about MDB’s Zika Virus. In the three letters regarding Zika tests, Woods requested more information.

In response to the FDA’s letters, the Association for Molecular Pathology said on March 14 that it was ‘very concerned and disappointed to see the FDA taking enforcement action” against the Houston hospitals. “Given the ongoing outbreak of the infection and risk of infection in the Houston area, these types of tests are critical for patient care and should be made available to these patients in need,” AMP said.

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