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FDA Warning Letter
FDA warns of shortage of blood sample collection tubes
The FDA said that the U.S. has been "experiencing significant interruptions" in the supply of blood-draw tubes during the COVID-19 public health emergency. The agency in June 2021 issued a letter to labs and healthcare facilities warning of a shortage of sodium citrate blood specimen collection (light blue top) tubes.
January 18, 2022
FDA puts kibosh on use of Innova Medical coronavirus test
In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
June 9, 2021
FDA ups its game in oversight of pharmacogenetic tests
In a statement on February 20, the agency explained that its Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) are collaborating on the monitoring and review of evidence supporting pharmacogenetic (PGx) tests, which are used to match medications to patients based on genetic profiling.
February 19, 2020
ACLA blasts FDA's 'troubling actions' on pharmacogenetic tests
ACLA President Julie Khani spelled out the association's concerns and requested a meeting in a September 18 letter to FDA Acting Commissioner Dr. Ned Sharpless; Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health; and Dr. Timothy Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health.
September 18, 2019
AMP spells out how labs should report genetic test results
The AMP endorsed the use of evidence-based guidelines for pharmacogenomic tests in clinical practice from the international Clinical Pharmacogenetics Implementation Consortium (CPIC). Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA), the AMP noted.
September 3, 2019
Myriad's GeneSight woes reflect closer FDA oversight
The company's stock plunged by 42.76% on August 14, to a close of $25.50. In its report for its fiscal fourth quarter (end-June 30), Myriad reported sales of $29.8 million for GeneSight, down by 12% from the same period in 2018. For all molecular diagnostic products, the company reported quarterly sales of $196.9 million, up 9% from the same period in 2018.
August 13, 2019
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
C2N Diagnostics launching next-generation blood test for Alzheimer's disease detection
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
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