- Yesterday, the FDA shared the first test report and detailed data from the independent validation study performed at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI), which data were used to support an EUA request. The results come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests. While the EUA request was not granted solely based on the validation data, the data were leveraged to inform FDA’s decision making. The NCI FNLCR test report provides new details on the testing that is being performed by NCI. Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.
- Yesterday, the FDA issued an Emergency Use Authorization (EUA) to Sherlock BioSciences, Inc.’s Sherlock CRISPR SARS-CoV-2 Kit. This test is the first authorized use of CRISPR technology for an infectious disease test. The Sherlock CRISPR SARS-CoV-2 Kit is a CRISPR-based SHERLOCK (Specific High sensitivity Enzymatic Reporter unLOCKing) diagnostic test that looks for the specific target RNA or DNA sequences of the SARS-CoV-2 virus in upper respiratory specimens, such as nasal swabs, and bronchoalveolar lavage specimens, such as from fluid in the lungs, from individuals suspected of COVID-19 by their healthcare provider. Use of the test is limited to laboratories certified under CLIA to perform high-complexity tests.
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