On Tuesday, the FDA published comparative performance data for some authorized covid-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic covid-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their emergency use authorization (EUA). The data published gives laboratories, healthcare providers, and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. The FDA will continue to update the table as it receives additional results. For more information, visit FDA.
Sema4, GeneDx Collaborate on Research Demonstrating Diagnostic Certainty of Genome and Exome Sequencing
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