Reports that the United States Food and Drug Administration has cleared for commercial marketing two new laboratory tests. IDI-Strep B test made by Infectio Diagnostics Inc. for pregnant women; NT proBNP test made by Roche Diagnostics to detect levels of a peptide linked to congestive heart ...
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test makers support, and that laboratories are likely to dispute. When the FDA started regulating medical devices in 1976, lab-developed tests were simple and offered mostly to local patient populations. The agency generally allowed labs to use these tests without submitting proof of their efficacy...
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The Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care. The test from California-based Cepheid will deliver results in about 45 minutes — much faster than current tests that require a sample to be sent to...
The U.S. Food and Drug Administration (FDA) has approved the first at-home over-the-counter syphilis test. The new test comes from the biotech company NOWDiagnostics. It will take the user just 15 minutes with a single drop of blood to determine if they have syphilis. ...