Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...
The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab tests ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
Lateral flow assays have been a popular point-of-care testing platform for decades. Researchers are now turning these simple tests into complex biomedical assays which can be used in the home, ...
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