The Enhancing CLIA Act, introduced in Congress as H.R. 8890, proposes modernizing the CLIA framework for laboratory-developed tests and reaffirms CMS—not FDA—oversight of LDTs, signaling potential regulatory changes for labs.
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Magnolia Diagnostics and its owners will pay $19.2 million to resolve DOJ claims of billing Medicare for unnecessary respiratory tests with COVID-19 screening; investors will pay an additional $4.8 million for related allegations.
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As laboratories weigh new hemostasis investments, Sysmex experts discuss the questions that can help guide system selection.
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The request for information addresses advancements in technology, including artificial intelligence and cybersecurity, to inform potential changes to 1992 rules.
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Roche has developed a rapid PCR assay for the rare Ebola Bundibugyo virus, enabling research-use detection within six days to support outbreak response in Central and East Africa, according to the company.
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