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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Palmetto Issues New Codes For BRCA, “Hotspot” Testing
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Congressional Members Lobby CMS on PAMA Regulations
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HHS’ Top Ten Management Problems Include Labs
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ACMG Issues Position Statement on Direct-to- Consumer Tests
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Congress Lobbies CMS on PAMA Regulations
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FDA Looks Back at Successes and Details Plans for 2016, Including LDTs
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Pathway Genomics Denies Wrongdoing, Settles False Claims Allegations for $4 Million
From - G2 Compliance Advisor
As the year came to a close, the Federal Bureau of Investigation and the U.S. Attorney's Office announced December 30, 2015, a $4 million settlement with Pathway Genomics. The San Diego-based laboratory denied wrongdoing but agreed to pay that sum to resolve…
NeoGenomics Completes Clarient Acquisition
From - Laboratory Industry Report
Florida-based NeoGenomics has completed its acquisition of the Clarient Diagnostics unit from GE Healthcare. Clarient provides cancer diagnostics to hospitals, physicians, and drug companies…
CDC Year in Review and Future Plans Include Laboratory Safety
From - G2 Compliance Advisor
Laboratory safety and diagnosis of infections figure prominently in the Centers for Disease Control and Prevention's (CDC) review of 2015 and its agenda for 2016. The agency's Year in Review highlighted "the most pressing public health challenges of…
News at a Glance – Jan 2016
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