The FDA has finalized guidance detailing validation requirements for in vitro diagnostic tests for emerging pathogens during public health emergencies, aiming to help manufacturers prepare for future outbreaks.
An FDA advisory panel voted 7-2 that the benefits of GRAIL’s Galleri multi-cancer early detection blood test outweigh its risks for adults 50 and older, supporting its premarket approval application.
A new SHEA framework outlines how targeted diagnostic stewardship interventions could save a 200-bed hospital up to $2.8 million annually.
The new concurrent survey model aims to reduce administrative burden and promote operational consistency across healthcare systems.
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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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The request for information addresses advancements in technology, including artificial intelligence and cybersecurity, to inform potential changes to 1992 rules.
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Labcorp will pay $14.5 million to settle DOJ allegations it billed Medicare for medically unnecessary urine drug tests by submitting claims for both presumptive and definitive testing on the same sample between 2018 and 2023.
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Hair drug test positivity among US workers rose to 19.1% in 2025, a 46% increase since 2021, with marijuana accounting for over half of positive results, according to the 2026 Quest Diagnostics Drug Testing Index.
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The settlement resolves claims that Advanced Pathology Solutions provided illegal incentives to gastroenterology practices and performed unnecessary medical testing.
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A new federal bill, the Enhancing CLIA Act of 2026, seeks to update oversight of laboratory-developed tests following a 2025 court decision, proposing a two-year delay for new requirements and a voluntary pathway for existing device clearances.
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The ADLM honored senator Shelley Moore Capito for advancing pediatric reference intervals, citing her support for related provisions in Senate appropriations bills for FY 2025 and 2026.
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The funding, allocated to the Centers for Disease Control and Prevention, aims to establish more accurate normal ranges for children’s medical results.
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Laboratories must now pay fees online and access certificates electronically as the program ends paper mailings.
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The authorization from the New York State Department of Health makes the screening test available in all 50 states.
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The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.
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Applicable laboratories are required to report information to CMS for each clinical diagnostic laboratory test that the laboratory furnishes.
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A new analysis finds that policy and payment gaps are limiting access to diagnostics, with nearly half the world lacking adequate testing and reimbursement lagging behind advances in precision therapies.
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The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.
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