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.
The National Kidney Registry implemented a seven-day serology testing window for organ transplants starting Aug 10, 2026, aligning with new OPTN emergency policies and extending the timeline to all 23 serology tests.
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.
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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The owner of an Oregon clinical laboratory allegedly submitted tens of millions in fraudulent claims to Medicare Advantage plans for laboratory testing services that were never ordered or performed.
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An Alabama-based physician received a 16-month prison sentence for signing off on medically unnecessary genetic tests and durable medical equipment orders, resulting in millions in false Medicare claims.
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State audit finds the lab billed for drug tests without required physician signatures in nearly a quarter of reviewed instances.
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State regulators say the companies collected specimens without authorized provider orders, violating Hawaii law.
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The compliance milestone adds to the company’s existing ISO certifications as enterprise deployments accelerate across pharmaceutical and diagnostic laboratory customers.
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The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.
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The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.
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The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.
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AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
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Settlement resolves False Claims Act litigation alleging illegal payments disguised as management service organization distributions.
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