Brian Casey

Microbiology
LabPulse.com Microbiology Insider
Dear Microbiology Insider,
May 17, 2022
Alzheimer's
FDA grants approval for Fujirebio assay for Alzheimer's plaques
The FDA granted clearance under its breakthrough device pathway to Fujirebio's Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is designed to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40. These are proteins that can accumulate and form plaques in the brain; concentrations of these proteins can be detected in cerebral spinal fluid (CSF).
May 3, 2022
2022 05 04 20 54 3251 Computer Brain Hemisphere 400
Moderate Complexity Test
FDA tightens policy on reviews of lab-developed tests
In a November 15 press release, the FDA said it was withdrawing its policy that directed the agency to not enforce premarket review requirements for LDTs. The agency said it was taking the action to "help ensure that COVID-19 tests are accurate and reliable."
November 14, 2021
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
Plague
House probe says Trump officials changed COVID-19 testing rules
In a November 12 press release, the House select subcommittee on the coronavirus crisis included a critique of the performance of neuroradiologist Dr. Scott Atlas as President Trump's special advisor on dealing with the pandemic. The subcommittee, chaired by Rep. James Clyburn (D-SC), is investigating allegations that the U.S. government's response to the pandemic was undermined for political reasons by the Trump administration.
November 14, 2021
2020 07 01 22 14 2802 Washington Dc Capitol 400
Home
Biden taps Califf to once again lead FDA as commissioner
Califf was a longtime professor at Duke University, where he earned his medical degree in 1978. He was vice president of clinical and translational research at Duke for 16 years; his most immediate position has been senior advisor at Verily Life Sciences and Google Health.NEW: This morning @califf001 will be announced as the new FDA Commissioner.No other choice brings both continuity & exciting new direction at such an important time.
November 11, 2021
2021 11 12 18 02 7119 Califf Robert 20211112183706
Microbiology
LabPulse.com Microbiology Insider
Dear Microbiology Insider,
August 31, 2021
Sequencing
Illumina completes Grail deal, despite lack of European approval
Illumina announced its intent to acquire Grail in September 2020 for $8 billion in cash and stock. The deal would unite Illumina's core expertise in next-generation sequencing (NGS) with Grail's diagnostic portfolio, specifically the Galleri test for more than 50 types of cancer. The deal reunites Grail with Illumina, which spun off Grail four years ago.
August 17, 2021
2020 01 09 22 46 7361 Business Deal Corporate 400
Infectious
With Hitachi deal done, Fujifilm sets sights on healthcare growth
The company's European business will be known as Fujifilm Healthcare Europe, while the U.S. unit has been renamed as Fujifilm Healthcare Americas. The new business will offer a complete line of medical products representing both Fujifilm and Hitachi portfolios.
July 1, 2021
2021 03 18 23 58 5869 Fujifilm Rsna 2019 400
FDA Warning Letter
FDA puts kibosh on use of Innova Medical coronavirus test
In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
June 9, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
Pathology, histology
VA inquiry finds Ark. pathology chief made 3K errors
Levy was chief of pathology and laboratory medicine at Veterans Health Care System of the Ozarks in Fayetteville until he was terminated in 2018, two years after he had completed a substance abuse program that was ordered after he was accused of working under the influence of alcohol.
June 1, 2021
2021 06 02 20 19 9323 Business Computer Investigation Magnifying Glass 400
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Business Insights
Texas lab owner accused of $79M RPP fraud scheme
The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.
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Revvity broadens work in newborn testing for NHS England
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Regulatory Approval
Roche gets CE Mark for ovarian cancer CDx test
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Sequencing
AMP reviews pitfalls of NGS testing for SARS-CoV-2
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Caris Life Sciences embarks on 10K-sample breast cancer biomarker analysis project
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Caris will perform comprehensive molecular characterization of TAILORx tissue samples.
October 25, 2024
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ASCLS seeks support for med lab personnel act
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The proposed legislation includes loan repayment provisions and requires $25 million in the first year.
October 25, 2024
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Pathology groups' antitrust legal fight heats up
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A lawsuit in which Iowa pathologists are suing their former colleagues is escalating, with one side accusing the other of attempting to maintain a monopoly at the expense of patients.
October 24, 2024
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Mobile lab, owners to pay $135K to settle Medicare fraud case
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A California mobile phlebotomy operation and its owners will collectively pay $135,000 to resolve alleged fraud and Anti-Kickback Statute violations.
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Payer consolidation raises red flags for diagnostic testing, pathology leaders
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A new report from the U.S. Department of Health and Human Services Office of the Inspector General shows that Medicare administrative contractors do not always comply with Medicare payment policies.
October 23, 2024
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