Policy and Regulation

Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
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Roche, Lilly Alzheimer's blood test granted FDA breakthrough device designation
By LabPulse.com staff writers
The Alzheimer's blood test developed through a collaboration between Roche and Lilly has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
April 11, 2024
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European Commission approves Illumina's plan to divest Grail
By LabPulse.com staff writers
The European Commission has approved Illumina's plan to divest multicancer early detection test maker Grail under the European Union Merger Regulation adopted by the EC in October 2023.
April 12, 2024
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Roche's breast cancer CDx receives CE Mark
By LabPulse.com staff writers
Roche has received the CE Mark for the first companion diagnostic (CDx) test to identify patients with HER2-low metastatic breast cancer who may be eligible for treatment with Enhertu.
April 10, 2024
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Prenosis gets FDA authorization for AI-based sepsis diagnostic tool
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization to artificial intelligence (AI) healthcare firm Prenosis' AI-based ImmunoScore sepsis risk-assessment software.
April 8, 2024
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Basilea gets FDA approval for antibiotic
By LabPulse.com staff writers
Swiss pharmaceutical manufacturer Basilea has received U.S. Food and Drug Administration (FDA) approval for its antibiotic Zevtera (ceftobiprole) for three different types of infections.
April 4, 2024
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BioMérieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By LabPulse.com staff writers
BioMérieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
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Bio-Techne receives IVDR certification for chronic myeloid leukemia monitoring test
By LabPulse.com staff writers
Bio-Techne has announced that Asuragen, part of its molecular diagnostics division, has completed class C certification under the new European Union IVDR for its QuantideX qPCR BCR-ABL IS kit for monitoring chronic myeloid leukemia.
March 22, 2024
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Highlights of March 2024 LDT hearing with lawmakers
By Liz Carey
The VALID Act appeared to win hearts over the hammer of a forthcoming FDA final rule expected to drop heavy regulations on clinical laboratory developed tests (LDTs), a hearing of the House Subcommittee on Health revealed Thursday.
March 22, 2024
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WHO launches new guidance on TB diagnostics
By LabPulse.com staff writers
The World Health Organization has published updated guidance for the diagnosis of tuberculosis (TB), including new recommendations on the use of next-generation sequencing for the diagnosis of drug-resistant TB.
March 21, 2024
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FDA updates draft guidance for Alzheimer's drug development biomarkers
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has released an updated draft guidance for the use of biomarkers aimed at sponsors and pharmaceutical companies developing drugs intended to treat early Alzheimer's disease.
March 14, 2024
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Bluebird Bio signs state Medicaid agreement for SCD gene therapy
By LabPulse.com staff writers
Bluebird Bio has signed its first outcomes-based Medicaid agreement for its sickle-cell disease (SCD) gene therapy Lyfgenia with the state of Michigan.
March 11, 2024
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