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Policy and Regulation
FDA said no to proficiency testing for LDT quality
By
Liz Carey
Inferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.
May 2, 2024
Leica Biosystems, Sectra receive FDA 510(k) clearance for digital pathology system
By
LabPulse.com staff writers
Leica Biosystems has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aperio GT 450 DX digital pathology system, in conjunction with Sectra's digital pathology software.
May 2, 2024
FDA releases LDT final rule
By
Liz Carey
The FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.
April 29, 2024
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
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
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
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
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
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
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
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
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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