Current Headlines
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Labcorp Announces Acquisition Of Select Assets Of BioReference Health's Diagnostics Business
3/28/2024
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today that they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.
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Dual 510(K) Clearance And CLIA-waiver Approval For The BIOFIRE SPOTFIRE R/ST Panel
3/27/2024
bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel.
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Bostongene Recognized As Designated Laboratory For The ComboMATCH Precision Medicine Clinical Trial
3/26/2024
BostonGene, a leading provider of AI-driven, molecular and immune profiling solutions, today announced its participation in the Molecular Analysis for Combination Therapy Choice (ComboMATCH) precision medicine initiative as a designated laboratory.
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STEMCELL Technologies Announces FDA De Novo Classification For Its EasySep CD138 Positive Selection Kit To Support Cancer Diagnostic Tests
3/26/2024
STEMCELL Technologies is pleased to announce that its new EasySep Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
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FormaPath Announces The Novel Tissue Biopsy Grossing Platform: nToto™
3/26/2024
In conjunction with a poster presentation at the United States and Canada Association of Pathologists Annual (USCAP) meeting titled "Current State of Intra-/Interobserver Accuracy and Reproducibility in Tissue Biopsy Grossing and Comparison to an Automated Vision System" – Poster #198, FormaPath is pleased to announce nToto, a new automated tissue visualization system (ATVS) developed in collaboration with Mayo Clinic's Advanced Diagnostics Laboratory.
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Nucleus Genomics Launches To Bring Whole-Genome Sequencing To The Public
3/25/2024
Nucleus Genomics, the next-generation genetic testing and analysis company, today announced the launch of its DNA analysis product to bring the benefits of personalized medicine to everyone.
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Scientists Close In On TB Blood Test Which Could Detect Millions Of Silent Spreaders
3/22/2024
Scientists have taken a major step towards developing a blood test that could identify millions of people who spread tuberculosis unknowingly.
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FDA Clears RedDrop Dx, Inc.’s Blood Collection Device, RedDrop One
3/22/2024
RedDrop Dx, Inc., Innosphere Ventures Client Company, is pleased to announce that its innovative blood collection device, RedDrop One, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for prescription use.
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Bio-Techne Receives European Ivdr Certification For Diagnostic Test To Monitor Chronic Myeloid Leukemia
3/22/2024
Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit.
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CMS Designates The NavDx Test As An Advanced Diagnostic Laboratory Test (ADLT)
3/21/2024
Naveris, Inc., the leader in precision oncology diagnostics for viral-related cancers, today announced that the Centers for Medicare & Medicaid Services (CMS) has designated NavDx, the Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test that aids in the detection of HPV-driven cancer, as an Advanced Diagnostic Laboratory Test (ADLT).