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BioMérieux Gets FDA 510(k) Clearance, CLIA Waiver for Respiratory, Throat Infection PCR Test
2024-03-28
French diagnostics firm BioMérieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.
Bio-Techne Receives IVDR Certification for Chronic Myeloid Leukemia Test
2024-03-27
Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients.
Court adviser sides with Illumina in EU row that triggered Grail fine
2024-03-27
Illumina may avoid an approximately 432 million euro fine related to its Grail takeover after an adviser to the Court of Justice of the European Union (ECJ) ruled in its favor Thursday.
QIAGEN introduces QIAstat-Dx Analyzer 2.0 with remote test results access, enhancing collaboration across healthcare system
2024-03-26
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the release of the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade, a significant enhancement to the widely-used QIAstat-Dx Analyzer 1.0 for reliable, fast and cost-effective diagnosis of complex syndromes.
Roche Malaria Test Receives FDA Approval
2024-03-26
The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency.
Thermo Fisher, Bayer partner to develop companion diagnostics
2024-03-25
Thermo Fisher Scientific said Wednesday that it has partnered with Bayer to develop companion diagnostic assays for the drugmaker’s precision cancer therapies.
WHO Publishes New Guidance Recommending Targeted NGS for Drug-Resistant TB Diagnosis
2024-03-25
The World Health Organization has published updated guidelines for the rapid diagnosis of tuberculosis, including new recommendations on the use of targeted next-generation sequencing (NGS) tests for drug-resistant TB.
C₂N Diagnostics, LLC Announces Investment From Eisai Inc.
2024-03-08
C₂N Diagnostics, LLC, a leader in advanced brain health diagnostics, and Eisai Inc., a “human health care company,” have announced Eisai has made an investment of up to 15 million USD in C₂N.
QuidelOrtho Gets Health Canada Approval for Triage Preeclampsia Test
2024-03-08
QuidelOrtho announced Wednesday that it has received approval from Health Canada to market the firm's Triage PLGF test. The test detects a biomarker that can indicate the likelihood of a pregnant person developing preterm preeclampsia.
Technoclone Nabs FDA De Novo Authorization for ADAMTS13 Assay
2024-03-07
Diagnostic test maker Technoclone on Tuesday said it has secured US Food and Drug Administration de novo marketing authorization for a test that is used to aid the diagnosis of a rare, life-threatening blood-clotting disorder.
Invitae Reports Estimated Unaudited Fourth Quarter and Full Year 2023 Financial Results
2024-03-07
Invitae (OTC: NVTA), a leading medical genetics company, today announced estimated unaudited fourth quarter and full year 2023 revenue, gross profit and cash burn.
Fujirebio Europe Picks up Distribution Rights to Self-screen's RUO Anal Cancer Assay
2024-03-06
Fujirebio Europe has acquired the nonexclusive distribution rights to Self-screen's PreCursor-M AnoGyn assay in Europe, the Middle East, Africa, and Asia, the companies said on Tuesday.
Beckman Coulter Life Sciences Flow Cytometer Nabs FDA 510(k) Clearancea
2024-03-06
Danaher subsidiary Beckman Coulter Life Sciences announced Tuesday that its DxFlex Clinical Flow Cytometer has received 510(k) clearance from the US Food and Drug Administration.
Traffic Guide for Visiting CACLP & CISCE 2024 in Chongqing, China
2024-03-06
To ensure a smooth and hassle-free experience during your visit, we have prepared this traffic guide to help you navigate the transportation options available in the area.
Diasorin’s LIAISON PLEX platform and assay receive FDA clearance
2024-03-05
DiaSorin has received the US Food and Drug Administration’s 510(k) clearance for its LIAISON PLEX platform and the accompanying LIAISON PLEX Respiratory flex assay.
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