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The US Food and Drug Administration has granted Emergency Use Authorization to Healgen Scientific for a point-of-care combination antigen test for COVID-19 and influenza A/B.2024-06-17View More
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Roche announced this week that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients.2024-06-17View More
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Challenge Works said Wednesday that it has awarded an £8 million prize to Sweden's Sysmex Astrego for its development of a point-of-care urinary tract infection test that delivers antibiotic susceptibility information in 45 minutes.2024-06-14View More
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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the release of a new version of its clinical decision support software, QIAGEN Clinical Insight Interpret (QCI Interpret), that brings significant performance and scalability enhancements tailored for high-throughput, next-generation sequencing (NGS) labs moving to larger test panels and higher test volumes. The latest version of QCI Interpret introduces improvements that accelerate critical lab performance criteria for turn-around-time, diagnostic yield and quality results.2024-06-14View More
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Myriad Genetics announced Tuesday that GlaxoSmithKline is sponsoring a program to boost access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients in nine countries via Myriad's MyChoice HRD Plus and MyChoice CDx Plus tests.2024-06-13View More
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Foundation Medicine, Inc., today announced that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare¡¯s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations. The companies are also exploring opportunities to develop FoundationOne®CDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.2024-06-13View More
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The 26th International Congress of Clinical Chemistry and Laboratory Medicine - IFCC WorldLab Congress organized jointly with the 17th Congress of the Arab Federation of Clinical Biology, 10th Annual Meeting of the Saudi Society for Clinical Chemistry and 8th International and United Arab Emirates Genetic Disorders Conference successfully convened in Dubai from 26-30 May 2024.2024-06-12View More
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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of 35 new wet-lab tested digital PCR Microbial DNA Detection Assays for its digital PCR (dPCR) platform QIAcuity, significantly enhancing its offerings in the field of microbial research. The new assays are available on QIAGEN¡¯s comprehensive research platform GeneGlobe and are designed to target a wide range of pathogens responsible for tropical diseases, sexually transmitted infections (STIs) and urinary tract infections (UTIs), further solidifying QIAGEN's position as a leader in microbial detection and analysis.2024-06-12View More
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Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced that it has completed its previously announced acquisition of PathAI Diagnostics from PathAI, with the goal to accelerate the adoption of AI and digital pathology to improve the diagnosis of cancer and other diseases.2024-06-12View More
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Zybio obtained the registration certificate and patent for the Lp-PLA2 assay kit (rate method) in 2015. The performance of the kit can reach the international leading level by using an innovative substrate design and reagent formula.2024-06-11View More
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Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems ¨C Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2. The newly cleared systems have been intentionally designed to meet different needs ¨C Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.2024-06-11View More
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).2024-06-11View More
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The Association for Molecular Pathology on Thursday published a new set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing.2024-06-07View More
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DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced an equity investment by the Merck Global Health Innovation Fund (GHIF), the corporate venture capital arm of Merck & Co., Inc, known as MSD outside the United States and Canada. The capital will accelerate and expand DELFI's development and commercialization of its cancer detection solutions. DELFI's fragmentomics technology applies artificial intelligence (AI) to whole-genome sequencing data to compare an individual's cell-free DNA (cfDNA) patterns and characteristics against populations with and without cancer.2024-06-07View More
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Diasorin today announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company¡¯s new LIAISON PLEX® Yeast Blood Culture (BCY) Assay, the second molecular multiplexing panel on the LIAISON PLEX® system.2024-06-06View More
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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways. The new advancements aim to support customers with a wide range of assay customization options, from simple to complex and validated multiplex assays, while further improving the user experience.2024-06-06View More
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ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.2024-06-05View More
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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Edwards Lifesciences (NYSE: EW), today announced a definitive agreement under which BD will acquire Edwards' Critical Care product group ("Critical Care"), a global leader in advanced monitoring solutions, for $4.2 billion in cash, unlocking new value creation opportunities and enhancing BD's portfolio of smart connected care solutions.2024-06-05View More
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Maccura obtained the registration certificate of this product and was granted the invention patent in 2018. It is the first creatinine assay kit for anti-drug interference.2024-06-04View More
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Watmind USA has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its SpeedySwab Covid + FLU A&B Self-Test.2024-06-04View More
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