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Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime¡¯s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.2024-01-02View More
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Swiss drugmaker Roche (ROG.S) said on Friday it has agreed to buy LumiraDx's (LMDX.O) Point of Care diagnostics platform business for about $295 million.2024-01-02View More
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In 2023, China Chamber of Commerce of Medical & Health Products Importers & Exporters (CCCMHPIE) successively announced three batches of export brand certificates for companies recommended by CCCMHPIE in FY2023.2023-12-28View More
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Bruker has entered into an agreement with private equity firm PAI Partners to purchase EliTechGroup, PAI announced on Wednesday.2023-12-28View More
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Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of POINT Biopharma Global Inc. (NASDAQ: PNT), a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.2023-12-28View More
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Up to now, the total number of domestic Class II & III medical device product registrations within the validity period in China has reached 114,626.2023-12-27View More
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Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.2023-12-26View More
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By rapid development of China's immunoassay, the market share of chemiluminescence has gradually expanded. Immunoassay diagnosis was already the largest sub-field of the market in China, currently accounting for about 25%.2023-12-25View More
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The Egyptian Drug Authority (EDA) and Roche, global leader in pharmaceuticals and diagnostic solutions have signed a Memorandum of Understanding (MOU) to shape the regulatory environment and undergo digital transformation.2023-12-25View More
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H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.2023-12-25View More
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Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.2023-12-22View More
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Enable Biosciences said on Tuesday that it has received a $3 million Phase IIB Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases for its type 1 diabetes test.2023-12-22View More
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The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).2023-12-21View More
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QuidelOrtho Corporation (Nasdaq: QDEL) (¡°QuidelOrtho¡±), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.2023-12-21View More
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CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.2023-12-21View More
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Owkin announced on Tuesday that it entered into a collaboration with MSD ¡ª known as Merck in the US and Canada ¡ª to develop and commercialize microsatellite instability high (MSI-H) diagnostics for four types of cancer.2023-12-20View More
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Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.2023-12-20View More
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The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years.2023-12-19View More
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Euroimmun, a Revvity company, and Xpedite Diagnostics have partnered to offer DNA extraction protocols for point-of-care diagnostics.2023-12-19View More
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Today, Illumina, Inc. (NASDAQ: ILMN) announced that the company will divest GRAIL.2023-12-19View More
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