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The US Food and Drug Administration said on Wednesday that it will consider Emergency Use Authorization submissions for SARS-CoV-2 variant genotyping assays.2021-12-16View More
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Quest Diagnostics said on Tuesday that it has acquired substantially all of the assets of LabTech Diagnostics.2021-12-16View More
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On December 14, Beijing Hotgen Biotech Co., Ltd. announced that the company intends to acquire 38.0993% equity interest in Oriomics by way of equity transfer and subscription of additional registered capital at a price of CNY 153 million.2021-12-15View More
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In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report.2021-12-15View More
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Canadian precision medicine lab services provider CellCarta has acquired Belgian genomic testing solutions firm Biogazelle. Financial terms of the acquisition were not disclosed.2021-12-15View More
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Fluorescence light microscopy has the unique ability to observe cellular processes over a scale that bridges four orders of magnitude. Yet, its application to living cells is fundamentally limited by the very rapid and unceasing movement of molecules that define its living state.2021-12-14View More
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Baxter International Inc. (NYSE:BAX), a global medtech leader, announced today it has completed its acquisition of Hillrom. Baxter paid $156.00 in cash for each outstanding share of Hillrom common stock for a purchase price of $10.5 billion (based on Hillrom share counts at closing).2021-12-14View More
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Recently, Autobio's thyroid functional magnetic particle chemiluminescence series reagents obtained the EU IVDR CE certification issued by T¨¹V S¨¹D. This is the first series of Autobio¡¯s products to obtain the EU IVDR CE certification.2021-12-14View More
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The US Food and Drug Administration released a notice on Thursday that Meridian Biosciences' Revogene SARS-CoV-2 test is unlikely to be able to detect the Omicron variant.2021-12-13View More
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Qiagen and Denovo Biopharma said on Thursday that they are collaborating to develop a blood-based companion diagnostic test to identify patients expressing a genomic biomarker who are likely to respond to Denovo's investigational DB102 treatment for diffuse large B-cell lymphoma.2021-12-13View More
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Tumors are heterogeneous, which means that different parts of the same tumor can be genetically distinct. This phenomenon, known as intratumor heterogeneity, is steadily gaining in significance within the field of cancer research.2021-12-13View More
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On December 8, Roche Diagnostics China (hereinafter referred to as "Roche") and SHAPHAR announced the opening of a new round of strategic cooperation.2021-12-10View More
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A potentially game-changing Antigen Rapid Test (ART) technology to diagnose COVID-19 has been developed by scientists in Singapore.2021-12-10View More
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Thermo Fisher Scientific said on Thursday that the US Food and Drug Administration has granted premarket approval to the company's Oncomine Dx Target Test as a companion diagnostic for Janssen Biotech's targeted lung cancer treatment amivantamab-vmjw (Rybrevant).2021-12-10View More
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Dec. 8, 2021 -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion.2021-12-09View More
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UK molecular diagnostics company Genedrive said on Wednesday that its rapid molecular COVID-19 test has received CE marking.2021-12-09View More
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To date, CRISPR enzymes have been used to edit the genomes of one type of cell at a time: They cut, delete or add genes to a specific kind of cell within a tissue or organ, for example, or to one kind of microbe growing in a test tube.2021-12-09View More
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Since December 2019, the epidemic has raged all over the world. Affected by the epidemic, more than 1,400 China in vitro diagnostic companies are facing severe challenges. As of the end of November, 24 IVD-related companies have been successfully listed during the epidemic.2021-12-09View More
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Zhejiang Orient Gene Biotech Co.,Ltd. invested US$5 million in Scotland, UK to establish a wholly-owned subsidiary ACCUBIO.LIMITED.UK. BGI Genomics Co.,Ltd. s IVD factory in Ethiopia has passed the Medical device-Quality management system-requirements for regulatory (ISO 13485:2016) .2021-12-08View More
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FDA has granted another set of regulatory privileges under its breakthrough devices program. The latest batch is led by breakthrough designations for treatments of lung cancer and bone metastases that are in development at RefleXion Medical and Zetagen Therapeutics.2021-12-08View More
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