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QIAGEN and Servier Partner to Develop Companion Diagnostic for Acute Myeloid Leukemia (AML) Therapy Drug
2023-03-10
QIAGEN announced it has entered into a strategic partnership with Servier, a global pharmaceutical group, to develop a companion diagnostic test for TIBSOVO®, an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of the blood cancer acute myeloid leukemia (AML).
Siemens Healthineers, Sysmex Ink Hemostasis Supply Agreement
2023-03-10
Japanese healthcare firm Sysmex said that it has signed a global supply agreement for hemostasis instruments and reagents with Siemens Healthineers.
BioMérieux Q4 Revenues up 11 Percent
2023-03-09
BioMérieux reported Wednesday that its fourth quarter revenues rose 11 percent year over year.
QuidelOrtho Receives De Novo FDA Authorization for Sofia® 2 SARS Antigen+ FIA
2023-03-09
QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).
With growing optimism about the market, multinational medical enterprises like Roche have invested over 4 billion yuan in China
2023-03-08
Recently, executives from multinational medical enterprises intensively visited China or revealed their plans to visit China. It is becoming a common question for most multinational medical businesses to explore how to support China's high-level opening up.
Spectrum Solutions Acquires Alimetrix, Inc. and Microarrays, Inc. to Expand Laboratory Products and Testing Capabilities
2023-03-08
Spectrum Solutions® announced the acquisitions of Alimetrix, Inc., a CLIA and CAP accredited molecular diagnostic laboratory, and Microarrays, Inc., a leader in customer array-based products that are used as biological research tools.
Abbott Gains FDA Clearance for Lab-Based TBI Test
2023-03-08
Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration.
Ramping up microfluidic chip production! TinkerBio Completed Tens of Millions of RMB Series A+ Financing
2023-03-07
TinkerBio completed a Series A+ financing round of tens of millions of RMB, exclusively invested by Panlin Capital.
MGI Tech Gets CE Mark for DNBSeq-G99 Sequencer Under New EU IVDR Framework
2023-03-07
MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).
Roche Nabs FDA Approval for Ventana PD-L1 Test as CDx for Libtayo
2023-03-07
Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.
FDA Breakthrough Device v.s. NMPA Innovative Medical Device
2023-03-06
Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.
FDA Grants Marketing Rights for InBios Point-of-Care Anthrax Test
2023-03-06
The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.
BGI Genomics Gets Australian Regulatory Approval for Multiplexed SARS-CoV-2, Influenza Test
2023-03-06
BGI Genomics said on Friday that its multiplexed test for SARS-CoV-2, influenza A, and influenza B is now included in the Australian Register of Therapeutic Goods.
Sansure collaborated with Singlera to enter the 100 billion CNY tumor early-screening market!
2023-03-03
Recently, Sansure and Singlera jointly established Jiangsu Yang Shengyuan Biotechnology Co., Ltd. with the registered capital of 10 million CNY at Yangzhou City.
Illumina, Myriad Genetics Expand Partnership to Bring TSO 500 HRD Assay to US
2023-03-03
Illumina and Myriad Genetics said on Thursday that they have expanded their strategic partnership on homologous recombination deficiency (HRD) testing.
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