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MGI Tech and Yeasen reached a strategic cooperation
2023-03-13
On March 10, 2023, Shenzhen MGI Tech Co.,Ltd. and Yeasen Biotechnology (Shanghai) Co., Ltd. officially reached a strategic cooperation to promote the localization of high-throughput sequencing (NGS) reagents and instruments in China.
Agilent Technologies, Proscia ink digital pathology distribution agreement distribution agreement
2023-03-13
Agilent Technologies announced a multiyear distribution agreement with Proscia to offer a comprehensive digital diagnostic pathology system.
Virax to supply AIV real-time PCR test kit in EU
2023-03-13
Virax Biolabs Group has reached an agreement for the supply of an Avian Influenza A Virus (AIV) real-time PCR test kit in the European Union (EU) region, or CE mark-accepting markets.
How LDT can help the development of in vitro diagnostic industry in China as the pilot for medical institutions to expand the self-developed reagents?
2023-03-10
In October 2022, the Office of the Leading Group for Deepening Medical and Health System Reform in Shanghai issued the Notice on Piloting the High-Quality Development of Public Hospitals in Shanghai.
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.
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