Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Oncocyte announced on Thursday that it has partnered with Bio-Rad Laboratories to globally commercialize the research-use-only GraftAssure assay.

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced it has received approval of its divestment plan for GRAIL from the European Commission (EC).

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer’s disease on people and society.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

Bosch has entered into a strategic partnership with the laboratory and medical technology company Randox Laboratories Ltd. The two companies are investing around 150 million euros in joint research, development and sales activities. This will result in new tests for the Vivalytic analysis platform from Bosch Healthcare Solutions. One objective is the development of an IVD (in vitro diagnostics) high multiplex sepsis test, which is to be implemented for the first time on the basis of the innovative BioMEMS technology.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the approval of the CE Mark for the VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU® (trastuzumab deruxtecan) may be considered as a targeted treatment. The test, which is branded PATHWAY in the United States, received US Food and Drug Administration (FDA) approval in October 2022. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

BioMérieux reported on Tuesday that its first quarter revenues grew approximately 7 percent year over year driven by growth in BioFire and microbiology sales.

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, and Agilent Technologies, announce a collaboration to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.

BBI Solutions OEM Limited (BBI), the premier independent manufacturer of immunodiagnostic reagents globally, has announced the successful closing of the acquisition of IBEX Technologies Inc. (IBEX), a leading developer and manufacturer of high-precision enzymes and diagnostic solutions located in Montreal, Quebec. This acquisition strategically enhances BBI’s capabilities to support In Vitro Diagnostic (IVD) manufacturers with the growing global demand for IVD haemostasis testing, driven by an ageing population, the rising prevalence of chronic diseases, and an increased reliance on point-of-care tests in surgery and trauma settings. By incorporating IBEX’s innovative enzyme technologies into its extensive portfolio of recombinant proteins, BBI is also responding to the notable industry shift towards recombinantly produced reagents for IVD tests, reflecting a growing preference for more standardized and reliable testing methodologies.

Building on 80 years of expertise engineering cold storage lab equipment, Thermo Fisher Scientific today introduces its newest line of high performance, ultra-low temperature (ULT) freezers. With enhancements to performance, user experience and energy efficiency, the Thermo Scientific™ TSX™ Universal Series ULT Freezers seamlessly adapt to scientists’ workflows across a variety of lab settings, marking a new era in performance, reliability, and sustainability.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) a global leader of life science research and clinical diagnostics products, today announces a collaboration with Allegheny Health Network (AHN), a western Pennsylvania–based integrated healthcare system. This research collaboration aims to generate clinical evidence across a range of cancer types to support the implementation of Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology for tumor-informed molecular residual disease (MRD) monitoring of patients with solid tumor cancer following curative-intent treatment.

Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) and Siemens Healthcare Diagnostics Inc. (HQ: NY, U.S.A.) (“Siemens Healthineers”) announce that from April 2024, the companies have begun to distribute independently their combined portfolio of hemostasis testing solutions to laboratories in the United States and EU countries* under the companies’ respective brands based on a mutual OEM supply initiative. This distribution is based on a global OEM agreement on hemostasis products concluded in February 2023 (hereinafter, "Agreement"). Moving forward, we will gradually expand the implementation of sales through this initiative on a global scale.

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver. This achievement also reflects QuidelOrtho’s dedication to delivering effective testing solutions while highlighting ongoing efforts in research and development to enhance market competitiveness.

Agilent Technologies Inc. (NYSE: A) today announced the launch of the Advanced Dilution System, the ADS 2, a new automation workflow solution that will increase productivity, lower cost of ownership, and improve the overall efficiency within the laboratory.

Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

Oxford Nanopore Technologies has signed a partnership with artificial intelligence developer SeqOne to support its next-generation sequencing approach in clinical diagnostic testing.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today that they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.

Genetron Holdings Limited (“Genetron Health” or the “Company”, Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, announced today the completion of its merger (the “Merger”) with Genetron New Co Limited (“Merger Sub”), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the “Merger Agreement”), among the Company, New Genetron Holding Limited (“Parent”) and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company.