Johnson & Johnson's (JNJ.N), opens new tab first-quarter revenue missed Wall Street estimates for medical devices on Tuesday and sales of its blockbuster psoriasis drug Stelara came in lower than expected as the company prepares for its loss of exclusivity in the U.S.

Global life sciences company Labcorp has announced the first commercially available glial fibrillary acidic protein (GFAP) blood biomarker test in the US, offering a new tool for the early detection of neurodegenerative diseases and brain injuries.

Biochemical diagnosis is often used for the testing of basic items such as liver function, kidney function, blood glucose, and blood lipid. By measuring the content (activity) of specific biochemical substances, people's physical conditions can be assessed and the relevant causes can be identified.

Prenosis’ Sepsis Immunoscore software analyzes 22 parameters such as respiratory rate and blood pressure to assess the likelihood that a patient will develop sepsis within 24 hours. Companies including Epic Systems, a leading provider of electronic health records, have developed software for assessing sepsis risk, but Prenosis broke new ground with its recent de novo authorization.

Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification. This certification demonstrates that the assay meets the higher standards established by IVDR. It ensures the continued availability of this trusted qualitative assay to clinical geneticists and other healthcare professionals throughout the EU.

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.