A team led by researchers at the University of Michigan has developed and clinically validated an 18-gene urinary test for detecting high-grade prostate cancer.

BGI Genomics, a global leader in integrated precision medicine solutions, has established a new clinical laboratory at Uruguay's Parque de las Ciencias free trade zone. This facility is poised to become a regional hub, advancing preventive medicine across Latin America and utilizing advanced technology to facilitate early disease diagnosis.

The market for medical technology is innovative, dynamic, and growing. Bosch sees medical technology as a strategic growth field and intends to expand its Bosch Healthcare Solutions subsidiary, based in Waiblingen.

NanoString Technologies said on Wednesday after the close of the market that Bruker will acquire substantially all of its assets for approximately $392.6 million in cash. In addition, Bruker will assume certain liabilities from NanoString.

Abbott on Wednesday announced that its Q1 2024 Diagnostics revenues declined 18 percent year over year as a result of declining COVID-19 testing sales.

In April, the recent release of the 2024 medical device classification encompasses 223 results, including 93 products related to In Vitro Diagnostics (IVD). Among these, 27 IVD-related products are suggested for Class III medical device management, 45 for Class II, and 14 for Class I.

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.