Produced by AVE, it has a high degree of automation, and the front end is equipped with automatic sample delivery device.

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

The Association for Diagnostics & Laboratory Medicine (ADLM) 2026 Annual Meeting — Waters Corporation (NYSE: WAT) today announced the launch of the Xevo TQ Absolute XR IVD Mass Spectrometer, expanding its MassTrak™ IVD System portfolio of LC-MS/MS Systems with a solution that combines class-leading sensitivity and enhanced robustness for clinical applications. The new system builds on the industry-renowned step-change performance of the Xevo TQ Absolute IVD Mass Spectrometer, which established the benchmark for sensitivity among IVD-compliant tandem quadrupole mass spectrometers.

The U.S. FDA has approved Freenome's (FRNM.O), opens new tab blood-based colorectal cancer ​screening test for older adults, paving the way for partner ‌Abbott (ABT.N), opens new tab to launch it in the U.S. this fall, the companies said on Monday.

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

Ibex Medical Analytics (Ibex), the global leader in AI-powered pathology solutions for clinical diagnostics and biopharma, today announced that it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for Ibex Breast ER, PR and Ki67. This milestone solidifies Ibex’s position as the market leader in breast cancer diagnostics by rounding out regulatory approval for its entire breast portfolio, which delivers unprecedented value to pathologists, laboratories, and patients. Covering biopsies and excisions, the breast suite comprises a fully IVDR-certified, end-to-end workflow across H&E, HER2, ER, PR, and Ki67-stained whole slide images. This was achieved following clinical studies and a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the second quarter ended June 27, 2026.

Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.

OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its second generation OraQuick™ Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest.

NanoSomiX, Inc., a biotechnology company focused on blood‑based analytics using extracellular vesicles (EVs), including brain‑derived EVs, today announced plans to collaborate with Beckman Coulter Diagnostics, a global leader in clinical diagnostics, to explore the development of next‑generation immunoassays for neurodegenerative diseases.

Seegene, Inc. ("Seegene"), a global leader in molecular diagnostics, announced today that its U.S. subsidiary, Seegene USA, Inc. ("Seegene USA"), has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex™ HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.