Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the global launch of the VENTANA® BAP1 (SP527)* test. This automated, ready-to-use immunohistochemistry (IHC) assay provides a reliable, highly specific diagnostic tool to help clinicians and pathologists accurately identify mesothelioma and distinguish it from other malignancies, including non-small cell lung cancer (NSCLC). The BAP1 assay is registered as a Class I IVD with the U.S. Food and Drug Administration, has received IVDR approval as a Class C device, and is available globally.

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has announced the launch of a 510(k) cleared rapid test to detect COVID-19 and Flu A&B in professional healthcare settings.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received the CE Mark for its cobas smart e immunoanalyser, a compact, standalone platform engineered to deliver reliable testing with a planned menu of over 100 high-medical-value assays. As the latest offering in Roche’s industry-leading cobas immunoassay systems portfolio, the platform bridges critical operational gaps across health systems by fitting central-laboratory precision into a footprint under one square meter. This enables decentralised sites to manage diverse testing demands directly in-house. With reaction times of 18 minutes or less across more than 90% of Roche immunoassays, local facilities can help reduce diagnostic turnaround times.

Labcorp (NYSE: LH), a global leader in innovative and comprehensive laboratory services, and Millennium Health, an accredited specialty laboratory with more than 15 years of experience in drug testing and surveillance, today announced that they have entered into a definitive agreement for Labcorp to acquire Millennium Health.

bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel has received Dual 510(k) Clearance and CLIA Waiver* from the U.S. Food and Drug Administration (FDA). This automated, multiplex polymerase chain reaction (PCR) test can simultaneously detect the most common causes of vaginitis in about 20 minutes, directly at the point of care on the BIOFIRE® SPOTFIRE® System, bringing rapid and accurate diagnostics closer to patients.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) (“QIAGEN” or the “Company”) and the EQT XI fund (“EQT Private Equity”) today announced an agreement under which Crown NL Bidco B.V. (the “Bidder”) announced its decision to make an all-cash voluntary public takeover offer for the acquisition of all outstanding QIAGEN shares at €46.50 per share (the “Takeover Offer”).

It is a modular urinalysis workflow launched by DIRUI, which can meet the realistic needs of clinical laboratories for automated and high-throughput urine testing.

Agilent Technologies Inc. (NYSE: A) today announced it has entered into a definitive agreement to acquire Proscia®, a provider of digital pathology software for clinical and life-sciences customers, in an all-cash transaction valued at $240 million in cash at closing and up to an additional $30 million based on achieving future performance milestones.

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

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.