Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer.

bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® VITAMIN B12 TOTAL, an automated quantitative test for use on the VIDAS® immunoassay instruments, for the measurement of total Vitamin B12 concentration in human serum or plasma.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that its AISightⓇ Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis. The CE mark paves the way for the company's expansion in the European diagnostic pathology market, enhancing pathologists' interpretations and driving efficiencies and quality improvements within anatomic pathology laboratories.

Switzerland's Saphetor said Wednesday that it has received CE marking for VarSome Clinical, its genome interpretation platform.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the CE Mark for its Accu-Chek SmartGuide® continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cobas c 703 and cobas ISE neo analytical units offer cutting-edge features to help address some of the key challenges faced by diagnostic laboratories worldwide such as shortage of qualified staff and space limitations.

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

Siemens Healthineers said on Monday that the firm has received CE marking for a prognostic blood test that the firm plans to launch later this year in Europe to aid the management of multiple sclerosis.