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.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, a state-of-the-art multi-modality breast biopsy system designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease.

The EU's Unified Patent Court last week ruled in favor of Myriad Genetics in its patent dispute with South Korean firm GXD-Bio.

Guardant Health Japan said Monday that it has received approval from that country's Ministry of Health, Labour, and Welfare (MHLW) for its Guardant360 CDx as a companion diagnostic for identifying ESR1 mutations in breast cancer patients.

Exact Sciences is building evidence on the ability of its Oncodetect minimal residual disease (MRD) test to determine the risk of distant recurrence in breast cancer patients in the hopes of expanding its adoption and reimbursement in this setting.

Roche said Monday that the US Food and Drug Administration has approved the company's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests, clearing them for identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with AstraZeneca's Enhertu (trastuzumab deruxtecan).

Natera said Friday that it is collaborating with oncology research firm Medica Scientia Innovation Research (MEDSIR) on the MiRaDoR breast cancer trial for hormone receptor-positive, HER2-negative breast cancer.

Myriad Genetics, Clairity, and MagView said on 25 Nov that they have integrated their products to improve personalized breast cancer risk assessment.

Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE IVDR approval for two label expansions for its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.