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.

Paige, a leader in next-generation AI technology, and the Breast International Group (BIG), a leading international non-profit organization dedicated to breast cancer research, today announced a new partnership to conduct collaborative research aimed at improving breast cancer diagnosis, treatment, and patient outcomes.

Dutch diagnostics firm MRC Holland said this week that five of its blood-based tests for hereditary breast and ovarian cancer (HBOC) syndrome have received certification under Europe's In Vitro Diagnostic Regulation (IVDR).