Chinese molecular diagnostics and precision medicine firm GenePlus Technology said on Sunday that it has filed for an initial public offering on the Hong Kong Stock Exchange.
Singlera Genomics said on Tuesday that it has entered into a research and distribution agreement with EU-based international medical company Pure Medical for its cell-free DNA detection products.
Zydus Lifesciences said on Friday that it has signed an agreement to exclusively commercialize a trio of Myriad Genetics cancer tests in India.
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.
Results of a Phase I clinical trial published on Tuesday demonstrate that Personalis' minimal residual disease (MRD) assay, NeXT Personal, accurately predicts immunotherapy response across multiple metastatic solid tumor cancer types.
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.
The US Food and Drug Administration's recent proposal to reclassify companion diagnostic assays as Class Il devices may lead to additional opportunities for diagnostic test manufacturers, diagnostic industry stakeholders claim.
Diagnostics firm TrilliumBio said Tuesday that it is collaborating with Oncobit to offer the Swiss company's uveal melanoma monitoring assay in the US.
Molecular diagnostics firm BillionToOne reported after the close of the market on Tuesday that its Q3 2025 revenues more than doubled year over year.
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