Milestone CE marking for Oncobit first product

Swiss medtech Oncobit has just obtained CE marking for its first product. The University of Zurich spin-off led by Claudia Scheckel, develops precision diagnostic and monitoring assays for personalized cancer care.

Oncobit has CE marked its first product to enable personalized cancer care. OncobitTM PM BRAFV600 allows the sensitive and specific detection of BRAFV600 mutations in the patient’s blood over time and can be utilized for the monitoring of treatment response, minimal residual disease, and disease recurrence of melanoma. Oncobit’s IVD-system consists of a digital PCR assay and a software to analyze and interpret the generated data. The product is reimbursed in Switzerland and Oncobit is currently in discussions with multiple Swiss hospitals to offer this novel personalized monitoring solution to their patients.

CEO Claudia Scheckel, on announcing CE marking of Oncobit’s first product: “Using the digital PCR technology in combination with an in-house developed software allows us to detect individual cancer markers in the patient’s blood in a more sensitive and specific manner compared to existing solutions and will revolutionize the monitoring of melanoma patients.”

Providing detailed understanding of genomic cancer alterations

Oncobit is a MedTech spin-off from the University of Zurich, developing precision diagnostic and monitoring assays for personalized cancer care. Oncobit’s products aim to provide a detailed understanding of genomic cancer alterations throughout the patient’s treatment history. Highly sensitive diagnostic and monitoring tools allow Oncobit to propose the most relevant treatment options and to help physicians improve the therapies they provide their patients. Oncobit is addressing the rapidly expanding market of precision oncology and personalized disease monitoring with non-invasive and highly precise technologies. The company is currently focused on melanoma, but Oncobit’s approach is data-centric, modular, and expandable to other cancer types in the future. Oncobit has obtained ISO13485 certification for the design, development, and manufacturing of in vitro diagnostics in March 2022.

(Press release / ES)