What You Should Know:
– C2i Genomics, a cancer intelligence company launches its C2inform minimal residual disease (MRD) test across Europe, after obtaining CE-IVD marking in the EU, UK and Switzerland. The company also announced the completion of several clinical trials across the globe, including leading cancer centers in Europe, U.S. and Singapore.
– The new clinical data will be presented at the 2022 American Association for Cancer Research (AACR) annual meeting in New Orleans, Louisiana next week. C2inform is the first CE Marked software-as-a-medical-device MRD test and will be available in countries accepting the CE Mark. The test provides a streamlined process for in-house use by any pathology lab and genomic cancer lab so that testing can be offered closer to the patient.
How It Works
C2inform test works by applying whole-genome sequencing and artificial intelligence to just a 3-4mL blood sample to support rapid and accurate detection of cancer, monitoring of disease progression and evaluation of therapeutic efficacy. The test enables informed and timely personalized treatment decisions and supports the development of more effective cancer treatments through pharma drug development partnerships. The test requires significantly reduced lab operation complexity, eliminates the need to develop a patient-specific assay, and offers a rapid and high throughput solution for cancer patients across the EU.
This European regulatory certification indicates C2inform’s conformity with high safety, health, and environmental protection standards and allows for commercial sale to cancer diagnostic labs that require CE Marking. The CE Mark is a prerequisite for reimbursement of diagnostic tests by health authorities, and in some European countries, it is required before laboratories can use a new testing method. Early adopters include multiple leading cancer centers in Denmark, Switzerland, France and UK, and an industry partnership with OncoDNA, a genomic and theranostic company that was announced as a strategic partner of C2i Genomics in early 2022.