C2i Genomics, a cancer intelligence company, has launched 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 cancer centers in Europe, US and Singapore.
The new clinical data will be presented at the 2022 American Association for Cancer Research (AACR) annual meeting in New Orleans, Louisiana.
What is C2inform?
C2i Genomics says that 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 to offer testing closer to the patient.
The test works by applying whole-genome sequencing and artificial intelligence (AI) to a 3-4mL blood sample to support rapid and accurate detection of cancer, monitor disease progression, and evaluate therapeutic efficacy.
The test enables personalised treatment decisions and supports the development of more effective cancer treatments through pharma drug development partnerships. It requires 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.
The certification
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.
Official comments
“The last year has been incredibly exciting as we’ve solidified multiple global partnerships to expand our distributed diagnostic model. With several strategic partnerships throughout Europe and now with the CE mark registration, we’re eager to scale our C2inform test to bring whole genome cancer detection and monitoring across Europe,” said Asaf Zviran, CEO and Co-Founder of C2i Genomics. “As C2i continues to expand commercial availability our goal at our core is to continue advancing better patient outcomes and more precise oncology treatments.”