CC2i Genomics has introduced its minimal residual disease (MRD) test, C2inform, to bring cancer monitoring to centres in Europe.
The latest move comes after the company secured CE-IVD marking for the test in the EU and UK.
The company will make the software-as-a-medical-device MRD test available in countries that accept the CE Mark.
C2inform provides a streamlined process for in-house use by any genomic cancer lab or pathology lab to offer patient testing.
C2i Genomics CEO and co-founder Asaf Zviran said: “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.
“As C2i continues to expand commercial availability our goal at our core is to continue advancing better patient outcomes and more precise oncology treatments.”
With the application of whole-genome sequencing and artificial intelligence to a blood sample of 3ml to 4ml, C2inform will support rapid and accurate cancer detection.
The test will also support monitoring of disease progression and evaluation of therapeutic efficacy, enabling informed personalised treatment decisions.
Furthermore, through pharma drug development collaborations, it supports effective cancer treatments development.
Needing reduced lab operation complexity, C2inform eliminates the need for patient-specific assay development and offers a rapid solution for cancer patients in the EU.
Additionally, C2i Genomics concluded several clinical trials of the C2inform test worldwide, including at cancer centres in Europe, Singapore and the US.
The trials included more than 200 patients and 3,000 plasma samples from these regions and validated the performance of the C2inform assay on multiple cancer types in the early stages. These included colorectal, bladder, glioblastoma multiforme and lung cancer.