On April 6, 2022 C2i Genomics, a cancer intelligence company, reported it has launched its C2inform minimal residual disease (MRD) test across Europe after obtaining CE-IVD marking in the EU and UK (Press release, C2i Genomics, APR 6, 2022, View Source [SID1234611639]). The company also announced the completion of several clinical trials across the globe, including leading cancer centers in Europe, U.S. and Singapore.

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The new clinical data will be presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans, Louisiana. 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.

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, monitor disease progression, and evaluate 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.

"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."

At the AACR (Free AACR Whitepaper) 2022, C2i will present exciting new clinical performance results of C2inform from clinical studies that include over 200 patients and 3,000 plasma samples from the EU, U.S. and Singapore. The studies have validated the C2inform assay performance on multiple early-stage cancer types including colorectal, bladder, glioblastoma multiforme (GBM) and lung cancer. More than half of these results were established in clinical studies in Europe.

The C2inform test is the first product released through the C2intelligence cloud-based platform. A globally deployed and highly scalable software-as-a-service (SaaS) platform for whole-genome data management, analytics and clinical interpretation. The platform is compatible with analyzed sequences received from any Illumina NovaSeq sequencer, increasing worldwide accessibility and reducing turnaround times and logistic barriers.

This CE Mark comes shortly after the company announced a strategic partnership with OncoDNA and the initiation of a first-of-its-kind interventional clinical trial in France led by Gustave Roussy. Outside of Europe, the company has multiple global alliances, including a partnership with NovogeneAIT Genomics in Southeast Asia and in China with a strategic partnership with NuProbe Global. The company also has a technology development partnership with Twist Bioscience and clinical data and genomics data integration with Premier Inc.

For companies interested in deploying the platform, please visit www.c2i-genomics.com.