Even after a tumor has been removed and a patient is in remission, tiny traces of cancer can still remain in the bloodstream. Without knowing just how many of those cells remain, oncologists may under- or overprescribe follow-up rounds of chemotherapy and radiation.
A blood test from C2i Genomics, however, aims to prevent those errors by quantifying the minimal residual disease, or MRD, left behind in cancer patients after surgery. The C2inform test has received CE mark clearance, the company announced this week, and its launch throughout the E.U. and U.K. has already begun.
Several cancer centers in Denmark, Switzerland, France and the U.K. have already added the test to their cancer treatment slates, and C2i will be able to quickly ramp up its European launch through a recent partnership that designated molecular profiling company OncoDNA as its primary lab partner on the continent.
The certification for the C2inform software-as-a-medical-device MRD test follows competitor NeoGenomics' announcement in January that it too had received a CE mark for its RaDaR liquid biopsy, which also tests for minimal residual disease using genomic sequencing.
The C2inform test requires just three or four milliliters of blood. The sample is processed by the New York-based company’s C2intelligence software, a cloud-based platform that performs whole-genome sequencing and applies artificial intelligence to analyze the results.
C2inform’s abilities have been proven in a handful of clinical studies, including a recently completed one slated to be presented at a conference this month that proved the test could accurately identify minuscule fractions of tumors in patients with stage 3 colorectal cancer. Other studies have backed up the test’s sensitivity and specificity in even more types of cancer, including bladder, glioblastoma and lung cancer.
The test’s findings can be used not only to detect lasting signs of cancer but also to keep track of its progression and monitor how well various treatments are working. Because it can be run in any pathology lab, uses standard genomic sequencing equipment and doesn’t need to be individually adapted for each patient’s form of cancer, C2i is envisioning the test being widely and rapidly used by cancer patients across Europe and, eventually, around the globe.
The company’s work to continue developing the C2inform test and C2intelligence platform and begin launching the former throughout the E.U. has been backed by the more than $112 million in venture funding that it’s raised in the three years since it was founded.
The latest—and by far the largest—influx of funding arrived in April 2021, when Casdin Capital led a two-tranche financing round that totaled $100 million.