SUNNYVALE, Calif., and ROSWELL, Ga.—CellMax Life, a molecular diagnostic firm with proprietary technology for the detection of pre-cancer and cancer blood tests, and Sebela Pharmaceuticals, a gastroenterology market leader, recently completed a strategic development and commercial partnership agreement, as well as CellMax’s Series C financing.
The funding will go towards the acceleration of the clinical development of CellMax’s multimodal liquid biopsy test, FirstSight, to detect colorectal cancer and pre-cancerous polyps, or advanced adenomas. CellMax just launched a multicenter U.S. trial to further refine its exclusive algorithm and cell capture methods.
CellMax and Sebela will jointly work to finalize the development of FirstSight and, after U.S. approval,. Food and Drug Administration, Sebela will make the test commercially available in the United States.”For the past few years, we have been watching closely as the industry has been developing liquid biopsies for colorectal cancer,” said Alan Cooke, chief executive officer, Sebela Pharmaceuticals.
“Sebela and our subsidiary, Braintree, have served gastroenterologists for more than 35 years, and we believe FirstSight will be a key player in the future of colorectal cancer screening.”. FirstSight has the potential to not only help the U.S. reach beyond its target 80 percent screening rate goal, as defined by the National Colorectal Cancer Roundtable, but to identify pre-cancerous adenomas early on, referring them to colonoscopy for preventive removal.
“This deal fits nicely with Sebela’s portfolio of gastroenterology and colonoscopy prep products that are used to make colonoscopies, the “gold standard” in prevention and detection of colorectal cancer, easier.”. Colonoscopies are the sole method of removing pre-cancerous lesions found to prevent colorectal cancer.
At the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium, Stanford University Medical Center professor of medicine and VA Palo Alto Health Care System chief of gastroenterology Dr. Shai Friedland presented findings from a prospective study conducted on 458 participants using FirstSight, a multimodal assay consisting of circulating dysplastic epithelial cells and circulating tumor DNA mutation markers, with a proprietary algorithm.
“A test that finds only colorectal cancer, but not adenomas, will miss the chance to prevent cancer and expose patients to invasive cancer therapy,” said Dr. Friedland. “Currently, there isn’t one non-invasive screening exam that can reliably identify pre-cancerous polyps even as good as a colonoscopy. Our study results with the FirstSight blood test continue to demonstrate consistent capacity to detect advanced adenomas with high sensitivity, allowing removal before they become carcinomas.”