SUNNYVALE, Calif., and ROSWELL, Ga.—CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, recently announced the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing.
The financing will be used to accelerate the clinical development of CellMax’s multimodal liquid biopsy test, FirstSight, for the detection of colorectal cancer and pre-cancerous polyps, also known as advanced adenomas. CellMax recently initiated a multicenter U.S. study to further optimize its proprietary algorithm and cell capture techniques. CellMax and Sebela will collaborate on completing the development of FirstSight and, following approval from the U.S. Food and Drug Administration, Sebela will commercialize the test in the United States.
“For the last several years, we have closely followed the industry’s development of colorectal cancer liquid biopsies,” said Alan Cooke, chief executive officer, Sebela Pharmaceuticals. “Sebela and our subsidiary, Braintree, have worked with gastroenterologists for over 35 years, and we expect FirstSight to play a central role in the future of colorectal cancer screening. FirstSight may not only enable the U.S. to exceed its 80 percent screening rate target, as set by the National Colorectal Cancer Roundtable, but can also help detect pre-cancerous adenomas early, referring patients to colonoscopy for preemptive removal.”
This partnership complements Sebela’s portfolio of gastroenterology and colonoscopy preparation products, which are utilized to facilitate colonoscopies, the “gold standard” for the prevention and detection of colorectal cancer. Colonoscopies remain the only means of removing detected pre-cancerous lesions to prevent colorectal cancer.
At the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium, Dr. Shai Friedland, professor of medicine at Stanford University Medical Center and chief of gastroenterology at the VA Palo Alto Health Care System, presented results from a prospective study performed on 458 subjects utilizing FirstSight, a multimodal assay comprised of circulating dysplastic epithelial cells and circulating tumor DNA mutation markers, in combination with a proprietary algorithm.
“A test that detects only colorectal cancer, and not adenomas, will result in missed opportunities to prevent cancer and subject patients to invasive cancer treatments,” said Dr. Friedland. “Today, there is not a single non-invasive screening test that can accurately detect pre-cancerous polyps even nearly as effective as a colonoscopy. Our study data with the FirstSight blood test continues to show consistent ability to detect advanced adenomas with high sensitivity, enabling removal before they progress to carcinomas.”