SUNNYVALE, Calif., Aug. 25, 2021 (GLOBE NEWSWIRE) -- CellMax Life, a molecular diagnostics company, announced today that its FirstSight™ pre-cancer and cancer detection blood test has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The blood test is based on CellMax Life's proprietary platform technology for detecting cancer and pre-cancer.
According to the FDA, its Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices by speeding up their development, assessment, and review process while preserving statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The designated device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition.
In addition, Breakthrough Designation may provide reimbursement benefit, subject to ongoing CMS consideration of the previously proposed Medicare Coverage of Innovative Technology (MCIT) program.
The FirstSight blood test, also known as a liquid biopsy, is designed to uniquely measure colorectal neoplasia associated epithelial cells and DNA markers in human blood. These results, combined with age and gender, are integrated into a proprietary multi-modal algorithm to generate a qualitative binary result of either low or high-risk for advanced neoplasia.
CellMax’s latest publicly available study results were presented in May 2021. The study was conducted with the Stanford Veterans Administration Palo Alto Healthcare on 458 screening and low risk surveillance subjects1. FirstSight demonstrated a sensitivity for CRC (TNM stage I-IV) at 100% (14/14, 95% Confidence Interval 78.5%-100%) and a sensitivity for advanced adenomas at 74.2% (49/66, CI 62.3%-83.3%). The specificity (negative colonoscopy or non-neoplastic findings) was 90.8% (139/153, CI 85.2%-94.5%).
Since then, CellMax Life announced a Series C financing in early 2021, led by Sebela Pharmaceuticals, and has since initiated a multicenter U.S. study to further optimize its proprietary algorithm, prior to initiating its pivotal study. The above numbers do not reflect this unpublished data.
“Colorectal cancer is the number two cancer killer in the US among cancers that affect both men and women, with $14B spent annually on the treatment of a preventable cancer," said Atul Sharan, CellMax Life President & CEO.
Sharan continued: "What is needed is a non-invasive blood-test that can increase compliance -- and more importantly can screen for precancerous polyps, so they can be removed before they turn into cancer. This breakthrough designation from the FDA validates and furthers our progress toward this goal.”
About CellMax Life
CellMax Life is a diagnostics company focused on cancer screening with proprietary technology for detecting precancerous and cancer cells and genomic aberrations in a single blood sample. CellMax Life is headquartered in Sunnyvale, California and has a CLIA certified and CAP accredited laboratory at this location. For more information, visit http://www.cellmaxlife.com.
The FirstSight test is an investigational device that is not available for sale in the United States.
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