Data shows 92% sensitivity for colorectal cancer and 55% sensitivity for precancerous advanced adenomas at 91% specificity. Data to be presented at ASCO Gastrointestinal Cancers Symposium
SUNNYVALE, Calif., Jan. 18, 2023 /PRNewswire-PRWeb/ -- CellMax Life, a molecular diagnostics company with a proprietary colorectal cancer screening blood test, today announced positive results from a multisite U.S. study that showed that its FirstSightTM blood test is highly accurate in detecting colorectal cancer, as well as advanced adenomas.
The data from this prospective study showed that CellMax's FirstSight blood test demonstrated 92% sensitivity for colorectal cancer and 55% sensitivity for advanced adenomas at 91% specificity. This data aligns well with the 16-year follow-up of the National Polyp Study, in which investigators made the case that advanced adenomas should be a primary target of colorectal cancer screening.
"Simply put, colorectal cancer is preventable; many cases that occur could have been avoided had the right screening tests been performed in a timely manner," said Douglas K. Rex, MD, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Former President of the American Society for Gastrointestinal Endoscopy and Former Chair of the U.S. Multi-Society (ACG, ASGE, AGA) Task Force on Colorectal Cancer. "In order to significantly reduce the incidence of colorectal cancer, an effective and easy screening test is critical. This is why I am very enthusiastic about this data on CellMax's FirstSight. The study demonstrated numerically better detection of advanced adenomas than the best performing commercially available fecal tests, as well as other blood tests that are currently under development and have publicly disclosed their performance."
The study was designed to reflect an asymptomatic average-risk U.S. screening population and consisted of 1038 samples collected from patients between the ages of 45-80 across 18 geographically dispersed sites. Of these 1038 samples, 954 were asymptomatic, average-risk screening patients without age enrichment, including 11 patients with colorectal cancer (2 stage I, 3 stage II, 6 stage III) and 93 patients with advanced adenomas. Additionally, 84 were case-control diseased patients with 65 known cases of colorectal cancer (9 stage I, 20 stage II, 22 stage III, 6 stage IV, 8 unstaged), and 19 known cases of advanced adenomas prior to resection to increase statistical power. All negative samples were collected from the average- risk screening cohort, and there were no negative case-control samples.
These results demonstrate best-in-class performance for detection of advanced neoplasia (colorectal cancer and advanced adenomas). CellMax's FirstSight is the first blood test that is superior to stool tests in detecting advanced adenomas and colorectal cancer.
"There is a significant clinical unmet need when it comes to detecting colorectal cancer and pre-cancer," said Shai Friedland, MD, lead principal investigator on the study and gastroenterologist at Stanford Medicine. "The results from this study are incredibly promising, showing significant potential for this test for colorectal non-invasive cancer screening, thereby increasing our ability to prevent more cancers."
The multi-modal FirstSight blood test differs significantly from other first-generation ctDNA blood tests. It is able to detect advanced adenomas by combining signatures, not just from ctDNA but also from methylation along with rare epithelial cells shed from adenomas using the company's proprietary circulating epithelial cells technology. These are all combined into a proprietary algorithm that also captures interaction between these selective biomarkers.
"There are too many unnecessary deaths from colorectal cancer," said Atul Sharan, co-founder and CEO of CellMax Life. "Our mission with FirstSight is to find precancerous adenomas that have a high likelihood of progression to cancer and detect them before they develop into cancer. To that end, the study was designed and analyzed such that there can be high confidence that the results will be reproduced in a larger premarket approval study."
Based on clinical data showing FirstSight's ability to detect both colorectal cancer and advanced adenomas with high sensitivity, CellMax received Breakthrough Device Designation from the U.S. Food and Drug Administration in Q3 2021.
This data will be presented at ASCO Gastrointestinal Cancers Symposium, taking place on January 19-21, 2023. Details for the poster presentation include:
Poster Session C: Cancers of the Colon, Rectum, and Anus January 21, 2023, at 6:30 AM PST Location: Level 1, West Hall Poster Abstract #75, Poster Board D12 Presented by Lead PI Dr. Shai Friedland of Stanford University Medical Center Gastroenterology and Hepatology
CellMax plans to begin a premarket approval study, with an intermediate endpoint for advanced adenoma due to their higher prevalence relative to cancer and an end-of-study endpoint of advanced adenoma plus colorectal cancer (advanced neoplasia) test that provides increased level of evidence to cancer detection due to lower prevalence. If approved, FirstSight blood test will help increase routine screening compliance for patients who are reluctant to undergo a colonoscopy or stool testing and may help prevent colorectal cancer by detecting the disease at the advanced adenoma stage.
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 an accredited laboratory at this location. For more information, visit http://www.cellmaxlife.com.
Media Contact: Leonard Fontes III [email protected] (201) 874-6317
Media Contact
Leonard Fontes III, CellMax Life, 1 (201) 874-6317, [email protected]
SOURCE CellMax Life
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SUNNYVALE, Calif., Jan. 18, 2023 /PRNewswire-PRWeb/ -- CellMax Life, a molecular diagnostics company with a proprietary colorectal cancer screening blood test, today announced positive results from a multisite U.S. study that showed that its FirstSightTM blood test is highly accurate in detecting colorectal cancer, as well as advanced adenomas.
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The data from this prospective study showed that CellMax's FirstSight blood test demonstrated 92% sensitivity for colorectal cancer and 55% sensitivity for advanced adenomas at 91% specificity. This data aligns well with the 16-year follow-up of the National Polyp Study, in which investigators made the case that advanced adenomas should be a primary target of colorectal cancer screening.
"Simply put, colorectal cancer is preventable; many cases that occur could have been avoided had the right screening tests been performed in a timely manner," said Douglas K. Rex, MD, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Former President of the American Society for Gastrointestinal Endoscopy and Former Chair of the U.S. Multi-Society (ACG, ASGE, AGA) Task Force on Colorectal Cancer. "In order to significantly reduce the incidence of colorectal cancer, an effective and easy screening test is critical. This is why I am very enthusiastic about this data on CellMax's FirstSight. The study demonstrated numerically better detection of advanced adenomas than the best performing commercially available fecal tests, as well as other blood tests that are currently under development and have publicly disclosed their performance."
The study was designed to reflect an asymptomatic average-risk U.S. screening population and consisted of 1038 samples collected from patients between the ages of 45-80 across 18 geographically dispersed sites. Of these 1038 samples, 954 were asymptomatic, average-risk screening patients without age enrichment, including 11 patients with colorectal cancer (2 stage I, 3 stage II, 6 stage III) and 93 patients with advanced adenomas. Additionally, 84 were case-control diseased patients with 65 known cases of colorectal cancer (9 stage I, 20 stage II, 22 stage III, 6 stage IV, 8 unstaged), and 19 known cases of advanced adenomas prior to resection to increase statistical power. All negative samples were collected from the average- risk screening cohort, and there were no negative case-control samples.
These results demonstrate best-in-class performance for detection of advanced neoplasia (colorectal cancer and advanced adenomas). CellMax's FirstSight is the first blood test that is superior to stool tests in detecting advanced adenomas and colorectal cancer.
"There is a significant clinical unmet need when it comes to detecting colorectal cancer and pre-cancer," said Shai Friedland, MD, lead principal investigator on the study and gastroenterologist at Stanford Medicine. "The results from this study are incredibly promising, showing significant potential for this test for colorectal non-invasive cancer screening, thereby increasing our ability to prevent more cancers."
The multi-modal FirstSight blood test differs significantly from other first-generation ctDNA blood tests. It is able to detect advanced adenomas by combining signatures, not just from ctDNA but also from methylation along with rare epithelial cells shed from adenomas using the company's proprietary circulating epithelial cells technology. These are all combined into a proprietary algorithm that also captures interaction between these selective biomarkers.
"There are too many unnecessary deaths from colorectal cancer," said Atul Sharan, co-founder and CEO of CellMax Life. "Our mission with FirstSight is to find precancerous adenomas that have a high likelihood of progression to cancer and detect them before they develop into cancer. To that end, the study was designed and analyzed such that there can be high confidence that the results will be reproduced in a larger premarket approval study."
Based on clinical data showing FirstSight's ability to detect both colorectal cancer and advanced adenomas with high sensitivity, CellMax received Breakthrough Device Designation from the U.S. Food and Drug Administration in Q3 2021.
This data will be presented at ASCO Gastrointestinal Cancers Symposium, taking place on January 19-21, 2023. Details for the poster presentation include:
Poster Session C: Cancers of the Colon, Rectum, and Anus January 21, 2023, at 6:30 AM PST Location: Level 1, West Hall Poster Abstract #75, Poster Board D12 Presented by Lead PI Dr. Shai Friedland of Stanford University Medical Center Gastroenterology and Hepatology
CellMax plans to begin a premarket approval study, with an intermediate endpoint for advanced adenoma due to their higher prevalence relative to cancer and an end-of-study endpoint of advanced adenoma plus colorectal cancer (advanced neoplasia) test that provides increased level of evidence to cancer detection due to lower prevalence. If approved, FirstSight blood test will help increase routine screening compliance for patients who are reluctant to undergo a colonoscopy or stool testing and may help prevent colorectal cancer by detecting the disease at the advanced adenoma stage.
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 an accredited laboratory at this location. For more information, visit http://www.cellmaxlife.com.
Media Contact: Leonard Fontes III [email protected] (201) 874-6317
Media Contact
Leonard Fontes III, CellMax Life, 1 (201) 874-6317, [email protected]
SOURCE CellMax Life
