CellMax Life Announces Positive U.S. Study Results for FirstSight Blood Test to Detect Colorectal Adenomas and Cancer
FirstSight test achieved 90% specificity, with sensitivity of 100% and 76% for detection of colorectal cancer and advanced adenomas, respectively. Data is now available via Digestive Disease Week® (DDW) ePosters and ePapers site.
SUNNYVALE, Calif., May 4, 2020 /PRNewswire-PRWeb/ -- CellMax Life, a diagnostics company with a proprietary technology to detect pre-cancer and cancer cells in the blood, today announced new positive data from its U.S. study (Zenith) evaluating the efficacy of its FirstSight blood test in detecting colorectal adenomas and cancer. While the data was originally planned to be revealed in an oral lecture presentation at the Digestive Disease Week® (DDW) Symposium in Chicago on May 2-5 prior to the conference's cancellation due to the COVID-19 pandemic, it is now available via the DDW ePosters and ePapers site.
The results from this study show that CellMax Life's multimodal blood test, based on its proprietary CMxTM platform, can detect pre-cancers (advanced adenomas) with 75.5% (95% CI: 61.7%-86.2%) sensitivity, at a 90% specificity, while successfully detecting colorectal cancer with 100% (95% CI: 71.5%-100%) sensitivity. The abstract titled "A Highly Sensitive and Quantitative Multimodal Blood Test for the Detection of Colorectal Adenomas and Cancer," was selected from several thousand abstracts for an oral presentation by the principal investigator, Dr. Shai Friedland, Professor of Medicine at Stanford University and Chief of Gastroenterology at the Veterans Affairs Palo Alto Healthcare System. Results are from the prospective clinical study, Zenith, CellMax Life's first U.S. clinical trial, which is being conducted at the Veterans Affairs Palo Alto Health Care System with several leading gastroenterologists. The findings further confirm the proof of concept studies CellMax Life had previously conducted in Asia, which were selected for podium presentation at the 2018 and 2019 ASCO Gastrointestinal Cancers Symposiums.
Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second leading cancer killer in the United States. New guidelines from the American Cancer Society recommend screening for colorectal cancer (CRC) starting at age 45, down from age 50. This means that 20 million Americans from the age of 45 to 50 are newly eligible for testing. Furthermore, a shocking 33 million Americans of the eligible 112 million in the 50-plus age group have never been tested.
Until now, colonoscopies have been the only preventive-screening method with the sensitivity to accurately detect adenomas. Unfortunately, due to their invasive nature, only 38% of Americans seek this method of screening. Noninvasive options exist that are either stool- or blood-based; however, these tests miss a majority of pre-cancers – with a sensitivity as low as 22% – eliminating their preventive role per gastroenterology guidelines. It is for these reasons why most colorectal cancers are not detected earlier, when it's either preventable or when more treatment options are available and survival rates higher.
"For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps," said Dr. Friedland. "These results are very exciting: no other non-invasive test offers this combination of convenience and high sensitivity for detecting precancerous polyps. Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer."
The study enrolled 354 patients with no prior diagnosis of colorectal cancer. Enrolled patients had blood drawn for FirstSight testing, and then immediately after, underwent a colonoscopy. Compared with existing guideline-recommended stool tests, the FirstSight blood test is superior for the detection of advanced and even non-advanced adenomas with high specificity.
"There are over 50,000 colorectal cancer deaths per year in the United States. These are preventable," said Atul Sharan, co-founder and CEO of CellMax Life. "Outcomes in colorectal cancer can only be changed by having a noninvasive test that can effectively detect adenomas and have high compliance."
CellMax Life continues to enroll patients at the Veterans Affairs Hospital and has now opened the study to additional sites across the United States to further validate the FirstSight blood test. While DDW was canceled, individuals can still visit the website to view the published abstract in detail, as well as CellMaxLife.com to learn more about the FirstSight blood test.
About CellMax Life
CellMax Life is a diagnostics company focused on cancer screening with proprietary technology for detecting precancer and cancer cells, and genomic markers 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.
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SOURCE CellMax Life
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