CellMax Life Launches Zenith, a U.S. Clinical Study for the Advancement of Blood Tests for Early Cancer Detection, With the Goal of Seeking FDA Approval
Study expected to improve upon ASCO GI results that showed 84 to 88 percent accuracy at a sub-$200 price point for the test
SUNNYVALE, Calif., May 30, 2018 /PRNewswire/ -- CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, today announced it is commencing Zenith, a U.S. clinical study for its circulating tumor cell (CTC) blood test, which can transform the way colorectal cancer is detected, enabling diagnosis at its earliest, most treatable stages.
To do this, the company is first initiating a study with leading U.S. medical centers including Stanford Medicine and the U.S. Department of Veterans Affairs Palo Alto Health Care System, Johns Hopkins and University of Southern California. This U.S. trial comes on the heels of an Asian trial, for which results were announced at the 2018 ASCO Gastrointestinal Cancer Symposium (ASCO GI) in January, which demonstrated that the test can detect colorectal cancer at an early stage with accuracy ranging from 84 to 88 percent.
In this study, thousands of patients coming in for routine colorectal cancer screening via colonoscopy or stool tests will be offered CellMax Life's blood test. The results of the blood test will be compared to those from the colonoscopy and stool tests.
"We plan to work closely with the FDA upfront to define the details of this study," said Atul Sharan, CEO of CellMax Life. "We will also pursue reimbursement for the test by submitting it through the Parallel Review Program for approval from the FDA and coverage determination by Centers for Medicare and Medicaid Services (CMS). The test requires just a single tube of blood and is at a price point of less than $200, which makes this a very practical solution for colorectal cancer screening."
"Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second deadliest cancer in the United States partly because of lack of compliance. One in three eligible Americans have never been screened because current testing options like colonoscopies and stool-based tests are invasive or inconvenient, deterring people from getting screened," said Shai Friedland, M.D., Chief of Gastroenterology & Hepatology, VA Palo Alto Health Care System from the Stanford University School of Medicine, as well as lead principal investigator (PI) on this study. "After CellMax Life's blood test showed such impressive results at ASCO GI, we believe it can address the unmet need for a convenient, accurate and affordable test for early colorectal cancer detection. I expect physicians will adopt it as a first-line screening option for all patients, with colonoscopy as the confirmatory diagnostic for patients who are positive per the CellMax test."
While testing for CTCs has been approved and validated by the FDA as a useful detection method for late stage metastatic cancer, there has not yet been a CTC technology with the sensitivity required for early cancer detection. CellMax Life's CMx™ ultra-sensitive CTC platform, which isolates rare CTCs present at a fraction of 1 to 10 CTCs in a background of one billion normal cells in pre-cancer and early stage cancer breaks this barrier. This platform has eight patents and is the only clinically proven CTC platform able to detect cancer early.
"The ASCO GI results showed that the blood test can detect pre-cancerous lesions at a higher sensitivity than stool tests. This is significant because these lesions can be safely and easily removed with a follow-on colonoscopy. Also, unlike home stool tests, which in our experience are only completed by around 30 percent of patients that order the kit, this test can be easily integrated into a patient's annual physical exam, increasing compliance," said Ashish Nimgaonkar, M.D., a gastroenterologist, medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University and one of the PIs on this study.
"An affordable test with keen sensitivity for early cancer detection like the CTC blood test has the potential to transform cancer diagnostics," said Dr. Heinz-Josef Lenz, Medical Oncologist, Professor of Medicine at the Keck School of Medicine, USC. "The potential applications can go well beyond early detection to monitoring treatment efficacy and detect resistance to therapies, as well as for recurrence monitoring for 15 million Americans who have been diagnosed with cancer."
About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. CellMax Life's unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.
CellMax Life's tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.
For additional information, please visit www.cellmaxlife.com.
Antenna Group
Michael Simmons (Media Contact)
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SOURCE CellMax Life
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