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Study Presented at ASCO GI 2018 Shows Circulating Tumor Cell Blood Test Detects Early Stage Colorectal Cancer And Pre-Cancer With High Accuracy

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New test could potentially be offered at less than $150 enabling high compliance and global adoption

SUNNYVALE, Calif., Jan. 17, 2018 /PRNewswire/ — CellMax Life, a leading cancer diagnostics company enabling early cancer detection and management with globally affordable non-invasive blood tests, today announced results from a new study showing that its circulating tumor cell (CTC) blood test, based on its proprietary CMxTM platform, can detect colorectal cancer at an early stage – and in many cases, pre-cancerous lesions – with accuracy ranging from 84 to 88 percent.
Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second leading cancer killer in the United States. Traditional methods like colonoscopies and stool-based tests are invasive or inconvenient. For these reasons, compliance with colorectal cancer screening remains low, leading to most colorectal cancers being detected in late stages, when survival rates are poor.

“The positive results of this study prove that the CellMax CTC blood test can address the unmet need for a convenient and accurate test for early colorectal cancer detection; since the test only requires a routine blood draw, it can be easily integrated into a patient’s regular physical exam, increasing compliance,” said study co-author Ashish Nimgaonkar, MD, a gastroenterologist and medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University. “Additionally, research conducted by the American Cancer Society and Centers for Disease Control and Prevention states that test affordability is the number one reason patients cite for not undergoing regular screening for colorectal cancer. This blood test could potentially be offered between $100 and $150.”

CTCs are cancer cells that detach from a primary tumor and circulate through the bloodstream and are a fundamental mechanism of metastasis. CTCs have long been known to be valuable in cancer detection, but most technologies using CTCs are only able to detect late-stage cancer. The CellMax CTC blood test “liquid biopsy” detects these CTCs in the blood at the earliest stages. This is one of the first clinical studies to show that CTCs can be useful for detecting early, more treatable stages of cancer.

The researchers enrolled 620 people over the age of 20 who were either visiting the hospital for routine colonoscopies or had confirmed colorectal cancer. After a colonoscopy and biopsy, 438 people were found to have either adenomatous polyps (pre-cancerous growths) or early to late-stage colorectal cancer. The remaining study participants had no signs of pre-cancerous growths or colorectal cancer and were the comparison group.

Two milliliters (about half a teaspoon) of peripheral whole blood were tested from each subject for CTC analysis through a routine blood draw. The blood samples were then processed through the CMx platform. The results of these assays were then compared in a blinded analysis with the colonoscopy results.

The study results showed that the test’s sensitivity ranged from 77 percent for detection of CTCs in pre-cancerous lesions to 87 percent for stage I-IV cancers. The accuracy of the results, taking into account both sensitivity and specificity, was high and ranged from 84 to 88 percent for pre-cancerous and cancerous samples. Additionally, the accuracy of this test was superior to that of fecal occult blood testing (FOBT), a guideline-recommended stool test for colorectal cancer screening.

“Early detection is perhaps the only real cure for cancer. To be effective, tests for early cancer detection need to be non-invasive, easy, highly affordable and accurate, and our CTC blood test meets all of these requirements,” said Atul Sharan, co-founder and CEO of CellMax Life. “Recent surveys reveal a preference for blood tests over stool-based screening tests in more than 80 percent of patients who did not undergo invasive colonoscopy screening. This test can be an option for these individuals and boost compliance.”

The authors are planning more studies in Taiwan and will be extending the studies to the United States. The fundamental mechanism of circulating tumor cell shedding, and the capture using the CMx platform, are the same across all solid tumors. Thus, this platform is expected to provide favorable results for other solid tumors such as breast, lung and prostate cancers.

The data from the study, sponsored by Taiwan’s Ministry of Health and its largest hospital, the Chang Gung Memorial Hospital, will be presented by lead author, Dr. Wen-Sy Tsai (MD, Ph.D.) at the 2018 ASCO Gastrointestinal Cancers Symposium on Saturday, January 20. Attendees can also visit CellMax Life at booth #27 at the conference to learn more about the CellMax CTC blood test for colorectal cancer and the study’s results.

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.

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Antenna Group
Nathan Molinari (Media Contact)