Study Presented at ASCO GU 2018 Shows Circulating Tumor Cell Blood Test May Enhance Utility of PSA Screening By Reducing Unnecessary Prostate Biopsies By Up To 90%

SUNNYVALE, Calif. and TAIPEI, Taiwan, Feb. 6, 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 200-patient study showing that its circulating tumor cell (CTC) blood test, based on its proprietary CMx^TM platform, can detect early-stage prostate cancer in patients with indeterminate levels of prostate-specific antigen (PSA), with a sensitivity of 80 percent and a specificity of more than 90 percent. These results illustrate the test's potential to reduce unnecessary prostate biopsies by up to 90 percent.

This follows the American Society of Clinical Oncology's (ASCO) recent highlighting of a 620-patient study that showed that the CellMax CTC blood test for colorectal cancer detected early stage cancer ? and in many cases, pre-cancerous lesions ? with accuracy ranging from 84 to 88 percent.

Recent evidence published in the Annals of Internal Medicine suggests that PSA screening has led to a decrease in prostate cancer mortality rates. However, many men screened for prostate cancer will receive indeterminate, or "gray zone" results (PSA levels between 4.1 to 10 ng/ml). Three out of four of these men will have a negative biopsy. Undergoing an unnecessary biopsy may lead to side effects in up to 33 percent of patients, including pain, fever, bleeding, infection and transient urinary difficulties. One percent of these patients may even require hospitalization.

Tests that are currently in guidelines to make a biopsy decision based on elevated PSA, are also derived from PSA. These tests have specificities of 40 to 65 percent at 80 percent sensitivity. As a consequence, an unacceptably large number of men will still undergo unnecessary biopsies.

"Our results suggest that this novel blood test, based on circulating tumor cells, may offer a solution for this clinical unmet need," said lead study author Dr. Jacob See-Tong Pang, independent PI and professor of uro-oncology at Chang Kung Memorial (Linkou) Hospital, the largest hospital in Taiwan. "These results are also significant because they are among the first to show that CTCs can be used for early detection of prostate cancer. Based on this promising result, we are expanding this study to 250 additional patients." The authors will also be extending the studies to the United States.

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 "liquid biopsy" test detects these CTCs in the blood at the earliest stages of prostate cancer.

The investigators enrolled 200 people over the age of 20 who had undergone routine screening, including a PSA test and a digital rectal exam (DRE). Patients with PSA levels in the gray zone and those diagnosed as 'diseased' based on their PSA and DRE also underwent a biopsy. Two milliliters (about half a teaspoon) of peripheral whole blood was tested using the CellMax CTC blood test. This proprietary test uses a microfluidic biochip to capture and enumerate CTCs with antibodies to EpCAM, CK18 and PSMA. Multivariate models incorporating the test results were then utilized to derive age-adjusted CTC scores predictive of clinical outcomes.

84 subjects with PSA levels in the gray zone were included in this study with biopsy results available for 42 patients. A CTC score was calculated as a nonlinear weighted combination of the CTCs identified by CK18 and PSMA antibodies. After adjusting for age and PSA, the CTC score remained a significant predictor of clinical outcomes in the PSA gray zone.

"PSA testing is important for the early detection of cancer, especially for high risk populations such as African Americans. These results show that the CellMax CTC test could enhance the utility of PSA testing," said study co-author Dr. Mahul Amin, chair of the department of pathology at the College of Medicine at the University of Tennessee's Health Science Center. "Current tests for this population are expensive and cost anywhere between $400 and $1000 and are not always covered by insurance or Medicare." CellMax's goal is to ultimately offer this test at a $150 price point.

The fundamental mechanism of circulating tumor cell shedding, and their capture using the CMx platform, is the same across all solid tumors. Thus, this platform is expected to provide favorable results for other solid tumors such as breast and lung. The test is currently commercially available in Asia.

The data from the study, will be presented by lead author Dr. See-Tong Pang at the 2018 ASCO Genitourinary Cancers Symposium on Thursday, February 8. Attendees can also visit CellMax Life at booth #37 during the conference to learn more about the CellMax CTC blood test for prostate 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, including 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 Detection 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
Nathan Molinari (Media Contact)
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SOURCE CellMax Life