Cell-Free DNA Accurately Correlates with Breast Cancer DNA

CHICAGO--(BUSINESS WIRE)--

Researchers from Chronix Biomedical and The University of Texas MD Anderson Cancer Center today announced that results from a pilot study demonstrating the utility of cell-free DNA (cfDNA) blood tests as a companion diagnostic for breast cancer patients are to be reported in a poster presentation titled Modulation of breast cancer cell-free DNA with surgical resection (Abstract #11060) at the American Society of Clinical Oncology Annual Meeting (ASCO 2013) being held from May 31 through June 4, 2013 in Chicago. The blood test detects cfDNA that is released into the blood stream by damaged and dying cancer cells.

In the study, researchers applied advanced next-generation sequencing (NGS) techniques to identify tumor-associated cfDNA in 16 breast cancer patients undergoing surgical excision of their primary breast cancer. Analysis of pre- and post-surgery serum demonstrated that cfDNA cancer biomarkers were present in the pre-surgery serum and in the original tumor biopsy, and were not observed in white blood cell (WBC) genomic DNA. In 13 of 16 patients (81%) analyzed, the post-surgery cfDNA was free of detectable tumor-related DNA. In the remaining 3 patients only a partial reduction in tumor-specific DNA serum biomarkers was detected, since some markers were still detectable after surgery. This preliminary finding is the basis for a larger planned study designed to determine if residual tumor cfDNA after surgery is a marker of minimal residual disease, which can be pursued as a prognostic marker.

In addition, the researchers expect to expand this study to a larger cohort of women undergoing neoadjuvant therapy (NAT) involving several rounds of chemotherapy, typically followed by surgery to remove the tumor in an effort to increase the probability of achieving complete elimination of cancer cells. A major problem is that a high percentage of patients undergoing NAT have a complete pathological response to the chemotherapy with eradication of all tumor in the breast and lymph nodes. However, as there is currently no accurate way to identify patients who had a complete response surgery is routinely performed on all patients after NAT. A biomarker companion diagnostic blood test for the real-time monitoring of cancer would enable the physician to determine whether cancer actually remains in the body post-therapy.

If we are successful in further validating this innovative research, a major advance will be made toward providing a new era of personalized medicine, said Professor Funda Meric-Bernstam, M.D., Chair, Department of Investigational Cancer Therapeutics, and Medical Director, Institute of Personalized Cancer Therapy, MD Anderson, and Principal Investigator of the study.

This study is exciting and has the potential to greatly improve the outcome for breast cancer patients. We expect to be able to transition the approach to many other tumor lineages. Thus the proposed study should have a major impact on cancer patient management and outcomes, said Professor Gordon Mills, M.D., Chair of Systems Biology at MD Anderson.

These positive data provide the basis for the continued development of minimal residual disease blood tests for as many cancer types as possible. These tests have the potential to track responses to any oncology treatment, and are expected to significantly enhance patient care while greatly reducing the cost to the healthcare system, said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix Biomedical.

About Chronix Biomedical

Chronix Biomedical is a molecular diagnostics company developing blood tests primarily for cancer, including companion diagnostics and tests for detecting minimal residual disease. Chronix is preparing to offer its pioneering tests through its own laboratories under CLIA certification in North America and the CE mark in Europe. The Companys initial product is a test to be used by cancer treatment centers and oncologists in the treatment of breast cancer patients.

Chronix is privately held with headquarters in San Jose, California, and laboratories in Gttingen, Germany and Brookings, South Dakota. It was the first Company to use next-generation sequencing on cell-free DNA. The Company has two issued patents on the detection of cell-free DNA and RNA, and four patents pending using next-generation sequencing technology for the detection of breast cancer, prostate cancer and colorectal cancer all of which can be done without the need for a tumor sample. For additional information please visit http://www.chronixbiomedical.com.

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Cell-Free DNA Accurately Correlates with Breast Cancer DNA