Newswise — HOUSTON and GÖTTINGEN, Germany (JULY 28, 2013) – Researchers from the University Medical Center Göttingen and Chronix Biomedical announce they have received a National Academy of Clinical Biochemistry (NACB) Distinguished Abstract Award for their paper titled “Rapid and Cost Effective Measurement of Circulating Cell Free Graft DNA for the Early Detection of Liver Transplant Rejection.” The paper is based on a pilot study led by Michael Oellerich, M.D., FACB, FRCPath and Lower Saxony Distinguished Professor of Clinical Chemistry at the University Medical Center Göttingen, which demonstrated the utility of cell-free DNA (cfDNA) detected through a blood test as a biomarker to monitor organ transplant rejection.
Study results will be reported in an oral presentation (Abstract #A-93) at the American Association of Clinical Chemistry Annual Meeting (AACC 2013) being held July 28 through August 1, 2013 at the George R. Brown Convention Center in Houston. The test, developed by Chronix Biomedical, detects cfDNA that is released into the blood stream by dying cells from the transplanted organ.
“Despite numerous efforts to develop biomarkers for the early detection of graft rejection, to date none has proven to be effective in minimizing chronic rejections. The direct determination of organ integrity by this new method of detecting subclinical rejection may enable early therapeutic intervention. This is a breakthrough with potential favorable implications for long-term outcomes," said Prof. Oellerich.
In the study researchers applied digital droplet PCR to quantify biomarkers in cfDNA in recent liver transplant patients and in stable patients who had undergone a transplant procedure more than 6 month earlier. In stable patients, an average amount of approximately 5% of the total cfDNA was of donor organ origin, whereas values greater than 15% were seen during the first 5 days following the procedure. One patient with a biopsy-proven rejection at day 43 post-transplantation showed a steep increase in graft cfDNA to greater than 50% on day 32, which was several days before the conventional aspartate aminotransferase (AST) and bilirubin tests detected a significant increase. These findings are the basis for a larger planned study designed to determine if cfDNA is the earliest indication of a transplant organ rejection. Approximately 28,000 organ transplantations are performed each year in the U.S., and there are more than 200,000 organ recipients living in the U.S.
“We are excited to have developed a cost-effective and fast laboratory test with potentially immediate positive impact on patient care,” said Dr. Julia Beck, Senior Scientist and leader of the test development team at Chronix Biomedical, who was also first author of the study.
"This new liquid blood-biopsy approach is another example of the importance of cell-free DNA as a personal biomarker. We believe these types of tests will become the gold standard in laboratory medicine, and will have a near term use to aid therapy after organ transplantation, " said Chronix Biomedical’s Chief Technology Officer and senior author of the study, Ekkehard Schütz, M.D., Ph.D.
“This is another example of the commercial potential of cell-free DNA diagnostics in detecting foreign DNA. We can now extend the applications from fetal DNA in maternal blood and personalized cancer biomarkers to solid organ transplantation,” said Howard Urnovitz, Ph.D., Chronix Biomedical’s Chief Executive Officer
About Chronix Biomedical Chronix Biomedical is a molecular diagnostics company developing blood tests primarily for the detection of foreign DNA in a host. The company is developing organ transplantation blood tests for early rejection as well as blood tests for detecting minimal residual disease in cancer. Chronix is preparing to offer its pioneering tests through its own laboratories under CLIA certification in North America and the CE mark in Europe.
Chronix is privately held with headquarters in San Jose, California, and laboratories in Göttingen, 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 www.chronixbiomedical.com.
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