The study will evaluate the Company’s novel mitochondrial DNA-based test for accurately identifying prostate cancer in blood samples from men with elevated PSA levels that are at risk for prostate cancer.
Jupiter, FL, December 16, 2014 – MDNA Life Sciences Inc. (MDNA), a molecular diagnostics company pioneering the development of diagnostic tests based on the mitochondrial genome, announced today that it has entered into an agreement with the University of Cambridge to conduct a two-part validation study for MDNA’s non-invasive blood-based test for prostate cancer. The study will evaluate the Company’s novel mitochondrial DNA-based test for accurately identifying prostate cancer in blood samples from men with elevated PSA levels that are at risk for prostate cancer. Preliminary results from the first phase of the study are expected in the second half of 2015, with full results expected in early 2016. Together the study findings are expected to support U.S. product launch and commercialization in 2016.
MDNA’s diagnostic tests are developed on the foundation of more than a decade of research exploring the unique role of mitochondrial DNA in disease pathways. This novel platform has led to the discovery of more than 16,000 unique and proprietary biomarkers for a multitude of cancers and other diseases. Due to the unique biological properties of mitochondrial DNA, MDNA’s proprietary tests are able to identify early stages of disease progression, including changes that occur before typical disease symptoms manifest.
Jennifer Creed, Chief Development Officer of MDNA Life Sciences, commented, “MDNA has been fortunate to engage with the University of Cambridge for this clinical study and access its very well-characterized patient samples for the development of this test. Only 30% of men with elevated PSA who undergo a painful and expensive biopsy are diagnosed with prostate cancer, so clearly better screening prior to biopsy is greatly needed. We believe our blood-based diagnostic will provide an accurate, non-invasive, and cost-effective method for screening high-risk patients for prostate cancer.”
The collaboration with the University of Cambridge will be led by the University’s Oncology Research Group Leader, Professor Vincent Gnanapragasam, BMedSci, MBBS, MA, PhD, FRCS, FRCSEd(Urol). Dr. Gnanapragasam is an academic consultant urological surgeon at the University of Cambridge and Addenbrookes Hospital, Cambridge. He was the first urologist and surgeon to be awarded a Cancer Research UK Clinician Scientist Fellowship and is a recipient of a Hunterian Professorship from the Royal College of Surgeons of England. His primary research interests include the use of biomarkers for personalized risk stratification for urologic cancers, which ultimately attracted him to this collaboration with MDNA Life Sciences.
About MDNA Life Sciences
MDNA Life Sciences, Inc. is pioneering the development of molecular diagnostic tests based on the mitochondrial genome. The company’s revenue-generating Prostate Core Mitomic Test™ (PCMT™) is the highest performing tissue-based prostate cancer diagnostic on the market with a significantly greater tumor field effect that allows 85% sensitivity and 92% negative predictive value. MDNA is applying its expertise in mitochondrial genomics to developing an extensive and proprietary portfolio of blood-based molecular tests in conditions that are currently dependent on poor or absent screening tests or invasive procedures for detection. Blood-based diagnostic tests for prostate cancer and endometriosis are in late stage development. For more information visit mdnalifesciences.com.