Performance measurements from the first phase of our ongoing two-part validation study for the Prostate Core Mitomic Test™ for prostate cancer yield positive results.
Jupiter, FL, September 1, 2015 – MDNA Life Sciences Inc. (MDNA), a molecular diagnostics company pioneering the development of diagnostic tests based on the mitochondrial genome, announced today positive preliminary results from the first phase of its ongoing two-part validation study for the Company’s blood-based test for prostate cancer, which is being carried out in collaboration with the University of Cambridge. Performance measurements from the first phase were consistent with the encouraging outcomes of MDNA’s earlier clinical studies and with its top-performing tissue-based test, the Prostate Core Mitomic Test™ (PCMT), which is currently commercialized in the U.S.
Jennifer Creed, Chief Development Officer of MDNA Life Sciences, commented, “We’re very encouraged by these initial results, which appear to confirm our proprietary mitochondrial DNA-based biomarker as a powerful, independent predictor of prostate cancer. Our potentially market-disruptive test was able to achieving a level of accuracy that can justify its use as a valuable selective screening tool for diagnosing men in the early stages of disease.”
Full results from the two-part validation study are anticipated for early 2016, and are expected to support U.S. commercialization of the test in the first half of 2016, and in the UK later in the year.
George Steinfels, Ph.D., Interim Chief Executive Officer of MDNA Life Sciences, commented, “We are extremely proud of the achievements of our scientific team and our collaborators in bringing such an important test successfully through these validation endpoints. Delivering better diagnostics based on superior biomarkers is at the core of our commercial strategy, which is focused on empowering clinical insights, improving disease management and reducing healthcare costs, while increasing patient access to next-generation medicines at times when they would be most effective against their disease.”
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.