A clinical study published in the American Health & Drug Benefits journal describes the Mitomic Prostate Core Test’s impact on patient management and the biopsy decision-making process.
WEST PALM BEACH, Fla., Jan. 11, 2017 /PRNewswire/ – MDNA Life Sciences Inc. (MDNA), a molecular diagnostics company specializing in the development of diagnostic tests based on the mitochondrial genome, announced today that findings of a key in-market clinical study have been published in the peer-reviewed journal American Health & Drug Benefits describing the impact of the use of its Prostate Core Mitomic Test (PCMT™) on patient management and the biopsy decision-making process.
In this study of 1467 men, the authors sought to evaluate whether an impact on repeat biopsy rates was observed following either a positive or negative PCMT test result through comparison to men who did not have PCMT as a part of their care. Findings support the continued use of PCMT for better selection of men for repeat biopsy as repeat biopsy rates decreased 8- fold for men with a negative PCMT test result. Additionally, men with positive PCMT results proceeded to repeat biopsy an average of 2.5 months earlier than men without PCMT, with cancer identified on biopsy at slightly higher rates than the men without the benefit of PCMT to inform their decision-making process. Finally, in the subset of men with a PCMT test result and a follow-up biopsy, the authors were able to confirm the in-market performance of PCMT was within the 95% confidence intervals of the prior published case-control study for the key metrics of sensitivity and negative predictive value, originally reported as 85% and 92%. “This real-world evidence collated by partners in the medical community is critically important to providing confidence that tests such as PCMT™, once in the market, are having the desired impact on patient management and help demonstrate that we are successfully driving the industry closer to our collective goals of better allocation of health care resources and more personalized care,” says Chris Mitton, CEO of MDNA Life Sciences.
As a result of this strong evidence for improved and more cost-effective patient care, MDNA intends to leverage the study to support reimbursement for testing for the more than 23 million men covered by Medicare in the US, as well as improve coverage among private payors. “This study represents a significant milestone not only for PCMT but also for validation of the capabilities of our Mitomic Technology platform to develop tests that are clinically beneficial for prostate cancer as well as other diseases with a great unmet clinical need,” adds Mitton.
MDNA has recently announced the launch of its new blood-based test for prostate cancer, the Prostate Mitomic Test™, which detects the same mitochondrial DNA mutation as PCMT but does not require prostate biopsy tissue, increasing access to men with clinical suspicion of prostate cancer who have yet to endure an invasive biopsy procedure.
About the Prostate Core Mitomic Test™
PCMT™ tests prostate biopsy tissue obtained for conventional pathology review to determine whether elevated quantities of a particular large-scale mitochondrial DNA deletion mutation are detectable. This mutation is known to be elevated in prostate cancer cells as well as normal-appearing prostate cells co-existing with cancer. PCMT™ has a very high sensitivity producing a low false-negative rate, missing fewer cancers than other comparable biomarker tests. As many men are erroneously indicated for biopsy due to elevated PSA the adjunct use of PCMT™ provides the opportunity to significantly reduce the number of men needing biopsy due to suspicion of prostate cancer.
About MDNA Life Sciences Inc.
MDNA Life Sciences, Inc. is leading the development of molecular diagnostic tests using its proprietary Mitomic Technology™ platform that exploits the unique biological characteristics of mitochondrial DNA. This innovative platform is a highly attractive and effective system for biomarker discovery, early disease detection, monitoring, risk assessment and therapeutic targeting. It has led to the discovery of numerous novel and proprietary biomarkers for a multitude of cancers and other diseases. The Company is applying its expertise in mitochondrial genomics to develop an extensive and proprietary portfolio of blood-based molecular tests for conditions that are currently dependent on poor or absent screening tests or invasive procedures for detection.
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