Specimen Testing is Now Commercially Available in the Clinical Laboratories of Helomics Corporation.
PITTSBURGH, PA and WEST PALM BEACH, FL / ACCESSWIRE / May 11, 2017 / Helomics® Corporation (Helomics), a privately-held, healthcare company providing personalized medicine solutions for clients in the pharmaceutical, diagnostic, and biotechnology industries, and MDNA Life Sciences, Inc. (MDNA), the molecular diagnostics company pioneering the development of liquid biopsy tests based on the mitochondrial genome, today announced the commercial launch of MDNA’s liquid biopsy Prostate Mitomic Test™ (PMT™) in selected U.S. markets. This proprietary test, which utilizes MDNA’s Mitomic Technology™ platform, exploits the unique biological characteristics of mitochondrial DNA and is available exclusively in the clinical laboratories of Helomics.
PMT™ is a liquid biopsy test independent of PSA and age for the early detection of high-grade prostate cancer in advance of biopsy. It is intended for use in men with clinical suspicion of prostate cancer to determine who is likely to have high-grade cancer that may require immediate intervention. PMT’s high negative predictive value will also be useful in identifying cases that can safely delay or forego immediate biopsy. Current clinical practice using PSA as a first-line screening tool results in many unnecessary biopsies. PMT™ aids clinicians in differentiating between men who will benefit from immediate biopsy from those who will not, thus avoiding a costly and invasive procedure.
Gerald J. Vardzel Jr., President and CEO of Helomics, said, “We are extremely excited about the launch of the first clinical test commercialized as a result of our strategic collaboration with MDNA. We are very pleased that MDNA has chosen us to be their commercialization partner and we are looking forward to collaborating with them to bring additional diagnostic tests, based on their proprietary mitochondrial DNA platform, to the market.” Arlette H. Uihlein, MD, FACP, FASCP, Vice President of Operations, Pathology Services, and Medical Director at Helomics added, “As the leading developer of mitochondrial DNA-based diagnostic tests, MDNA’s proprietary Mitomic Technology™ platform is uniquely positioned to mine mitochondrial DNA for unique biomarkers of disease. The identification of these mitochondrial DNA biomarkers in the blood of patients, and the validation of their clinical utility, will have a significant diagnostic impact across a wide variety of different disease states.”
Chris Mitton, President and CEO of MDNA, stated, “We are pleased to announce the availability of PMT™ as an LDT through the Helomics’ clinical lab. This is a key milestone for the commercial expansion of this novel test and for our proprietary Mitomic Technology™ platform. With a 97% negative predictive value for high-grade prostate cancer, PMT™ will have a significant impact on how prostate biopsy decisions are made moving forward, and we are excited to be working with Helomics to increase patient access to this technology in the U.S. This is the first of several proprietary liquid biopsy tests that we plan to commercialize leveraging the Mitomic Technology™ platform through our strategic collaboration with Helomics. Tests currently in development include a new groundbreaking liquid biopsy test for endometriosis, as well as blood-based tests for ovarian cancer and lung cancer.”
About Helomics® Corporation
Helomics® is an integrated clinical contract research organization whose mission is to improve patient care by partnering with pharmaceutical, diagnostic, and academic organizations to bring innovative clinical products and technologies to the marketplace. Helomics offers advanced clinical laboratory diagnostic tests as well as scientific and non-scientific product enhancement services to provide a customized solution to our client’s specific product development needs.
Helomics® is headquartered in Pittsburgh, Pennsylvania where the company maintains state-of-the-art, CLIA-certified, clinical and research laboratories. For more information please visit: www.helomics.com.
About MDNA Life Sciences
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. For more information, visit www.mdnalifesciences.com.