MDNA Life Sciences Announces the Availability of the CE Marked Mitomic(R) Prostate Test Real-Time PCR Kit
Tuesday, October 9, 2018 12:30 AM
WEST PALM BEACH, FL / ACCESSWIRE / October 9, 2018 / MDNA Life Sciences Inc. (MDNA), the molecular diagnostics company revolutionizing the development of liquid biopsy biomarkers based on the mitochondrial genome, announced today that the Mitomic® Prostate Test (MPT™) Real-Time PCR Kit is now CE marked and being made available worldwide.
MPT™ is a liquid biopsy test optimized for the early detection of prostate cancer in advance of biopsy and is independent of PSA and age. The unrivaled accuracy of the test has been illustrated in the results of the clinical study carried out in collaboration with the University of Cambridge, UK, that were published in the World Journal of Urology in December 2017 titled "A single mitochondrial DNA deletion accurately detects significant prostate cancer in men in the PSA grey zone".
Today's current standard of care for prostate cancer screening relies greatly on PSA levels, resulting in millions of men erroneously being referred for prostate biopsy. With a 92% Sensitivity, MPT™ is designed for testing men with clinical suspicion of prostate cancer to determine who is likely to have clinically significant cancer that may benefit from immediate intervention. MPT™ also has a >99% negative predictive value which can identify those men in whom there is an absence of significant cancer and who therefore can safely delay or forego biopsy.
The kit is designed for use on real-time PCR platforms which are widely used in clinical laboratories throughout the world. MPT™ targets the 3.4 Kb mitochondrial DNA deletion and is the world's first commercially available non-PSA linked RT-PCR kit for the detection of clinically significant prostate cancer in blood plasma. Now available in both RUO and CE-IVD formats, each kit contains all necessary reagents to process samples from up to 21 patient samples using a quick and simple workflow. MDNA has already licensed kit distribution rights to several soon to be announced commercial partners in strategic territories around the world and is actively seeking additional distributors in select markets to further expand on the existing network.
"The launch of this kit marks another key milestone for MDNA as we continue to execute on our global distribution strategy. We are excited that through our growing network of international distribution partners, MPT™ will bring significant advances to the effective diagnosis and treatment of prostate cancer worldwide." said Chris Mitton, CEO of MDNA Life Sciences. "The global roll-out of the CE marked MPT™ kit will enable rapid implementation in molecular laboratories and offer unprecedented clinical access to this novel, ground-breaking biomarker."
About MDNA Life Sciences Inc.
MDNA Life Sciences, Inc. - www.mdnalifesciences.com - 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 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. Following the successful development of the prostate test, work on tests for endometriosis and ovarian cancer is at an advanced stage and biomarkers have been identified for other cancers such as lung, breast, uterine, cervical, bladder, colorectal, and melanoma.
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SOURCE: MDNA Life Sciences Inc.