WEST PALM BEACH, FL / ACCESSWIRE / March 16, 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 being made available in Europe.
Launched in 2017, 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, (see https://link.springer.com/article/10.1007/s00345-017-2152-z).
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. 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 high 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. The kit is the first commercially available reagent kit to target the 3.4 kb mitochondrial DNA deletion and is manufactured in compliance with Good Manufacturing Practices (cGMP) in ISO 13485 & ISO 9001 certified facilities. Each kit contains all necessary reagents to process samples from up to 21 patient samples using a quick and simple workflow. The kit is available now in RUO form for licensee laboratories to conduct in-house validation studies and controlled testing. The CE-IVD version of the kit will be released in July.
"The launch of this kit is a very important milestone for MDNA. It will be instrumental in achieving our global distribution goals. We are confident that, through our distribution partners, the Mitomic Prostate Test will bring significant advances to the effective diagnosis and treatment of prostate cancer across Europe and more widely," said Chris Mitton, CEO of MDNA Life Sciences.
For more information, please visit www.mdnalifesciences.com.
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 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 further information, please contact:
Christopher Mitton
+1 844-321-6362
[email protected]
SOURCE: MDNA Life Sciences Inc.