WEST PALM BEACH, FL / ACCESSWIRE / February 13, 2018 / MDNA Life Sciences today announced the results of a clinical study completed in collaboration with the University of Cambridge, UK, that have been published in the World Journal of Urology. The study reports the validation of a highly accurate blood-based biomarker for clinically significant prostate cancer for men with PSA levels within the PSA "grey zone." Based on the performance reported in the publication, MDNA's proprietary prostate biomarker has the potential to reduce the number of biopsies needed to diagnose significant prostate cancer with better accuracy compared to PSA screening.
This study is the first to report the detection of the 3.4 kb mitochondrial DNA deletion in plasma and validate a useful diagnostic threshold for the accurate detection of clinically significant prostate cancer for men in the PSA "grey zone" (PSA<10ng/ml). The diagnostic accuracy was defined in a cohort of 126 extremely well qualified samples from participants who underwent an MRI-guided repeat biopsy. The defined threshold was then tested against a second population of 92 men who were biopsy naïve at the time of blood collection. The accuracy of the 3.4 kb deletion using the defined threshold was very high (AUC 0.84-0.98, p<0.0001) and negative predictive values were between 97%- 100%.
The 3.4 kb deletion was discovered using MDNA's proprietary Mitomic Technology™ platform and has previously been profiled in prostate tumor tissue, in normal appearing cells present near a prostate tumor, urine, and serum. Extensive study of this deletion has demonstrated its close association with prostate cancer and its potential to enhance the current clinical pathway for prostate cancer diagnosis.
Chris Mitton, CEO of MDNA Life Sciences, says, "This test answers the vital need for a highly accurate, non-invasive prostate cancer test that is completely independent of PSA, age, family history, and algorithms. It is well known that the use of PSA for prostate cancer screening is limited by its low diagnostic accuracy. Showing that this deletion is so effective in screening blood from men with a clinical suspicion of prostate cancer is ground-breaking and represents a significant milestone in prostate cancer healthcare."
About the Mitomic Prostate Test™
MPT™ is a liquid biopsy test that measures the quantity of the 3.4 kb deletion circulating in blood. It is intended for use in men with clinical suspicion of prostate cancer to determine who is likely to have clinically significant cancer that may benefit from immediate intervention. Today's current standard of care for prostate cancer screening relies greatly on PSA levels, resulting in millions of men erroneously referred for prostate biopsy each year. MPT™'s high negative predictive value can identify those men who have a high probability of safely delaying or foregoing prostate biopsy due to an absence of significant cancer. MPT™ will be available as a reagent kit in both Research Use Only and CE-IVD format this year.
The blood test builds on the diagnostic capability of MDNA's earlier post-biopsy tissue test - the Mitomic Prostate Core Test - which accurately identifies men who could benefit from a repeat biopsy due to continued suspicion of prostate cancer following a negative biopsy. It also identifies men for whom a repeat biopsy may not be necessary.
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.
For further information, please contact:
Christopher Mitton
844-321-6362
c.mitton@mdnalifesciences.com
SOURCE: MDNA Life Sciences Inc.
