MDNA Life Sciences Inc. (MDNA), the molecular diagnostics company revolutionizing the development of liquid biopsy biomarkers based on the mitochondrial genome, announced today the that the Mitomic® Prostate Test (MPT™) is ready for release in the UK.
Developed at MDNA’s research facility in Newcastle upon Tyne, 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 unrivalled accuracy of the MDNA biomarker has been illustrated in the results of a clinical study carried out in collaboration with Cambridge University that were published in the World Journal of Urology earlier in the year. The study – “A single mitochondrial DNA deletion accurately detects significant prostate cancer in men in the PSA ‘grey zone'” – can be seen at https://link.springer.com/article/10.1007/s00345-017-2152-z.)
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. This represents a major advance on the current standard of care for prostate cancer screening which relies greatly on PSA levels, which are widely acknowledged as being unreliable, and results in many men being erroneously referred for prostate biopsy. MPT™ has 92% sensitivity – which is the measure of accuracy in detecting the presence of cancer and therefore giving more confidence to a decision to proceed to biopsy – and a negative predictive value approaching 100% – which is the measure of accuracy for identifying patients in whom there is an absence of significant cancer and who therefore can safely delay or forego biopsy altogether.
The test will be carried out using MDNA’s proprietary CE-IVD kit. MPT™ is the world’s first non-PSA linked test to be made available in real-time PCR kit format and delivers unparalleled performance in the early detection of clinically significant prostate cancer. The kit is designed for use with real-time PCR platforms that are widely used in clinical laboratories throughout the world. Each kit contains all necessary reagents to process up to 21 patient samples at a time using a quick and simple workflow.
Available initially by GP referral, the ultimate goal is that the test should be offered through the NHS as a screening test to reap maximum benefits for patients from early detection and to achieve significant cost savings from elimination of unnecessary biopsies.
“Given the Prime Minister’s announcement last week about the initiative to improve early diagnosis of cancer, the launch of the Mitomic® Prostate Test is very timely. We are confident that our test will bring significant advances to the effective diagnosis and treatment of prostate cancer in the UK,” said Harry Smart, Chairman of MDNA Life Sciences. “Preparation for the launch of the test through our distribution partner in the UK is currently underway.”
About MDNA Life Sciences Inc.
MDNA Life Sciences, Inc. – www.mdnalifesciences.wip – 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.
MDNA is a participant in the Re-IMAGINE project funded by the Medical Research Council and Cancer Research UK under the Chairmanship of Professor Mark Emberton, Dean of Medical Sciences at University College London. The project will combine the underlying molecular changes in the cancer with state-of-the-art imaging. This will allow the prediction of prostate cancer status for the individual (low, medium or high risk) without recourse to biopsy. It will also allow prediction of which prostate cancers are likely to progress over time and which are not, this has largely eluded scientist so far. By doing so, men will be subject to fewer but better biopsies, improved risk stratification, appropriate treatment allocation, more benefit, less harm and more cost-effective care. This will allow the prediction of prostate cancer status for the individual (low, medium or high risk) without recourse to biopsy.
MDNA 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 a test for endometriosis is at an advanced stage and work on a test for ovarian cancer is under way. Biomarkers have been identified for other cancers such as lung, testicular, breast, uterine, cervical, bladder, colorectal, and melanoma.
Link to intro video: https://youtu.be/vPaBP41LXN0
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SOURCE: MDNA Life Sciences Inc.