MDNA Life Sciences has announced that its breakthrough Mitomic® Prostate Test (MPTTM) – the world’s most accurate blood test to determine whether a man does or does not have prostate cancer that requires treatment (clinically significant prostate cancer1) – is now available for clinical use with the launch of the test in the UK by MDNA’s partner, Aspire Pharma Ltd.
The new test takes advantage of the unique characteristics of mutations in mitochondrial DNA as biomarkers which can signify the presence of clinically significant prostate cancer. A clinical study2 carried out in collaboration with the University of Cambridge shows that the MPT™ biomarker has a higher than 99% negative predictive value.2 This means that men with a negative MPT™ result can therefore safely delay or avoid further diagnostic tests, as they are highly unlikely to have clinically significant prostate cancer. MPT™ also has a 92% sensitivity,2 which means that men with a positive MPT™ result can be referred for immediate medical intervention.
Dr Nikhil Chopra, Education Secretary for the Primary Care Urology Society says, “Until now, prostate cancer has been challenging to diagnose and current methods of diagnosis have limitations that create uncertainty. A simple blood-based test that can provide more accurate and certain information regarding the decision to undergo biopsy, is a welcome addition and may go some way to reducing one of the problems we face of over diagnosing low grade tumours. In the type of patient for whom this test is aimed, those with elevated PSA but no clear evidence of high-grade disease, we could positively impact how we diagnose and differentiate those prostate cancers which require treatment, from those which do not.”
Prostate cancer testing is heavily reliant on measuring Prostate Specific Antigen (PSA) levels, which can give notoriously high false-positive results. Only 25% of men who have a biopsy following elevated PSA levels are found to have prostate cancer.3 This leads to millions of men being wrongly referred for a prostate biopsy. The MPTTM can help to reduce the number of prostate biopsies by up to 30%.
Dr Andrew Harbottle, MDNA Life Sciences’ Chief Science Officer explains: “We exploit the unique characteristics of mutations in mitochondrial DNA, which can act as biomarkers, providing us with a unique and detailed diary of damage to the DNA. This enables us to accurately detect many difficult to diagnose diseases and conditions, such as prostate cancer. Just as importantly, the ability of our Mitomic® Prostate Test to determine that clinically significant cancer is not present can help to significantly reduce the number of prostate biopsies required, thus saving costs in the health system and reducing stress and discomfort for many men.”
The test will initially be available privately, for self-funding patients, through private healthcare clinics with testing and result reporting being handled at HMR Labs in London. Aspire Pharma are actively undertaking work with the NHS on a longer-term plan to make the test available more widely.
Graham Fraser-Pye, Managing Director of Aspire Pharma says, “We take great pride in the fact that we are working alongside MDNA Life Sciences to bring this exciting new test to the UK market. Diagnosis of prostate cancer has, until now, been lagging behind other cancers and we believe that with the launch and subsequent further use of this test, that will no longer be the case.”
Harry Smart, MDNA Life Sciences’ Chairman adds, “We are the only company to use mitochondrial DNA to detect diseases such as cancer and have developed a library of 16,000 biomarkers to date. Our test for prostate cancer is highly accurate. It is the best performing prostate cancer blood test in the market and will fundamentally change the way this disease is detected and diagnosed. In parallel with the launch of MPT™ in the private health sector, plans are under way to make it available in the NHS.”