New Blood Test to Accurately Detect the Presence of Clinically Significant Prostate Cancer Now Available

WEST PALM BEACH, FL / ACCESSWIRE / July 16, 2019 / Today, MDNA Life Sciences announces that its breakthrough Mitomic^® Prostate Test (MPT^TM) – 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 cancer[1]) – 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 study[2] carried out in collaboration with University of Cambridge shows that the MPT™ biomarker has a higher than 99% negative predictive value. 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% sensitivity³, 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 MPT^TM 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.”

For further information on the test and its availability in the UK please visit www.mitomic.co.uk.

About prostate cancer and how it is diagnosed:

The prostate is a small gland in the pelvis located between the penis and the bladder[4]. The risk of developing prostate cancer depends on multiple factors, including age, genetics, family history, lifestyle and other medical conditions[5]. Worldwide, there were 1,094,916 cases of prostate cancer and 307,481 deaths recorded in 2012[6]. In the UK, prostate cancer is the most common cancer in men, particularly in older men⁵. Approximately one in eight men will get prostate cancer in their lifetimes⁵ and more than 11,000 men in the UK die from it each year[7].

A Prostate Specific Antigen (PSA) test can help diagnose prostate problems, including indications of prostate cancer, by determining the level of PSA in the blood[8]. A high PSA level can indicate the presence of cancer, but PSA can also be raised by conditions unrelated to cancer⁸ If PSA test results and a rectal examination suggest a risk of prostate cancer, a prostate biopsy, often preceded by an MRI scan, may be carried out.

The term ‘PSA grey zone’ is used to refer to a range of PSA results above which a strong recommendation to proceed to biopsy would be likely and below which it would be unlikely. It is the uncertainty of the grey zone which leads to a high number of biopsies being carried out on patients who do not have significant prostate cancer[9].

About mitochondrial DNA

Many diseases have their own unique biomarkers, like fingerprints, which are ‘red flag’ proteins, substances or pieces of DNA that are only detected when someone has that particular disease.

Inside every cell in our body are lots of tiny structures called mitochondria, which produce the energy needed to power the cell’s various functions. These tiny ‘batteries’ contain their own unique DNA made up of the genes they need to function properly, called mitochondrial DNA.

Mitochondria contain thousands of copies of mitochondrial DNA, and when cells are damaged some of these copies become mutated. These mutations are unique and disease-specific, making them ideal biomarkers.

The presence of these mitochondrial DNA biomarkers can be used to detect diseases, even in the early stages, because if the disease is present there will be multiple copies of the biomarker detectable in cells. This provides an exceptional opportunity to accurately detect diseases, catching them early enough when treatment is most effective, improving and saving millions of lives every year.

About MDNA Life Sciences

MDNA Life Sciences, Inc. is a leading developer of molecular diagnostic tests using its proprietary Mitomic^® Technology platform that exploits the unique biological characteristics of mitochondrial DNA. This innovative system is highly effective 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 research team at MDNA’s Newcastle upon Tyne laboratory have identified biomarkers associated with a range of different types of cancer including prostate. A study³ carried out in collaboration with University of Cambridge on the clinical performance of the MPT™ biomarker showed that it accurately detects the presence of clinically significant prostate cancer in men in what is known as the PSA grey zone^3,4, and also has a near 100% negative predictive value³ which means that it can readily identify cases where there is no clinically significant cancer.

The company is applying its expertise in mitochondrial genomics to develop an extensive proprietary portfolio of blood-based molecular tests for conditions that currently rely on either poor and potentially inaccurate testing methods or invasive procedures for detection. As well as the newly released test for prostate cancer, MDNA recently announced plans to launch the world’s first blood test for endometriosis in a little over 6 months from now. The company is also planning to complete development on tests for ovarian cancer and lung cancer in 2020. Tests for pancreatic, liver, and stomach cancers will follow in 2021 and 2022 and tests for testicular, breast, uterine, cervical, bladder, colorectal cancers, and melanoma are in the pipeline.

To enable the tests to be used clinically on a widespread basis, a CE-marked reagent test kit has been developed. MPT™ is the world’s first non-PSA linked test to be made available in real-time PCR (polymerase chain reaction) kit format. The kit is designed for use with 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.

MDNA is a commercial partner in the Re-IMAGINE project – www.reimagine-pca.org – funded by the Medical Research Council and Cancer Research UK. 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.

For further information about MDNA Life Sciences, its Mitomic^® Technology and the new Mitomic^® Prostate Test please visit: www.mdnalifesciences.com.

About Aspire Pharma Ltd.

Founded in 2009, Aspire Pharma Ltd is a British pharmaceutical company supplying a mix of innovative branded and generic pharmaceuticals, medical devices, OTC products and diagnostics, across multiple therapeutic classes. Recently listed as one of the top ten fastest growing companies in the sector, Aspire Pharma products continue to provide significant clinical solutions for UK patients, while delivering meaningful economic benefits for the National Health Service. For further information on Aspire Pharma, its vision, people and products, visit www.aspirepharma.co.uk, info@aspirepharma.co.uk or phone +44 (0)1730 231148.

Notes to Editors:

For further information, interview/comment opportunities, to film or visit the research laboratory in Newcastle Upon Tyne and high-resolution images/illustrations please contact MDNA Life Sciences press office, Say Communications:

• Nina Vadjaraganian, 020 8971 6408, nina@saycomms.co.uk
• Roisin McDonough, 020 8971 6413, rmcdonough@saycomms.co.uk

References

[1] Defining clinically significant prostate cancer on the basis of pathological findings. https://www.ncbi.nlm.nih.gov/pubmed/30565298

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