The blood test is intended to identify individuals with clinically significant prostate cancer or those who require treatment. It analyses mitochondrial DNA as biomarkers to determine whether a man has or does not have the cancer.
The Mitomic Prostate Test works as a qualitative in-vitro polymerase chain reaction assay to detect the 3.4 kb mitochondrial DNA deletion and the 18S rRNA nuclear DNA sequence.
Commonly, prostate cancer is diagnosed based on Prostate Specific Antigen (PSA ) levels, which is said to be associated with high false-positive results.
MDNA Life Sciences noted that only 25% of men who undergo a biopsy after finding increased PSA levels have prostate cancer. This leads to unnecessary prostate biopsy procedures in many individuals.
The company expects the new test to help minimise the number of prostate biopsies by up to 30%.
MDNA Life Sciences chief science officer Dr Andrew Harbottle said: “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.”
In a clinical study conducted in alliance with the University of Cambridge, the MPT biomarker demonstrated a higher than 99% negative predictive value.
This is expected to delay or eliminate the need for additional diagnostic tests in individuals with a negative MPT result, as they are considered to be highly unlikely to have clinically significant prostate cancer.
The test was also found to have 92% sensitivity, allowing men with a positive result to be referred for immediate medical intervention.
Initially, the Mitomic Prostate Test will be available through private healthcare clinics. HMR Labs in London will handle result reporting for the test. Aspire Pharma is working with the NHS to expand the test’s availability.