SEVILLE, Spain & LONDON--(BUSINESS WIRE)--Universal Diagnostics (UDX), an innovative biomedicine company focused on screening tests for the early detection of cancer, announced today the start of a prospective clinical study of its colorectal screening blood test in collaboration with Imperial College Healthcare NHS Trust (London, UK). The aim of the Metabolic biomarkers for Early Colon cancer and advanced AdeNOma (MECANO) study is to confirm the effectiveness of the test in detecting the presence of colorectal cancer at an early or pre-cancerous stage (adenoma), and further improve the positive results achieved to date. About 94% of patients with colorectal cancer live 5 years or more when the disease is detected at stage 1. UDX’s screening test combine metabolomics (changes made to the body’s metabolism due to cancer) with bioinformatics to differentiate cancer and adenoma (pre-cancerous) patients from healthy individuals. By detecting early, there is a better chance of disease prevention and cure. Unlike current fecal screening tests and colonoscopy, the UDX test has been designed to offer a simple to use, cost-effective alternative for large-scale colon cancer screening.
“As with many cancers, it’s vital to catch colorectal cancer early, ideally at the pre-cancerous adenoma stage, to enable effective treatment and provide greater chance of survival for the patient. However, only about a quarter of cases are caught in the very early stages, mostly due to lack of cost-effective screening. This means there is a great need for a simple to use, non-invasive and accurate test that can be used to screen great numbers of people to detect cancers earlier,” explained lead investigator Dr. James Kinross, consultant colorectal surgeon at St. Mary's Hospital, Imperial College Healthcare NHS Trust. “Research conducted at Imperial College London and the National Phenome Centre has shown that metabolomics can play a vital role in early detection of cancer. We look forward to combining our expertise with UDX with the ultimate aim of benefitting cancer patients.”
A network of seven hospitals in London (St. Mary’s Hospital, Charing Cross Hospital, Hammersmith Hospital, Chelsea and Westminster Hospital, Royal Marsden, West Middlesex Hospital and St. Mark’s Hospital) will collect approximately 660 blood samples from people, aged 55-74, who have been referred by their GPs for colonoscopy due to a positive result from the faecal screening test. Following testing by UDX, the results will be used to confirm the current biomarker panel and potentially add additional biomarkers to further increase the sensitivity and/or specificity of the test. When approved, a positive test result would suggest the probability that the patient has colorectal cancer or adenoma is high. These patients would then be referred for a colonoscopy for confirmation. A negative test result suggests that the probability of colorectal cancer is very low and the patient should return for a follow up test in 2-3 years.
“This clinical study for our colorectal cancer screening test, in partnership with Imperial College Healthcare NHS Trust, is a key milestone for Universal Diagnostics,” stated Juan Martínez-Barea, Co-Founder and CEO of Universal Diagnostics. “On the one side, the study strengthens our international efforts to collect blood samples from different sources to develop our test. On the other, we are optimistic it is the first step that will generate great benefits for patients and physicians worldwide.”
People interested in participating in the study can contact study coordinator, Afeez Adebesin, (a.adebesin@imperial.ac.uk) for more details.
About the Colorectal Test
UDX’s first product is a simple, non-invasive, accurate and inexpensive blood-based screening test to detect early stage colorectal cancer and adenoma, allowing early detection and cancer prevention. Using profiling of metabolic small molecules that have been altered by the presence of cancer, UDX has identified and quantified a proprietary panel of biomarkers that enables differentiation of colon cancer and adenoma patients from healthy individuals. Based on research using more than 2,400 samples, UDX’s colorectal test exhibited 87% sensitivity for colorectal cancer and 83% sensitivity of adenomas.
About Universal Diagnostics
Universal Diagnostics (UDX) is an innovative biomedicine company focused on early detection of cancer. By combining world-leading expertise in metabolomics with advanced bioinformatics, UDX is developing simple to use, non-invasive tests to detect cancers early. The first test in development is for the detection of colorectal cancer and precancerous adenomas. Further details can be found at http://www.universaldx.com.
