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Clinical study for blood screening test begins

24th November 2017


Universal Diagnostics (UDX) has announced 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 five 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 two to three 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.”





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