Cancer Research Technology (CRT), Cancer Research UK’s commercial arm, and Varleigh Dx (UK) Ltd, a clinical diagnostics development company, have jointly launched a new test as an aid in the diagnosis of patients with pancreatic cancer.
This test is now CE marked, conforming to the European IVD Directive.
The launch coincides with research published in the British Journal of Cancer showing that the test, which detects a protein called MCM5 involved in cell replication, can aid in the diagnosis of pancreatic cancer, supporting traditional cytological methods. The test is performed on samples which are routinely taken as part of the current pancreatic cancer management pathway.
Standard cytology tests, which look at cells collected from the tumour are sometimes not sufficiently sensitive to provide an accurate diagnosis. Often several repeat procedures are required to obtain a definitive diagnosis. The researchers showed that using the MCM5 test alongside standard cytology testing helped support the diagnosis of patients who had received unclear results from repeat cytological tests***.
The new laboratory test uses a simple colourimetric test to measure the concentration of antibodies bound to the MCM5 protein, which is present at higher levels in cells that are dividing rapidly, such as those found in malignant tumours.
Clive Richardson, Director of Varleigh Dx said: “This test for pancreatic cancer is the first of a number of new tests for MCM5 technology that we are developing to assist in the early detection of cancer.”
The rights to commercialise the MCM5 assay – also known as the ELISA test – were licensed to Varleigh Dx by CRT after the protein biomarker was first identified as a cancer biomarker by Cancer Research UK-funded researchers at the University of Cambridge.
Professor Nick Coleman, who lead on this earlier work, added: “It’s great news that our research has led to new routes to translate these biological markers into ways to improve early diagnosis, for such an aggressive cancer.”
Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: “It’s always hugely satisfying to see discoveries originally made in the lab by Cancer Research UK scientists and licenced by CRT now reaching the stage where they can benefit patients and we’re delighted to have worked with Varleigh Dx to have made this possible.
“This should mean that more patients with this aggressive form of cancer can be diagnosed at the earliest possible stage, without having to undergo multiple invasive procedures.”
Diagnosis of pancreaticobiliary malignancy by detection of minichromosome protein 5 in biliary brush cytology, Keane et al, British Journal of Cancer, advance online publication 12 January 2017
This press release was amended on 22.10.18 to reflect test availabilty.
Published as part of the ongoing outputs of the TRANSBIL research programme lead by Prof Steve Pereira, Consultant Gastroenterologist/Hepatologist (UCLH and Royal Free Hospital) & Professor of Hepatology & Gastroenterology (UCL).
* The study followed 97 patients at University College London Hospital (UCLH) or the Royal Free Hospital (RFH), London all of whom had endoscopies. Of the 97 patients 29 had an established diagnosis of malignant strictures (narrowing of the bile duct) which is commonly caused by pancreatic cancer and 68 patients were new referrals with an indeterminate diagnosis. The additional ELISA test was found to be significantly more sensitive than brush cytology in detecting malignancy and showed that 50 of the 97 patients had malignant strictures associated with the cancer.
This work was funded in part by the Medical Research Council, and supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre.