On January 16, 2017 Cancer Research Technology (CRT), Cancer Research UK’s commercial arm, and Varleigh Dx (UK) Ltd, a clinical diagnostics development company, reported they have jointly launched a new test as an aid in the diagnosis of patients with pancreatic cancer (Press release, Cancer Research Technology, 16 16, 2017, View Source [SID1234523173]).
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This test is now CE marked, conforming to the European IVD Directive, and available for diagnostic use across the UK*.
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Cancer Research Technology’s director of business development, said: "It’s always hugely satisfying to see discoveries originally made in the lab by Cancer Research UK scientists and licenced by CRT now reaching the stage where they can benefit patients and we’re delighted to have worked with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."