The EDC is a global consortium between Abcodia, Cancer Research Technology and Cancer Research UK, the world’s leading charity dedicated to cancer research. The consortium, announced on the 6th June 2013, and aims to discover and validate blood-based biomarkers that may be used in cancer screening. Abcodia, through its exclusive commercial license, will provide access to longitudinal serum samples from the UKCTOCS?Biobank created by researchers at University College London. The programme aims to use best in class technology and engage with some of the world’s leading researchers and clinicians.
Thanks to earlier diagnosis and better treatments there have been many improvements in survival of some cancers such as breast, colorectal and cervical cancers. Despite these improvements, the survival rate for many other cancers has not improved. Finding cancer before it has metastasized often means that there are more options for treatment and better patient outcomes. Cancer screening is aimed at testing for cancer well before there are symptoms in people who are apparently healthy. A cancer screening blood test is ideal as they are relatively inexpensive, would be widely available and compliance with screening will increase.
A test that screens for cancer must be able to detect as many as many cancers as possible and, at the same time, not identify healthy people as having cancer. A poor test can lead to anxiety and unnecessary stress on healthy people. The rarer the cancer, the more difficult it is to develop a test that is accurate enough.
Harpal Kumar, CEO Cancer Research UK said, “The scope and scale of this alliance, aimed at developing new tests for a range of cancers at their earliest stage, before symptoms develop, is very exciting. The combination of expertise formed by this partnership provides a great opportunity to accelerate this vital biomarker research, which we hope will help save thousands of lives from cancer.”
The overall aim of the project to discover, verify and validate potential serum screening biomarkers, biomarker panels or statistical algorithms for common cancers that can be used for screening of either people at high risk of cancer or the population in general. Cancers with a high degree of unmet clinical need, for example lung cancer, are likely to be selected.
Once these validated biomarkers are identified the aim is to further test them in prospective studies and make them available for use in the UK and around the world.
It is expected that the project will have three main phases – discovery, verification and validation. Prior to commencing the discovery phase the partnership will conduct a pilot. The pilot aims to:
- Determine which cancers will be the focus of the collaboration
- Identify the most appropriate technology suited to testing for biomarkers in serum.
- Assessing and selecting technology partners who have the appropriate capability to support our endeavours.
Phase 1 is the discovery phase that aims to establish the best biomarker for each cancer for screening. We will select cohorts of longitudinal pre-diagnosis samples for each cancer type selected together with the appropriate numbers of controls. The sample set for each cancer will be tested on each technology platform including:
- DNA Methylation
- Tumour autoantibodies
- Other technologies such as glycans, exosomes etc.
At the end of phase 1, Abcodia, CRT and CRUK will jointly select the most promising markers and technology to take forward to the verification phase.
Phase 2 will verify the new biomarkers in terms of their sensitivity and conduct specificity studies using potentially confounding diseases. At the end of the phase we will be seeking commercialisation partners who have the capability to develop production ready assays and validating these assays in defined sample sets to ensure reproducibility.
The phase 3 validation study is focussed on confirmation of the biomarker performance using the production ready assays and creating data packs in support of CE marking and other regulatory approvals.