A UNIQUE BLOOD TEST FOR CANCER

Oncascan Limited is developing a unique type of blood test for cancer which, used in conjunction with existing methods of screening and diagnosis, could greatly improve their overall performance. Specifically this improved performance would lead to far fewer unnecessary invasive follow up procedures.

Adopting the new test could result in widespread multiple benefits:

  • for patients (reduced stress, risk or discomfort arising from interventions);
  • for clinicians (greater speed and accuracy of diagnosis); and
  • for health service providers (substantial cost savings, accessing social groups at risk of late presentation).

In short this is a novel "rule out" test for cancer and initially we are focusing on two major application areas - bowel cancer and prostate cancer.

WHAT IS THE TEST?

Known as the lymphocyte genome sensitivity (“LGS”) test, it is based on a discovery and an invention both made at the University of Bradford, Yorkshire, England. The discovery is that the genome of lymphocytes of cancer patients, even at an early stage of the disease, is subtly different from that of healthy individuals. The invention is a practical way to measure this difference.

Oncascan Limited holds an exclusive worldwide licence to the patents and know-how associated with the lymphocyte genome sensitivity invention.

HOW WILL THE LGS TEST BE USED IN PRACTICE?

Work so far indicates that the LGS Test has the ability to indicate, with a high degree of certainty, that a given patient does NOT have cancer. For the reasons given below we have decided to focus its initial application on bowel cancer and prostate cancer. Other applications are likely to follow later.

In England, a large percentage of people, referred to a hospital consultant by their GP with suspected bowel cancer, will be given a colonoscopy (which is an excellent diagnostic tool). However only quite a small proportion of these people will actually have cancer (or polyps that require removal). If colonoscopies were restricted to those with an LGS score above an appropriate cut off, a large number of unnecessary interventions could be avoided whilst still ensuring that patients who would benefit from the procedure were so treated.

The situation with prostate cancer is analogous. Men referred to a specialist by their GP will need to make an informed decision whether to have a prostate biopsy or not. Such biopsies are not that pleasant and carry an infection risk (about 3%). If the LGS Test was given at an early stage of the investigation then a significant proportion of patients (ie those with a low LGS score) could decide with confidence not to proceed with a biopsy. Conversely those with a high score who subsequently had a negative biopsy might well be advised to have a re-biopsy. We aim to find out what these proportions are by carrying out a trial at two Yorkshire hospitals starting in the second quarter of 2015.

WHAT HAS BEEN ACHIEVED SO FAR?

During 2012 and 2013 the assay was refined, improved and tested in laboratory conditions. By the end of 2013 it was clear that the data was very promising and that the test was ready for hospital evaluation.

In February 2014, Oncascan was awarded an SBRI Healthcare Phase 1 development contract funded by NHS England to carry out an evaluation of the predictive power of the LGS Test on a cohort of patients referred for bowel cancer investigation at Bradford Royal Infirmary. Anonymised blood samples from 300 volunteers have now been taken and are being analysed and compared with the diagnosis arising from their normal NHS investigation. Preliminary results show that the LGS Test can safely predict a very worthwhile proportion of "unnecessary" colonoscopies.

In October 2014, Oncascan and the University of Bradford were jointly awarded a grant from Innovate UK (formerly the Technology Strategy Board) for a collaboration project to carry out an evaluation of the LGS Test on a cohort of patients referred by their GP for prostate cancer investigation. This study is due to start in April 2015.

The potential benefits of using the LGS Test to reduce unnecessary colonoscopies are very considerable. Having quantified the benefits by the Phase 1 evaluation described above, SBRI Healthcare awarded Oncascan a Phase 2 development contract for one year starting in January 2015. The objective of this contract is to demonstrate how the LGS Test can be carried out reliably on a larger scale and at a much reduced cost. Currently the assay is largely manual, requires particular skills and can only be performed for a small number of samples at a time. It is thus essential that automated methods are developed. We have clear ideas how to achieve this goal. It is our priority for 2015.

WHAT NEXT?

In the short term the company will concentrate on:

  • completing the bowel cancer evaluation by March 2015;
  • starting the prostate cancer evaluation in April 2015; and
  • developing and proving the technologies that will allow the test to be automated.

The SBRI Healthcare contracts and Innovate UK grant awarded in 2014 have given the company an enormous boost and have provided vital resources and access to contacts. With this firm foundation in place, Oncascan will be seeking external equity investors in 2015 to secure the next stages of the company's development.