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New optical bowel cancer test improves diagnosis

In collaboration with the NIHR, the Dutch-based medical technology company SpectraScience developed the WavSTAT4 Optical Biopsy System® for the real time diagnosis of pre-cancerous colon polyps.

Published: 06 June 2019

The test for pre cancerous colon polyps

SpectraScience is a U.S. and Dutch-based medical technology company. It focuses on cancer diagnosis, specifically the early detection of colorectal cancer (cancer in the lower bowel) using a light-based technology.

By achieving more accurate and earlier diagnosis, SpectraScience’s vision is that more patients will be diagnosed at a stage where their disease can be effectively treated, improving outcomes for patients and reducing overall treatment costs.

Colorectal cancer study

The MORDIS study (Multicentre, Open, Prospective Study on Modified Resect and Discard Strategy of Small Colonic Lesions) tested the WavSTAT4 Optical Biopsy System. This is an automated diagnostic tool which uses light at a specific wavelength to predict during colonoscopy, whether polyps are non-suspect or suspect.

Benign polyps, also called ‘non-suspect polyps’, would generally not be removed but cancerous/pre-cancerous polyps, known as ‘suspect polyps’, must be removed. However, during screening it can be difficult to tell the difference between the 2 types, which leads to the removal and subsequent laboratory testing of many tissue samples. This extensive sampling is often impractical, time-consuming and costly.

Results from using the WavSTAT4 Optical Biopsy System

Preliminary results of the study indicate that WavSTAT4 is highly accurate (96%) in predicting when a polyp is non-suspect. 

This means that during screening for bowel cancer, fewer polyps would need to be removed, saving both time and resource in terms of clinician time and laboratory testing.

NIHR support

The study was first brought to the attention of the NIHR when the company contacted the NIHR to find out about collaboration opportunities.

As part of our industry service, we can introduce companies to a full range of experts who can collaborate on clinical research and help develop a potential therapeutic or technology for use in a clinical setting.

The range of experts includes:

  • clinicians
  • laboratory scientists
  • health economists
  • statisticians
  • methodologists
  • biomedical engineers
  • world-leading experts and specialists in a range of therapeutic areas

We connected SpectraScience with Dr Venkat Subramanian, who works within an NIHR Surgical MedTech Co-operative in England. Dr Subramanian collaborated with SpectraScience to help translate the light-based technology into the clinical setting and develop a feasible study protocol.

Study Support Service

The study opened in February 2015 at St James’ University Hospital, Leeds. Our Study Support Service assisted study set-up by helping the company to obtain the relevant research and development permissions.

We also supported study delivery by allocating a clinical trial assistant to support (funded by the company) Dr Subramanium with administration of the study for one day a week. This included screening clinic patient lists to identify patients that might be suitable and that would benefit from taking part in the MORDIS study.

This support contributed to the overall success of the study. The UK recruitment target was to recruit 100 patients. When MORDIS closed as planned in August 2016, a total of 122 patients had taken part which equates to 122% of the recruitment target.

“It was extremely helpful to have the services of NIHR connect us with Dr Subramanian. With their help we were able to conduct our clinical evaluation with investigators who are both influential and engaged with improving the state of cancer diagnostics to benefit NHS patients. Their knowledge and professionalism was critical to our success.”

Michael Oliver, President and CEO of SpectraScience

NHS impact

Dr Venkat Subramanian, Chief Investigator of the study and Clinical Associate Professor and Honorary Consultant Gastroenterologist at the University of Leeds, said:

“Further work will be needed to assess potential cost savings for the NHS, as well as how well this technology enables clinicians and endoscopists in diverse settings to set appropriate follow up schedules for patients with colorectal polyps detected during colonoscopy.

“Further UK trials are also likely to be required to ensure the technology can be used effectively by the different kinds of endoscopy centres that exist in the UK.”

Contact the NIHR industry team

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