Summary
Gastro-oesophageal reflux disease (GORD/GERD), where stomach acid enters the oesophagus, affects 10-20% of the population. There is currently no method available to test for GORD in a primary care setting. Of particular difficulty is testing for extra-oesophageal reflux where acid reflux travels into the airway space and can cause airway problems such as exacerbated asthma and chronic cough. A blanket approach of prescribing anti-reflux medication, with many unwanted side-effects, is often performed in the absence of an accurate diagnosis. Our simple device has potential to alter the treatment pathway. Based upon simple principles that stomach acids entering the mouth can erode and eventually destroy the teeth, we have developed a small disc-shaped device which can be reversibly attached to a back tooth and left in situ for up to one week. A colour change after a number of days would indicate whether or not there has been stomach acid exposure. This low cost, biocompatible technology has been developed by a team of dentists, gastroenterologists and chemists who are keen to help get this technology adopted clinically.
What
King’s Dental Researchers, and their team of clinicians and scientists have created a simple new device based upon the unmet need to identify problematic reflux in a minimally invasive manner. The small composite material technology, reversibly attaches to a tooth/denture and dissolves at a set rate in the presence of different levels and types of acid exposure, thereby diagnosing the presence and activity of stomach acid reflux. This easy to use and cost-effective test is non-invasive once fitted and will represent a significant step change in the diagnosis and management of extra-oesophageal reflux disease. With potential to be applied in any primary care setting or used by specialists, it will be a much-needed adjunct in treatment decisions and care.
Why
Gastro-oesophageal reflux disease (GORD) when undetected is potentially painful and may result in cancerous changes if not treated/managed. When stomach acid enters into the mouth and airway it can exacerbate lung conditions such as asthma, chronic cough and obstructive pulmonary disorders. Yet to date, there is no primary care test. If the patient is lucky enough to experience gastric symptoms to signpost their GP as to the route of the problem, the test is invasive and expensive, requiring placement of a pH probe down the throat and leaving it there for 24 hours to assess acid activity. For this reason, patients are often placed on medications (proton pump inhibitors) without any prior testing. These medications are not without side effects. As the stomach acid can destroy the teeth, dentists have been able to inform patients that there is significant acid activity and recommend testing/management. This ability of stomach acid to erode biomaterials is the feature upon which the innovation is built and has potential to revolutionise the primary care management of acid reflux disease
Opportunity
A priority patent application was filed in the UK, followed in Sept 2020 by an International PCT
Application. Funding is in place to develop a prototype further, and the researchers are currently seeking commercial partners to help us develop this product fully and bring the technology to market. We have a range of supportive dentists, gastroenterologists and respiratory consultants who may aid in prototype testing and evaluation. A prospective development partner could take an option to a licence over the patent and associated know-how and exclusivity would be available for a suitable partner.
Patent Status
A priority patent application was filed at the UK IP Office (Priority date: 12 September 2019) and this
was followed on 11 Sept 2020 by an International PCT Application (PCT/EP2020/075533).
The PCT Application is published with an International Search Report as WO2021/048396, 18 March 2021
KCL Principal Investigators
Dr Saoirse O’Toole & Dr Garrit Koller
Faculty of Dental, Oral and Craniofacial Sciences, Centre for Clinical, Oral and Translational Sciences, Guy’s Hospital, London, UK