Hull medical tech firm’s reflux device set for US launch

Hull-based medical tech company RD Biomed has officially registered a device for the non-invasive diagnosis of reflux disease with the US Food and Drug Administration (FDA) ahead of its launch in the country this year.

Peptest is a non‑invasive, diagnostic medical device that contains antibodies for detecting the stomach enzyme pepsin in clinical samples, such as saliva or sputum.

Peptest was created by renowned gastrointestinal specialist Professor Peter Dettmar, director of Hull-based RD Biomed and the former global research and development director in gastrointestinals for Reckitt Benckiser Healthcare.

Because pepsin should only be found in the stomach, if it is found in the oesophagus, the throat, the mouth or the lungs – then it has been refluxed. Evidence shows that compared to acid alone, pepsin is very damaging to the oesophagus and laryngeal tissue.

Before any medical device can be sold for clinical use in the United States, it must first meet the FDA’s regulatory standards. Peptest and RDBiomed have now been registered at the FDA as a low-risk Class 1 Medical Device.

Professor Dettmar said: “We’re delighted that Peptest is now registered with the Food and Drug Administration in the US. The launch of Peptest in this market is an important step in our journey. It is estimated that reflux disease affects more than 18 million people in the United States – including babies up to the older generation – and is the most common gastrointestinal disorder.”

“Quite often when patients describe symptoms, such as heartburn or indigestion, they are recommended a course of proton pump inhibitors without a definitive diagnostic procedure. Or they are sent for one or more of a series of very invasive diagnostic tests, such as endoscopy.”

“With Peptest, all patients need to provide is a saliva/sputum sample that they just spit into a collection tube for to be analysed, so it’s pain-free, low-cost and easy to administer. We’ve undertaken many clinical studies to demonstrate the accuracy of Peptest – it has high sensitivity and specificity – and believe it can help patients get a diagnosis of reflux much more quickly and can therefore get onto an appropriate treatment regime or a lifestyle regime faster.”

RD Biomed is also in the process of registering Peptest with the Chinese FDA, as well as Taiwan, Brazil and Singapore.

Close