We’re pleased to announce that we have officially registered Peptest – a device for the diagnosis of reflux
disease – with the US Food and Drug Administration (FDA).
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.
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 is now registered at the FDA as a low-risk Class 1 Medical Device. You can
see the FDA entry on its website.
Professor Peter 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.”
We are also in the process of registering Peptest with the Chinese FDA, as well as Taiwan, Brazil and
Singapore. Peptest conforms to the European Directive 98/79/EC on in-vitro Diagnostic Medical Devices,
which is shown by the CE mark of conformity.