FDA News

Saliva-based GERD test registered with FDA, will launch in US this year

RD Biomed has registered Peptest, a noninvasive device that diagnoses GERD by using antibodies to detect the gastric enzyme pepsin in saliva, sputum or exhaled condensate samples, as a low-risk Class 1 Medical Device with the FDA.

The U.K.-based medical tech company plans to launch the device in the U.S. later this year, according to a press release.

The idea behind the test is that pepsin — which has been shown to be very damaging to the esophageal and laryngeal tissue compared with acid alone — should only be found in the stomach, and therefore detection of it in the esophagus, throat, mouth or lungs indicates it has been refluxed.

“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,” Peter Dettmar, PhD, gastrointestinal specialist, director of RD Biomed and the creator of Peptest, said in the press release. “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 ... to be analyzed, so it’s pain-free, low-cost and easy to administer.”

Several clinical studies have demonstrated the test’s accuracy, Dettmar added. It has performed with 95% sensitivity, 89% specificity, and a detection limit of 16 ng/mL, which is the lowest measurable amount of pepsin, according to the press release.

“[We] believe it can help patients get a diagnosis of reflux much more quickly [so they can] get onto an appropriate treatment regime or a lifestyle regime faster,” he said.

Peptest is CE-marked in Europe and the company is in the process of registering the device in China, Taiwan, Brazil and Singapore, according to the press release.

Disclosures: Dettmar is the creator of Peptest and is the director of RD Biomed.

RD Biomed has registered Peptest, a noninvasive device that diagnoses GERD by using antibodies to detect the gastric enzyme pepsin in saliva, sputum or exhaled condensate samples, as a low-risk Class 1 Medical Device with the FDA.

The U.K.-based medical tech company plans to launch the device in the U.S. later this year, according to a press release.

The idea behind the test is that pepsin — which has been shown to be very damaging to the esophageal and laryngeal tissue compared with acid alone — should only be found in the stomach, and therefore detection of it in the esophagus, throat, mouth or lungs indicates it has been refluxed.

“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,” Peter Dettmar, PhD, gastrointestinal specialist, director of RD Biomed and the creator of Peptest, said in the press release. “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 ... to be analyzed, so it’s pain-free, low-cost and easy to administer.”

Several clinical studies have demonstrated the test’s accuracy, Dettmar added. It has performed with 95% sensitivity, 89% specificity, and a detection limit of 16 ng/mL, which is the lowest measurable amount of pepsin, according to the press release.

“[We] believe it can help patients get a diagnosis of reflux much more quickly [so they can] get onto an appropriate treatment regime or a lifestyle regime faster,” he said.

Peptest is CE-marked in Europe and the company is in the process of registering the device in China, Taiwan, Brazil and Singapore, according to the press release.

Disclosures: Dettmar is the creator of Peptest and is the director of RD Biomed.