VRI happy with H. pylori diagnostic study

VRI BioMedical's OncoAlert diagnostic test has performed well in a clinical study examining the test's ability to diagnose Helicobacter pylori infections.

The test has been developed as a non-invasive tool to diagnose H. pylori infections and determine the risk of developing gastric cancer. More than half of the world's population is infected with H. pylori, which is the primary cause of gastric and duodenal ulcers, and the pathogen is also thought to be responsible for 70 per cent of gastric cancer cases.

"We've shown that we can diagnose H. pylori infections very satisfactorily," said Mark Rowbottam, general manager for diagnostics at VRI. He said that the recent clinical study demonstrated accuracy of about 90 per cent, which was comparable to or better than existing tests for the bacteria.

But VRI is hoping that its diagnostic tool is also accurate in predicting the risk of an H. pylori-infected individual developing gastric cancer. The company is presently conducting further studies with groups in Europe and Asia to see whether this is the case.

According to Peter French, VRI's chief operating officer, there is currently no early predictive test for asymptomatic patients which can lead to a delayed diagnosis and a poor prognosis. The current technique used to diagnose gastric cancer is endoscopy, which requires invasive surgery and is expensive.

OncoAlert, on the other hand, is a non-invasive blood test that looks at the antibodies generated in response to the H. pylori infection, particularly the levels of different antibody subtypes. Patients at higher risk of developing gastric cancer have decreased levels of specific antibody subtypes.

"It's well established that the antibody response in susceptible people weakens over time," said Rowbottam.

In the current study, which was carried out in association with Royal Mary Hospital in Hong Kong, samples from patients with gastric cancer will be tested to investigate the accuracy of predicting the risk of developing cancer. Rowbottam said that the company hoped to have completed sample collection by the end of March and expects to have results by the middle of the year.

If all goes well, the new test could be available by the end of this year, depending on regulatory requirements. Initially a lab-based assay is planned, but the company is working with Sydney company Proteome Systems on a point-of-care assay.

"We're looking at selling the diagnostic test to a global distributor, and have commenced talks with several companies regarding this," said French.