Rockeby Biomed commences US clinical trial of thrush diagnostic

Recently listed Perth and Singapore biotech company Rockeby Biomed (ASX: RBY) has commenced a US clinical trial of its laboratory-based SysCan3 and rapid point-of-care CanDia5 diagnostic tests for Candida infections, as a step toward gaining FDA approval of the products.

While the company has evaluated the tests in trials for market approval in Australia and Asia, the US trial is necessary for the company to apply to the FDA under the provisions of the 510(k) Pre-Market Notification requirements.

Rockeby's managing director Dr Sze-Wee Tan said compliance with the 510(k) requirements was likely to be straightforward, and the company expected to submit the report of the trial by July this year. This would mean a strong likelihood that FDA approval would be received by the end of this year, he said.

The 200-patient trial is being conducted at five centres in the US, including Wayne State University in Detroit, the Medical University of South Carolina in Charleston, Drexel University College of Medicine in Philadelphia, Providence's Women's and Infant's Hospital and Magee Women's Hospital in Pittsburgh.

Tan said that the five investigators, including lead investigator of the trial Dr David Soper from the Medical University of South Carolina, and the president elect of the Infectious Disease Society of Obstetrics and Gynaecology in the US, were key opinion leaders in the US.

The trial would include four patient groups, including symptomatic and asymptomatic patients with a prior history of Candida infections -- which causes vulvovaginal candidiasis or thrush -- and symptomatic and asymptomatic patients with no prior history of the infection.

The tests would be compared to current methods of diagnosis, including microbiological diagnosis through microscopic examination, culture of a vaginal sample and a test for detection of Candida proteins in the serum.

The disease affects up to 10 per cent of sexually active women each year, with many women suffering from recurrent infections over their lifetimes.

The point-of-care test CanDia5 is already on the market in Australia, New Zealand, Singapore and Malaysia, and the company expects to roll out the test in a number of SE Asian countries including Hong Kong, Vietnam, Thailand, and Taiwan in the next few months, and the Philippines and China in the second half of the year.

SysCan3, which is more commonly used to diagnose systemic candidiasis in immunocompromised patients, is currently only available in Australia and Singapore, and the company has put further rollout of the test on the backburner while it concentrates on the larger point-of-care market. The company plans to trial the test further in 2005 in preparation for an FDA pre-market approval (PMA) application.

And Rockeby is in the process of developing a saliva-based version of the CanDia5 test, suitable for OTC sales. Tan recently told Australian Biotechnology News that it would have a prototype of the test available in the third quarter of this year.

Tan said the company had shipped around 20,000 CanDia5 units in the last six months, with growth of around 30 per cent per half year. But he estimated that the growth would be closer to 30 per cent per quarter when other SE Asian countries came online.

"We're aiming to hit the break even point about 12-18 months from now," he said.