Rockeby awaits US marketing approval

Singapore's Rockeby biomed (ASX:RBY) is a step closer to gaining US marketing approval for its candiadiasis diagnostics, Syscan3 and Candia5, having released results of its US 510(k) study which confirmed that both tests are effective as diagnostic aids when used in conjunction with microscopy and microbiological culture.

Rockeby managing director Dr Sze Wee Tan said the results replicated those of an earlier study, published in Asia, and that the data had been submitted to the US Food and Drug Administration.

The SysCan3 test -- used to diagnose systemic candidiasis in immunocompromised patients -- was negative in 89 per cent of cases confirmed as negative by microscopy and culture and positive in 73 per cent of symptomatic cases confirmed as positive by microscopy and culture.

"We were quite please with the result, which showed that the sensitivity for Syscan3 was 73 per cent and specificity was 89 per cent - not too far off the Singapore study," said Tan. "The Singapore [study] showed 78 per cent sensitivity and specificity of 90 per cent."

The point-of-care Candia5 test was negative in 82 per cent of cases confirmed as negative by microscopy and culture and positive in 70 per cent of symptomatic cases confirmed as positive by microscopy and culture.

"In the submission to the FDA we are promoting Candia5 to be used in conjunction with microscopy," said Tan. "Combining the tests will enable doctors to differentiate between vaginal colonisation and active infection - where the infection is severe enough for the patient to have antibodies."

Tan explained that doctors would then be able to determine whether patients required stronger treatment and monitor them for ongoing infection.

The tests are already approved in many Asian countries. "At the moment the key markets are Singapore and Australia, New Zealand," said Tan. "The pick-up of Candia5 in Australia in the last year has improved." He said the number of units sold between July and December 2004 was "much higher" than the sales for the whole of the preceding financial year.

Rockeby is also expecting European CE Mark approval by the end of March.

A saliva-based version of the CanDia5 test, suitable for over-the-counter sales, is poised to begin development. Tan expects Rockeby to begin production for clinical evaluation of the test in the second half of the year.