Rockeby says test can also apply to children
Tuesday, 19 October, 2004
Rockeby's (ASX:RBY) laboratory-based SysCan tests for Candida antibody levels is likely to be useful for diagnosing the infection in children, a trial in Singapore has found.
Rockeby managing director Dr Sze Wee Tan said the objective of the 100-patient trial -- which began in September 2003 and ended in March -- was to understand if the levels of antibodies which indicate infection in children were different from those of adults. "Syscan measures the levels of antibodies in the blood that correlate to infection," he said. "The study established that the cut-off would have to be lower in children than in adults."
Syscan was developed to test for the fungal infection in adults, but candidiasis in immunocompromised children such as those on chemotherapy is becoming increasingly common, and can be fatal.
"Invasive candidiasis is a serious infection in children with cancers," said Dr Zainal Muttakin, a paediatric registrar at Singapore's KK Women's and Children's Hospital, where the trial was conducted. "At present, the diagnosis based on traditional culture methods remains less than optimal. Only between 40 and 60 per cent of invasive candidiasis are picked up and usually at later stages of the disease."
Tan said the data from the Singapore trial would add insight to a trial Rockeby is conducting with Duke University. The US National Institute of Child Health and Human Development (NICHD) is sponsoring the study, which is aimed at evaluating Syscan's use for the diagnosis of candida infections in tiny premature infants.
"At this point in time [the Singapore study] will be considered pilot data," he said. "It is still considered preliminary and will support the full set of data that we may use for obtaining approval in the US for invasisve candidiasis diagnosis in children."
According to the company, a larger population-based study needs to be done to establish the normal baseline levels of the anti-candidal antibody in children
Syscan is a multi-well ELISA kit that can be used in a standard serology laboratory.
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