FDA approval sought for Rockeby CANDIA5® diagnostic kit by bfk20410


									FDA approval sought for Rockeby CANDIA5® diagnostic kit

Sydney, Australia. 27 September 2004. Rockeby biomed (ASX: RBY) today
announced it has lodged a submission for regulatory approval from the United States
Food and Drug Administration (FDA) for its diagnostic test CANDIA5®.

CANDIA5® is a non-invasive rapid test for the diagnosis of vaginal candidiasis (or
thrush) via a drop of a patient's blood, with the results available within 5 to 10
minutes. An estimated 75% of women will get vaginal candidiasis once throughout
their lifetime. It is the only diagnostic test of its kind in the world.

The submission follows the completion of a 5 centre, 200 patient clinical trial lead by
Dr Jack Sobel from the College of Medicine at Wayne State University to meet the
requirements of Section 510(k) of the Food, Drug and Cosmetic Act. The Pre-market
Notification or 510(k) allows the FDA to determine whether the device is equivalent to
one that has already been classified. It is a much faster process than FDA approval
for drugs and other pharmaceuticals and once approved the device is able to be sold
to the US market.

The trial compared the test results from CANDIA5 ® with other methods currently in
use to diagnose vulvovaginal candidiasis (thrush). Comparisons included
microbiological diagnosis through microscopic examination culture of a vaginal
sample and a test for the detection of Candida proteins in serum.

Rockeby CEO Dr Sze Wee Tan said “The CANDIA5 ® FDA submission is an
important milestone for the Company. We have already been in contact with various
pharmaceutical and medical device companies who have existing strong franchises
in the women’s health sector to market and distribute CANDIA5 ® in the US. As our
FDA submission advances, we will be progressing these discussions.”
The CANDIA5 Rapid Candida Test is a highly sensitive immunochromatographic
point-of-care test device intended for clinical detection of antibodies of the IgG class
in human whole blood or serum that react with purified cellular Candida antigens.
Individual whole blood or serum may be used to establish serological evidence of a
current or recent vulvovaginal Candida infection. The device will detect antibodies
against most medically important Candida species. When used in conjunction with
microscopy and/or culture, CANDIA5 has been shown clinically to be a useful aid in
the diagnosis of vulvovaginal candidiasis.

The CANDIA5® test kit is already available and generating sales in Australia, New
Zealand, Hong Kong, Singapore, Vietnam, and Malaysia.

Rockeby biomed is an ASX-listed (ASX: RBY) biotechnology company engaged
primarily in the research, development and marketing of products for the diagnosis
and treatment of fungal infections in humans. The company's main market is that
of in-vitro diagnostic testing which covers serology tests in hospitals as well as
point-of-care products for use by consumers or health professionals operating
outside hospitals.

For further information, please contact:

Media                             Company
Rebecca Christie, Buchan          Dr Sze Wee Tan, Managing Director
Tel: +61 2 9293 2836              Tel: +65 6735-2363
Mobile: 0417 382 391              Mobile: +65 9664-6783
Email: rchristie@bcg.com.au       Email: szewee.tan@rockeby.com

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