a maddie, page-5

Rockeby OTC approval in Europe for rapid candida test
09:14, Monday, 2 April 2007

Sydney - Monday - April 2: (RWE Australian Business News) -
Singapore-based diagnostics group Rockeby Biomed Ltd (ASX code: RBY) has
received European Over-The-Counter (OTC) approval - 'CE OTC Mark' - for
its flagship product, CanDia5, for home or self-testing in Europe.
The CanDia5 Rapid Candida Test is used for the accurate
detection of Vulvovaginal Candidiasis (VVC) within six minutes.
VVC, which is also known as Vaginal Thrush, Monilial or yeast
infection, is a common cause of vaginal irritation.
The condition affects up to 75 per cent of all women during
their reproductive years (age 15 to 45).
Between 5% and 10% of healthy women of reproductive age may
suffer from recurrent VVC, which is defined as four to five infections
per year.
Symptoms of VVC are non-specific and neither self-diagnosis, nor
diagnosis by a physician, is reliable without laboratory confirmation.
Incorrect diagnosis can result in the overuse of topical
antifungal agents, with the subsequent risk of contact and irritant
vulvar dermatitis.
Obtaining the 'CE OTC Mark' for CanDia5 means that it can be
sold to consumers directly over the counter in any setting such as
pharmacies, and supermarkets in Europe, allowing Rockeby to promote and
market the product to a potential market of 15 million female users in
Europe for home or self-testing of VVC.