Rockeby receives approval for flu test
Rockeby Biomed has received the European approval, CE Mark, for its Human Antigen Detection Test for Influenza A.
The CE Mark notification means that Rockeby will be able to launch the product in both Europe and Australia.
Clinical studies in Australia have proved that the test is able to detect various H5N1 strains of human origin. H5N1 is the cause of avian influenza in over 30 countries in the world, with numerous human cases in Indonesia and Egypt.
The test can be used as a first line detection tool to determine if the patients have been infected with the deadly bird flu virus. Early detection can save lives as commercially available prescription drugs have to be administered within 72 hours after infection with the virus.
It enables doctors and health care professionals to assess within 10 minutes if a case of flu requires special attention and quarantine. The test can be run in any clinical setting as it is designed as a point-of-care (POC) diagnostic kit, on nasal, throat and nasopharyngeal specimens.
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