Biota Announces US FDA Clearance to Market Rapid Test for Influenza
First Rapid, Point-Of-Care Influenza Diagnostic
Available in the U.S.
3 December 1998
Melbourne, Australia - Biota Holdings Limited today announced that its collaborator, BioStar, Inc., has received clearance from the U.S. Food and Drug Administration to market their FLU OIA® rapid point of care influenza diagnostic. The Company expects that the product will be launched on Monday 7 December in the US, in time for the Northern Hemisphere flu season.
"FLU OIA® enables practitioners to perform proper and efficient diagnosis of influenza that is necessary for effective treatment and containment of the infectious disease", commented Dr. Hugh Niall, CEO of Biota Holdings Limited.
Developed using BioStar's Optical ImmunoAssay (OIA®) technology, the test can be performed in 15 minutes using any of several specimen types, including nasal aspirate, nasopharyngeal swab, throat swab or sputum. It can be performed in the local doctor's office. Clinical studies have shown that sensitivities of the FLU OIA® test approach or surpass those of conventional methodologies such as routine culture which can take several days to provide results.
FLU OIA® is the first commercially available product for Biota, a biotechnology company based in Melbourne, Australia. BioStar will market and distribute the diagnostic test in the U.S., Europe and New Zealand. PanBio Pty Ltd, an Australian based company, will market and distribute the product in Australia. BioStar retains worldwide manufacturing rights.
"A rapid test for early detection of influenza A and B in a point-of-care setting benefits doctor, patient, and the community at large: the doctor is better able to prescribe an appropriate therapy, the patient who is feeling sick has a shorter waiting time for diagnosis and the community has better influenza surveillance information to prevent its spread," stated Dr. Rita M. Gander of Southwestern Medical Center, University of Texas.
Patients at high risk for developing influenza-related complications include the elderly and persons with underlying health problems.
Influenza A & B infections occur every year in 10-15% of the population, though attack rates might be higher in closed settings such as old people's homes. In the US, where influenza and its complications are the sixth leading cause of death, the Center for Disease Control and Prevention reports that in an average year influenza is associated with about 20,000 deaths nation-wide and many more hospitalisations.
"We are extremely pleased to be able to offer this breakthrough diagnostic to physicians and their patients in time for the Northern Hemisphere flu season," said Teresa W. Ayers, BioStar's President and Chief Executive Officer. "Other diagnostic tests for influenza detect only influenza A or take much longer to produce results. This OIA® test is another example of BioStar developing and introducing innovative products, thus solidifying our position as a leader in rapid, point-of-care testing."
BioStar, Inc is a subsidiary of Thermo BioAnalysis Corporation (ASE-TBA).
Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development program focusing principally on the discovery of new human pharmaceuticals for the treatment of cancer and viral respiratory disease. The company's ADRs (BTAHY) trade in the US on the pink sheets at a ratio of three shares to each ADR.
For further information please contact:
Dr. Hugh NiallElizabeth Field / Michael MooreChief Executive OfficerTurnbull Porter NovelliBiota Holdings LimitedTelephone: 61 3 9289 9555Telephone: 61 3 9529 |
