Biota's Flu Diagnostic Test Filed in the United States
Melbourne, Australia, 11 May 1998
Biota Holdings Limited today announced the filing for clearance to market its rapid diagnostic test for influenza, AB FLU OIAr with the Food and Drug Administration (FDA) in the United States.
This follows the recent filing with regulatory authorities in Australia by Glaxo Wellcome Australia of Biota's anti-flu drug, RelenzaTM.
The diagnostic 510K was filed in the United States by Biota's partner in its development, BioStar, a diagnostic company based in Boulder, Colorado.
Subject to clearance from the FDA, Biota and BioStar plan to launch the diagnostic in the United States later this year. Marketing outside the United States will also begin later this year ahead of the northern hemisphere winter.
Biota and BioStar will share profits from sales of the diagnostic in the United States and Biota will pay BioStar a royalty on sales made outside the United States. Sales of the diagnostic are expected to be limited prior to the availability of Relenza on the market.
Biota's Chief Executive Officer, Dr. Hugh Niall, said: "Our goal was to develop a simple, rapid `point of care' diagnostic which detects both influenza A and B in 15 minutes."
"The AB FLU OIA test can be performed in the local doctor's office without the need for instrumentation. It can be used with multiple sample types and provides excellent performance," Dr. Niall said.
"We expect that it will become an effective tool in quickly identifying patients with influenza, who can then be treated with the influenza therapy, Relenza, when it becomes available."
BioStar's CEO/President, Teresa W. Ayers, said: "The development program with BioStar was initiated in April 1997 and is an excellent example of how drug development companies and diagnostic companies can work together to develop effective tools for disease management".
Clinical trials of the diagnostic were conducted at four locations in the United States during the last northern hemisphere winter.
More than 400 specimens, including nasal and throat swabs, nasal washes and sputum were collected from 183 patients who were clinically diagnosed as having influenza. These were analysed using the AB FLU OIA diagnostic and a reference method (14-day viral culture).
The results of this study, together with extensive laboratory data, met the goals set for the program and supported the submission to the FDA.
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 viral respiratory diseases and cancer. The Company's ADRs trade in the US on the pink sheets (BTAHY) at a ratio of three shares to each ADR. |
