I wasn't expecting this for at least a fortnight, new platform tech. early July. Expect $1.70+ over next month. PANBIO LIMITED 2002-06-14 ASX-SIGNAL-G
HOMEX - Brisbane
+++++++++++++++++++++++++ International medical diagnostics company, PANBIO today announced that the United States Food and Drug Administration (FDA) had advised that the company's Glandular Fever panel had been cleared for commercial distribution in the USA under 510(k) regulations.
The panel, which consists of three diagnostic marker blood tests, targets Epstein-Barr virus (EBV) which causes Glandular Fever.
PANBIO Chief Executive Officer, Mr Mel Bridges said that entry into the US market would provide significant opportunities for the company given that EBV infects 90% of the human population by adulthood.
Glandular Fever is the common name for a condition called Infectious Mononucleosis. The disease is characterized by extreme fatigue, sore throat and swollen lymph nodes.
Rarely is it fatal, but the extreme fatigue may cause a delay of several months before returning to normal fitness. Young people aged between 10 and 25 years are most vulnerable to the infection. Transmission is via saliva, and although kissing is an obvious method of transmission, transmission is also spread by airborne droplets.
Diagnosis is by clinical symptoms and from a laboratory test of a blood sample. As there is no vaccination, there is no efficient treatment of the infection, other than to ease the symptoms.
"We are delighted by the FDA response, especially as this is PANBIO's first FDA application for an Australian manufactured product," Mr Bridges said.
"The approval demonstrates that PANBIO has in-house regulatory expertise which will allow it to lodge further FDA applications for existing products and new products currently under development.
"This approval also strengthens our push into the broader US diagnostics market," he said.
FDA approval provides the momentum for the company to develop an expanded range of tests for the EBV virus.
"PANBIO aims to develop EBV tests to address a wider cross section of medical diagnostic applications including doctor's office testing for Glandular Fever," Mr Bridges said.
"Future EBV test will enable more efficient diagnosis of the virus which has also been implicated in autoimmune diseases such as rheumatoid arthritis, SLE and multiple sclerosis and can cause complications with transplant patients."
PANBI0 is at the forefront of developing medical diagnostics for new emerging infectious diseases, which are estimated to kill more than 17 million people worldwide each year.
With direct subsidiaries in Australia and the US, PANBIO is currently implementing plans to expand its technology base and continue expansion into new markets.
PBO Price at posting:
0.0¢ Sentiment: None Disclosure: Not Held