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
panbio limited