PBO panbio limited

Glandular Fever Test Receives FDA Clearance

  1. 117 Posts.
    I wasn't expecting this for at least a fortnight, new platform tech. early July. Expect $1.70+ over next month.

    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.

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