Aspergillus EIA test receives FDA 510(k) clearance

Sensitive, non-invasive test simplifies and speeds up diagnostic process and reduces chances of misdiagnosis

Bio-Rad Laboratories reports that on 16 May 2003 it received Food and Drug Administration (FDA) clearance to market its Platelia Aspergillus EIA test kit in the United States.

It is the first test available in the USA for Invasive Aspergillosis.

Hospital laboratories, reference laboratories and transplant centres may now use the test as an aid in the diagnosis of the infection.

The test has been used extensively in Europe and in a recent North American study, the test proved to be accurate in diagnosing the infection in bone marrow transplant and leukemia patients.

"We are very pleased to receive FDA clearance for this test, said John Goetz, Bio-Rad vice president and group manager of clinical diagnostics.

"We look forward to making it available for widespread use in the USA and hope that it will lead to faster, improved methods of treatment".

Invasive Aspergillosis is one of the most common opportunistic fungal infections and causes high mortality rates in immunocompromised patients like bone marrow transplant patients and patients with hematological malignancies.

More than 17,000 bone marrow transplants are conducted each year in the USA.

Mortality rates for Invasive Aspergillosis have been reported to be as high as 50-100 percent.

The infection is typically very difficult to diagnose and traditional methods of diagnosis such as histopathological examination of biopsies and/or radiological examinations not only require invasive surgical procedures, but can also produce results that are inconclusive, often leading to inappropriate treatment and death.

Bio-Rad's Aspergillus test is an accurate, non-invasive EBA-2 monoclonal antibody based microplate assay that utilizes blood samples for testing and can be used in conjunction with other diagnostic methods.

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