IDE approval from FDA for use in US national clinical trial in study of bone marrow transplant patients prone to fatal fungal infection
Bio-Rad Laboratories reports that the US Food and Drug Administration (FDA) has approved a National Institute of Health (NIH)-sponsored IDE (Investigational Device Exemption) for its Platelia Aspergillus EIA test kit for use in a National Heart, Lung and Blood Institute-sponsored study of bone marrow transplant recipients (April 2003).
This population is typically prone to invasive aspergillosis, a serious fungal infection causing high mortality rates in immunocompromised patients.
The FDA IDE approval will allow for use of the test for this important study.
Invasive aspergillosis is a respiratory fungal infection that is very difficult to diagnose.
Traditional methods of detection like histopathological examination, biopsy and, or radiological examinations not only require invasive surgical procedures, but can produce results that are inconclusive, often leading to inappropriate treatment and death.
The Bio-Rad Aspergillus test, however, is a monoclonal antibody based microplate assay, which is a test method used in a variety of clinical applications such as HIV, infectious disease and food pathogen testing.
"We are very excited to have the opportunity to study patients with Bio-Rad's Aspergillus test in this large multi-center clinical trial," said principal investigator John Wingard, Professor of Medicine and Director, Blood and Marrow Transplant Program, University of Florida Shands Cancer Center.
"Use of the Bio-Rad test kit will simplify this study and maximize the accuracy of researchers' results so they can focus on the most important task of finding effective drug treatments for this fatal infection," said John Goetz, vice president of Bio-Rad's clinical diagnostics group.
"We are hopeful that this research will lead to improved medical treatment and that our test kit will be made available for widespread use in the USA in the very near future".
