Submitted by BenAtkinson on 17 November 2015
A recent news story has brought to light that ‘A new biomarker to detect an infection caused by a common mold has been approved by the FDA for enrolling patients into drug studies, according to a guidance released Nov. 13’
Biomarkers are a broad category of medical indications of which imply a specific biological state. These biological indications observed within patients can be measured accurately and reliably. As such, they can be used to distinguish between what appear to be similar diseases from the medical symptoms portrayed by the patient. The FDA has approved the use of the biomarker – Galactomannan for the detection of invasive aspergillosis. Galactomannan is present in the cell wall of the mold Aspergillus and is released during replication. The FDA has now released a ‘‘Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis.’’ This guidance provides a qualified context of use (COU) for Galactomannan detection in serum and/ or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials”
Incorporation of testing for this biomarker via a galactomannan enzyme immunoassay will hopefully help define its role as an effective indication of Aspergillus infection and benefit patients with the use of more targeted treatments against the disease.
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