US-based healthcare company Pearl Diagnostics has received the US Food and Drug Administration (FDA) 510(k) clearance for its MycoMEIA Aspergillus Assay.
MycoMEIA is said to be the first urine-based assay to receive FDA clearance for aiding in the diagnosis of Invasive Aspergillosis (IA), a lung infection found in immunocompromised individuals.
Invasive Aspergillosis is a significant threat to people with compromised immune systems, particularly patients undergoing treatments for haematologic malignancies and transplants.
It is also increasingly identified in individuals with severe acute and chronic lung conditions.
Pearl Diagnostics developed the MycoMEIA Aspergillus Assay as a non-invasive, microplate-based enzyme-linked immunoassay (ELISA) for rapid and reliable early detection of IA.
The clinical validation studies in the US and Europe showing higher sensitivity and earlier disease detection compared to existing methods.
The urine-based MycoMEIA testing could enhance patient outcomes by reducing unnecessary antifungal medication use.
Pearl Diagnostics, a Johns Hopkins spin-off, specialises in developing innovative in-vitro diagnostic tests for non-invasive detection of life-threatening lung infections.
The proprietary Smart Antibody technology detects microbial extracellular vesicles in urine, facilitating early diagnosis of bacterial and fungal infections.
Pearl Diagnostics founder and inventor Kieren Marr said: “The milestone marks the culmination of decades of translational efforts and we are indebted to the individuals who provided urine samples to assist development. Hopefully we can take this forward towards improving patient outcomes.”
University Hospital Leuven physician and haematology professor Johan Maertens said: “The high negative predictive value of this assay should empower clinicians to withhold unnecessary antifungal therapies in severely ill patients.
“Meanwhile, its sensitivity approximating 90% provides an excellent, non-invasive, and timely tool to diagnose invasive aspergillosis, the most common mold infection, in at-risk patients suspected of having this fungal disease.”
