Rapid Molecular Assays for Fungal Infections

Sensitivity of real-time NASBA assay for fungi. B: pan-Candida probe, C: pan-Aspergillus probe

Invention Summary:

Fungal infections are as significant cause of mortality and morbidity when not rapidly diagnosed and treated. However, the current standard of care for diagnosis is blood culture, a method limited by the time to diagnosis (1-2 days), frequency of false negatives, and the difficulty in culturing certain fungi. The emergence of drug-resistant fungi adds an additional obstacle to effective treatment.

While molecular assays have enabled rapid, sensitive diagnosis of bacterial and viral infections, a lack of standardized, commercially available assays has limited their application to fungal infections. Rutgers researchers have developed PCR primers for detection of specific fungal species and detection of mutations associated with echinocandin-resistant fungi, enabling diagnosis within one hour.

By allowing immediate administration of the most effective anti-fungal drugs, these assays would greatly improve outcomes for fungal infections

Market Applications:

• Detection of species-specific fungal infection
• Pneumocystis
• Candida
• Aspergillus
• Identification of echinocandin resistant fungi

Advantages:

• Rapid time to diagnosis (1-3 hr)
• Detection of fungi that cannot be cultured
• Targeted treatment
• Detection of fungal species
• Detection of echinocandin-resistance
• Individual and multiplexed detection
• Analytical sensitivity: 0.1-0.2 CFU/rxn
• 100% analytical specificity for Aspergillus and Candida detection, echinocandin resistance
• Detection from biological and nonbiological samples

Intellectual Property & Development Status:

Issued and pending patents. Available for licensing and/or research collaboration.

Select Publications:

• Kordalewksa M et al, 2017, Rapid and accurate molecular identification of the emerging multidrug resistant pathogen Candida auris, J Clin Microbiol, 55:2445-2542
• Zhao Y et al, 2016, Blood Aspergillus RNA is a promising alternative biomarker for invasive aspergillosis, Med Mycol, 54:801-807
• Zhao Y et al, 2016, Rapid detection of FKS-associated echinocandin resistance in Candida glabrata, Antimicrob Agents Chemother, 60:6573-6577