In a collaborated effort with assay partner GenArraytion Inc., ExcitePCR successfully detected the Ebola virus on the Firefly Dx prototype system. The Ebola virus was tested at a low number of copies via polymerase chain reaction (PCR) and the amplification curves demonstrated a cycle threshold (Ct) of 21. The automated runs successfully synthesized cDNA using a proprietary reverse transcriptase (RT) step and then completed a 40-cycle PCR to produce the results.
Rapid detection and diagnosis of the Ebola virus infection along with vaccination is imperative to quickly containing an epidemic. Ebola is an RNA virus and requires a RT step prior to PCR. Despite its potential diagnostic advantages, RT-PCR methodology (both conventional and real-time approaches) typically requires significant laboratory infrastructure, electrical power, multiple temperature-sensitive reagents, the operation and maintenance of specialized equipment, and technical expertise in molecular biology, potentially complicating deployment in resource-limited settings.
"At the height of the Ebola virus outbreak, there were multiple challenges with accurately diagnosing individuals due to the need to collect samples, take them back to a central lab, and then wait hours or even days for results," stated Lyle L. Probst, CEO and President of ExcitePCR."Firefly Dx could eliminate those challenges as a self-contained, portable lab for point-of-care/point-of-need applications, providing results in 30 minutes."
The recent outbreak of the Ebola virus disease in West Africa has highlighted both the importance of rapid and accurate diagnosis of this disease and the challenges around diagnostic testing. Throughout the 2014-2015 outbreak, diagnosis relied primarily on the testing of venipuncture blood samples from symptomatic individuals in a biocontainment laboratory facility, leading to challenges with specimen collection and data management and often a prolonged turnaround time to final results.
Mr. Probst continued, "Ebola detection is a perfect example of an application where Firefly Dx could be particularly critical in remote locations, far from lab facilities, where time to results can mean life or death. This is why we have formed ExcitePCR; to facilitate getting the necessary strategic partner and direct funding in place to complete the development of what we believe is a very important product that can change the face of biological detection."
In addition to the Ebola virus, the Firefly Dx prototype system has also successfully detected a number of other pathogenic organisms, including Zika, E. coli, influenza, MRSA, MSSA, C. diff, and others.