Influenza Detection System Combines Microarray System with PCR

The award will enable Akonni to combine the polymerase chain reaction (PCR) with its TruArray gel-drop microarray in a single chamber, closed-amplicon system, and field test it for the detection of Influenza A and B and their antigenic subtypes, including antiviral resistant types.

A molecular diagnostics (MDx) company, focused on providing rapid and highly scalable solutions for infectious disease testing, Akonni received the grant based on successful completion of an earlier Phase I SBIR.

The new PCR array technology is expected to deliver more cost-effective infectious agent panel testing by providing a level of multiplexing and genetic information only available with microarray technologies. Starting from PCR-ready material extracted from swabs or nasopharyngeal aspirates using Akonni TruTip extraction kits, the test will deliver sub-typing results in less than two hours with limits of detection equivalent to those of real-time PCR systems.

"The recent H1N1 influenza pandemic, and fears of future H5N1 influenza pandemics, is driving development of more rapid and comprehensive sub-typing technologies for surveillance and diagnostic applications”, explained Dr. George Rudy, chief medical officer of Akonni Biosystems. He added, "Four drugs have recently been approved by the US Food and Drug Administration (FDA) for the treatment of influenza, but the success of treatment depends on their early administration and may be related to the infecting strain.”

Wadsworth Center (Albany, NY, USA), Columbia University (New York, NY, USA), and Little Company of Mary Hospital (Evergreen Park, IL, USA), and the U.S. Centers for Disease Control and Protection (CDC; Atlanta, GA) are partnering with Akonni Biosystems on the program. Initially, Wadsworth Center is developing a focused panel of drug-resistance markers for the PCR array platform, providing clinical feedback to guide product development, and participating in preclinical verification of the technology on clinical specimens.

Akonni Biosystems aims to produce commercial products for clinical and research laboratories. Products in the company's near-term pipeline include multiplex panel assays for detecting the pathogens associated with multidrug-resistant tuberculosis, upper respiratory tract infections, viral encephalitis, and hospital-acquired infections.

Related Links:
Akonni Biosystems
National Institutes of Health
Wadsworth Center
Little Company of Mary Hospital
U.S. Centers for Disease Control and Protection