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Akonni, Wadsworth Center Developing PCR Arrays for Viral Encephalitis, Meningitis

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Akonni Biosystems and Albany, NY-based Wadsworth Center are working together under a $300,000 National Institutes of Health grant to develop a closed amplicon PCR microarray to detect encephalitis- and meningitis-causing viruses in cerebral spinal fluid, Akonni said this week.

Under the one-year award, administered by the National Institute of Allergy and Infectious Disease, the Laboratory of Viral Diseases at the Wadsworth Center will develop a set of real-time and reverse-transcriptase PCR assays to detect enterovirus, five herpes viruses, and West Nile virus.

Frederick, Md.-based Akonni will then combine the assays with its proprietary gel-drop microarray technology in a "self-contained microfluidic chamber," Kevin Banks, vice president of sales and marketing at Akonni, said in a statement.

According to the NIAID grant's abstract, the performance goal for phase one of the project is to develop a closed amplicon RT-PCR array for detecting the encephalitis- and meningitis-causing viruses with an analytical limit of detection of 50 genome copies per reaction. In addition, the assay will contain an exogenously spiked, quantified extraction and amplification control to be amplified and detected in the same multiplex reaction.

Successful completion of either of these goals in the first phase will warrant a phase two proposal focused on reagent stability, packaging, and shelf life; pre-clinical experiments to demonstrate assay reproducibility, repeatability, sensitivity and specificity; and development of automated algorithms and decision rules for assay data analysis and reporting, according to the grant's abstract.

Encephalitis and meningitis are characterized by acute inflammation of the brain or protective membranes covering the brain and spinal cord, and are often caused by viruses, bacteria, fungi, or parasites.

The potential for, and nature of, medical complications arising from CSF infection vary with the causative organism, as does the choice of appropriate treatment, Akonni said. As such, rapid and accurate identification of viral nucleic acid in the CSF of a patient with encephalitis or meningitis can help direct therapy and minimize morbidity and mortality, according to the company.

Akonni's TruArray technology platform comprises TruTip kits for ultra-rapid DNA and RNA extraction; the TruDx 2000 optical detection instrument; and TruDrop microarrays, low-density arrays of immobilized three-dimensional 100-by-20-micron drops containing all probes and chemistry necessary for a PCR reaction.

Akonni said that the underlying technology of the diagnostic array for viral encephalitis and meningitis will find broad application in many areas of infectious disease diagnostics.

"The development of rapid, low-cost, molecular diagnostic tests for use in near point-of-care settings has the potential to change the way CSF infections are identified," Banks said in a statement. "Combining RT-PCR with our proprietary gel-drop microarray platform in a self-contained microfluidic chamber will further enhance our ability to develop and deploy multi-test panels to affordably and rapidly detect viruses, bacteria, fungi, and parasites in a single patient sample."

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