Integrated, on-chip RT-MME-PCR for influenza diagnostics; Phase 1 = sample prepar
DESCRIPTION (provided by applicant): Influenza viruses are highly contagious, segmented negative-sense RNA viruses that belong to the family Orthomyxoviridae, causing approximately 114,000 hospitalizations and 20,000 deaths annually. Several drugs are appr
oved by the US Food and Drug Administration (FDA) for treating influenza infections, but successful treatment depends on administering these drugs within the first 48 h of illness. The recent outbreak of avian influenza H5N1 in East Asia has further fueled
concern over another pandemic and emphasizes the need for comprehensive strain sub-typing in surveillance and diagnostic applications. The objective of this Application is therefore to develop an integrated, sample-to-answer PCR array for influenza diagno
stics in clinical specimens based on Akonni's gel element array technology. Specific aims in Phase 1 are to develop and implement an internal standard for on-cartridge influenza RNA sample preparation and detection; develop a sample preparation sub-circuit
for viral RNA isolation and purification; and assess influenza sample preparation efficiency and efficacy in amended clinical samples. Success in Phase 1 will result in a Phase 2 proposal where the specific aims will be to establish influenza reverse tran
scriptase, multiplexed, microarray-enhanced polymerase chain reaction (RT-MME-PCR) amplification protocols on the Akonni gel element array platform; integrate the sample preparation and RT-MME-PCR array functions into a plastic test cartridge; and test and
evaluate the integrated prototype on an extensive panel of influenza in neat and amended nasal swabs, throat swabs, nasal lavage and/or sputum clinical samples in preparation for 510K submission with Quidel Corporation. The performance goal at the end of
Phase 2 is a sample-to-answer result in 2 hours or less at an input target concentration of 103 TCID50 mL-1 nasal swab, throat swab, or nasal lavage. Successful demonstration of an integrated, multiplexed RT-MME-PCR chip in amended clinical samples will la
y the foundation for implementing Akonni's portable surveillance and diagnostic system for the rapid, trace detection and characterization of RNA viruses, upper respiratory pathogens and infections. Influenza viruses are highly contagious and cause
approximately 114,000 hospitalizations and 20,000 deaths annually in the U.S. alone. The continued emergence of new strains (such as influenza A H5N1) in East Asia highlights the need for rapid, comprehensive surveillance and diagnostic tools. Akonni's te
chnology and product solutions provide a straightforward path for diagnostic detection of trace RNA viruses and infectious diseases in an integrated, sample-to-answer test cartridge and field portable instrument.
Small Business Information at Submission:
AKONNI BIOSYSTEMS, INC.
400 Sagner Avenue Suite 300 Frederick, MD 21701
Number of Employees: