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Major Research Project RP001

Collaborating Institution: Mesa Tech International, Inc., Los Alamos, NM

Principal Investigator: R. Bruce Cary, PhD

Title of the Project: Lateral Flow Microarrays: A Platform for Multiplexed Point-of-care Diagnostics

Expected Product: Development of a device capable of rapidly detecting nucleic acid sequences in clinical specimens.

Description: Nucleic acid-based assays for pathogen detection and identification offer sensitivity, specificity and resolution. Unfortunately, the manipulations for these assays have traditionally relied on nucleic acid isolation and amplification methods poorly suited for use outside of an appropriately equipped laboratory. Nonetheless, a significant need exists for more comprehensive, specific and facile diagnostics for use at the point-of-care. Nucleic acid-based assays for pathogen detection and identification offer sensitivity, specificity and resolution. Unfortunately, the manipulations for these assays have traditionally relied on nucleic acid isolation and amplification methods poorly suited for use outside of an appropriately equipped laboratory. Nonetheless, a significant need exists for more comprehensive, specific and facile diagnostics for use at the point-of-care. Mesa Tech International, Inc. (MTI) is commercializing technologies developed by its founders at Los Alamos National Laboratory (LANL) under an exclusive license agreement with LANL. The MTIDx (Multiple Target Identification Diagnostic) platform integrates instrumentation-independent means of conducting all requisite steps of a NA molecular assay. Specifically, nucleic acids are extracted and purified from crude biological samples using a novel passive buffer exchange-based sample preparation system that completely eliminates instrumentation and user interventions. Purified nucleic acids are rapidly amplified in low thermal mass chambers by an inexpensive microheater system and a robust amplification reaction scheme. A novel fluid control system integrates the sample preparation, amplification and detection modules under the regulation of the same microcontroller employed for microheater control. MTI’s instrument independent approach and affordable platform design will offer point-of-care testing in a simple, self-contained disposable product that does not require costly investments in instruments or a laboratory infrastructure. The prototype MTIDx device is capable of sample-to-result testing in under 40 minutes.