Unmet Medical Need: The advent of the polymerase chain reaction (PCR) has transformed medicine and biology by facilitating detection and quantitation of microbial gene products. However, PCR is not well suited to highly multiplexed microbiological analyses because primer interactions can reduce sensitivity and the repertoire of reporter systems typically limited to 10 to 20 targets. In contrast, DNA microarray technology offers possibilities for extensive multiplexing but sensitivities are generally too low to allow detection without amplification. With the advent of third-generation sequencing technology, it may be possible to directly sequence DNA for identification, but such approaches are still out of reach and may never be appropriate for point-of-care diagnostics.

Envisioned Healthcare Product: Drs. Shepard and Lipkin instead focus on a new assay platform that has the potential to deliver qPCR levels of sensitivity without amplification, while delivering the degree of multiplexing characteristic of DNA microarray technology. The transduction method is label-free, further simplifying sample preparation protocols. Transduction is based on nanoscale field-effect transistors (FETs), in the form of carbon nanotube devices, for single-molecule detection. The approach allows arbitrarily low levels-of-detection to be achieved, limited only by “incubation” times. Detailed kinetic information also allows discrimination of single or few nucleotide mismatches.

Stage of Development:  Start-up

Collaborative Research Team: Kenneth Shepard PhD and Ian Lipkin MD

Columbia-Coulter Funding Cycle: 2011-2012