CHICAGO, March 11 - A local genomics start-up is trying to develop a non-PCR-based handheld diagnostic device to help researchers use genomic data to identify a variety of organisms, infectious agents, and cancers in a physician's office.
Nanosphere, of Northbrook, Ill., currently has a tabletop device set to be reviewed by the US Food and Drug Administration in 2004. The handheld, now in the first stages of design, would be able to piggyback on that approval process because it shares basic technology with the bigger version and might be ready for market soonafter its sister device is approved, the company said.
In a paper published in the Feb. 22 Science, researchers at Northwestern University write that the technology relies on gold microparticles coated with amino-acid sequences that locate and bind to one end of a target gene sequence.
Sequences that match the other end are bound to a chip between two nanoelectrodes, the researchers write. When the targets are captured both by the gold particles and the chip, they anchor the particles to the chip. And when enough particles accumulate to bridge the electrodes, they send an electrical signal to the detector.
The head of the research team, Chad Mirkin, is a co-founder of Nanosphere, which has licensed the technology for commercial development. Nanosphere is backed by private investors and by Northwestern University, which has an undisclosed stake in the company.
Nanosphere chief operating officer Vijaya Vasista says pricing for the handheld won't be set for a while. However, she said the device itself might cost several thousand dollars while disposable cartridges for specific tests would have various prices depending on complexity or market demand.
But the technology may face an uphill start in the diagnostics community, especially when put up against the powerhouse private labs like Quest and Impath.
According to William Bonello, who covers the clinical laboratory industry for US Bancorp Piper Jaffray, the technology would have to be less expensive than tabletop versions, and not simply have a better cost-benefit ratio, if it hopes to displace centralized labs among health-care providers.
Plus, "insurers wouldn't reimburse for it separately, so there would have to be an economic incentive to do it on site," he said.
Vasista says competitors include Cepheid, Nanogen, and Clinical Microsensors, a Motorola subsidiary. Nanosphere estimates the annual US genomics-based research and diagnostic market to be around $2.8 billion.