Visible Genetics is on track to become the first company to offer a low-cost, rapid, easy-to-use system for clinical diagnostic genotyping using DNA sequencing, starting with HIV drug resistance testing. The company anticipates FDA approval by the end of the year for its HIV GeneKit. Not only does it want to secure a first-mover advantage in HIV resistance testing, but by giving away its DNA sequencer, VGI intends to use this footprint to introduce HCV, HBV and, potentially, cancer diagnostics. And while its sequencing system is not as high throughput as those used in central reference labs, VGI expects to penetrate the market by establishing the capability for decentralized clinical diagnostic technology.ts management team in the past year. Its statements on FDA approval have been as aggressive as its corporate moves.
by Mark L. Ratner
With the introduction of protease inhibitors and other new drugs in the mid-'90s to combat HIV/AIDS, the economics of treating...
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