Eyeballing HIV Drug Resistance Testing
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.
You may also be interested in...
The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.
Various government agencies are proposing greater government oversight of genetic testing, with the most controversial recommendation asking the FDA to regulate "home brews," the tests that clinical labs develop in-house for clinical purposes. As implementation plans are hashed out slowly, IVD kit makers and clinical labs see both opportunities and hurdles. Hospital labs are concerned about being overburdened by the new rules, while iVD makers worry that reform would give labs an unfair advantage.
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.