Visible Genetics Inc.
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In Vivo presents another installment of our quarterly reivew of dealmaking--in this case July 2002-September 2002. Our data come from Windhover's Strategic Transactions Database. We include medical device financings by deal type; diagnostic financings by industry segment; pharma and biotech alliances by therapeutic category and industry segment; pharma and biotech financings by market segment, and pharma and biotech M&A.
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.
Two of the biggest in vitro diagnostics companies are positioning themselves to go head-to-head with the market leader. Abbott Laboratories' diagnostic division is teaming up with Celera Diagnostics to identify, develop and market genomics tests. Meanwhile, Bayer's diagnostics division is buying a small DNA sequencing company, Visible Genetics, in an effort to expand its product and technology portfolio in the molecular field.
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.
In Vitro Diagnostics
- Molecular Diagnostics & Genetic Testing
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