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Credible Competition for Roche In Molecular Diagnostics

Executive Summary

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.

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The Murky Regulatory Arena of Genetic Testing

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.

The Best of Three Worlds

Celera Diagnostics, a 50/50 JV between Applera Corp.'s two divisions, Applied Biosystems and Celera Genomics, is using the discovery, assay development, and systems expertise of its founders to help it commercialize reagent and software-based standardized molecular diagnostic tests. But Applera didn't step up to the plate until after it obtained an expanded license to PCR from Roche, giving it freedom to operate in the diagnostics arena, and convinced Kathy Ordoñez, president of Roche Molecular Systems, to join Applera and head the diagnostics program. Celera Diagnostics believes it will distinguish itself from other genomics-based companies pursuing diagnostics -- as well as from the traditional diagnostics players - by being able to efficiently discover new diagnostic markers by performing association studies to confirm the link between SNP sets and disease. Celera Diagnostics could also serve as an "earliest access" customer that contributes to and drives a new molecular diagnostics platform strategy for Applied Bio.

Vysis's Ship Comes In

Not too long ago, Vysis was just one of dozens of struggling genomic start-ups. Now, however, with its pending acquisition by Abbott Laboratories, it is a poster child for genomics success. Abbott is betting on the potential of Vysis's core position in fluorescent in situ hybridization (FISH) as a diagnostic tool, which allows users to evaluate disease based on changes at the chromosomal level. Abbott has been marketing Vysis's FISH test for the HER2 gene and since this summer.

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