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.
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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.
The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.