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Abbott

BioMérieux’s NucliSens EasyQ MRSA test; Abbott's RealTime CMV assay; Roche's Cobas TaqScreen MPX Test v2.0; Idaho Tech's Q Fever molecular assay; Gen-Probe's Panther system.

Shortly after Pfizer's regulatory filings for the NSCLC ALK-inhibitor crizotinib in these two countries, Abbott submitted its premarket approval application with US and Japanese regulatory authorities for a FISH-based companion diagnostic test.

The test is being used in clinical trials with Pfizer's crizotinib, an anaplastic lymphoma kinase inhibitor.

Abbott's RealTime HCV assay.

According to Abbott, it is the only test for which the limit of detection and limit of quantitation are the same, 12 IU/mL.

Pfizer completed submission of its NDA for the ALK-inhibiting non-small cell lung cancer drug crizotinib, and was granted a priority review from the FDA. Meantime, Abbott Molecular plans to submit "shortly" a premarket approval application for a commercial companion diagnostic that will pick out best responders to crizotinib.

The method relies on metaphase CGH slides sold by Abbott Molecular. Its developers claim it is faster than traditional techniques like FISH, but cheaper than array-CGH.

Biofortuna will design, develop, and manufacture a range of freeze-dried HLA-typing kits with the brand name SSPGo for Abbott's molecular diagnostics business.

The company expects to launch more than a dozen new molecular diagnostic products over the next two to three years.

Upon regulatory approvals, Abbott will have exclusive distribution rights in the US and all other geographies, excluding France, Spain, Portugal, and the Benelux countries.

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