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Tag Archives: Focus Diagnostics—

DiaSorin enters molecular market with Focus buy

April 7, 2016—DiaSorin will buy Quest’s Focus Diagnostics immunodiagnostic and molecular diagnostic products business for $300 million in cash. The deal includes all the tangible and intangible assets of Focus used to develop, manufacture, and distribute its molecular diagnostic products and its traditional immunoassay ELISA products, including relevant intellectual property, contracts, and customer list. Focus’ products include the Simplexa molecular ...

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Genital swab claim cleared for HSV test

Sept. 3, 2015—Quest Diagnostics announced that its Focus Diagnostics products business has received FDA 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 and 2 Direct molecular test on the Integrated Cycler. The new labeling clearance follows the agency’s de novo 510(k) clearance and CLIA moderate-complexity categorization of the Simplexa HSV 1 and 2 Direct in ...

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