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 ...
Read More »Genital swab claim cleared for HSV test, 11/15
November 2015—Quest Diagnostics announced that its Focus Diagnostics products business has received 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 and 2 Direct molecular test on the 3M Integrated Cycler.
Read More »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 ...
Read More »Molecular group A strep test cleared
May 1, 2015—Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, recently announced the FDA 510(k) clearance and CLIA ...
Read More »Focus inks deal with Evogen for PCR probes, 4/13:88
Evogen has entered into a nonexclusive license agreement with Focus Diagnostics granting worldwide rights to incorporate Evogen HyBeacons PCR probe technology into Focus Diagnostics’ molecular diagnostic products and services.
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