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Ortho-Clinical Diagnostics HIV assay approval

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson unit receives supplemental PMA approval Oct. 13 for its Vitros Anti-HIV 1+2 Assay to run on its Vitros 5600 Integrated and Vitros 3600 Immunodiagnostic platforms. The test is the first HIV assay to be approved for an integrated platform in the U.S., according to the company. Vitros 5600 allows labs to run HIV and other routine assays on a single platform, which eliminates the need for batch testing, the firm noted. Vitros 5600 and Vitros 3600 launched late last year, and since then, the company has released 112 assays for use on the systems. Approval of the complete 114-assay Vitros menu is expected by 2010. During J&J's Oct. 13 third-quarter earnings call, the firm said the addition of the new Vitros platforms has doubled the applicable market for Ortho-Clinical Diagnostics products

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