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- Mary Jane Gore
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FDA APPROVALS Dade Behring Holdings received clearance from the U.S. Food and Drug Administration (FDA) to make its D-dimer test available on its Stratus® CS instrument, for use in STAT and central laboratories and in acute care settings, such as emergency departments. An elevated D-dimer result reflects increased fibrin formation and lysis, indicating the presence of a clot, and has been reported in venous thromboembolic diseases. Contact Melissa Ziriakus at (847) 236-7038.
Digene Corporation announced that the FDA has approved its High-Risk (HR) HPV DNA test as a screening test in conjunction with the Pap test for HPV infection in women age 30 and older. Called DNAwithPap, the testing combination brings improved sensitivity to screening for the cause of the second leading cancer in women worldwide. Contact Dan Hewitt at (202) 530-4695.
Bayer's Diagnostics Division has received FDA premarket approval after an expedited review for its VERSANT® HCV viral load assay. This hepatitis C assay measures…
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