FDA approval of HPV DNA test

Descriptions of New FDA-approved HPV DNA Tests In March 2009 the FDA announced approval for clinical use in the U.S. of two new HPV DNA diagnostic tests.1 One of these tests is designed to identify 14 high risk types of HPV. These include the 13 types detected by the Hybrid Capture® 2 HPV DNA Assay (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) as well as HPV 66. This test will be marketed under the name Cervista™ HPV HR. The other test is designed to specifically detect HPV 16 and HPV 18 and will be marketed under the name Cervista™ HPV 16/18. Both tests utilize an isothermal enzymatic DNA amplification process with a fluorescent read out and both are approved for use with ThinPrep® samples. They were developed by Third Wave Technologies which was acquired in 2008 by Hologic Inc., the manufacturer of the ThinPrep® Pap test.

אישור ה- FDA האמריקאי לבדיקת DNA לנוכחות HPV
 

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