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FDA Approves Two Hologic HPV Tests
Date:3/13/2009

ogy results, to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy.

It is also noted that for both the Cervista HPV HR test and the Cervista HPV 16/18 test, the test results, along with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Cervista HPV HR clinical trial was one of the largest and most demographically diverse conducted in the United States to date, involving 89 sites and enrolling approximately 4,000 women nationwide. The trial met or exceeded all target endpoints: most importantly, the Cervista HPV HR test achieved 100% sensitivity for the detection of CIN3, an immediate precursor to cervical cancer.

The Company believes Cervista HPV HR provides a number of benefits over current products. Cervista HPV HR includes an internal control intended to verify adequate cellularity for testing, thus reducing the potential for false negative results. In addition, because it requires a smaller specimen volume, this technology may minimize inconclusive, or indeterminate results, which may lead to fewer patients being called back for repeat testing. More importantly, Cervista HPV HR is designed to minimize false positive results due to a low-risk HPV strain being mistakenly recognized as a high-risk HPV strain, thereby potentially reducing unnecessary clinical management and patient anxiety.

The additional approval of Cervista HPV 16/18 marks the first FDA approved HPV genotyping test available in the United States. The HPV strains identified by this test represent the two most oncogenic and persistent types of HPV, together believed to cause approximately 70% of cervical cancer. Previous studies have shown HPV 16 and 18 are respectively 5.5 times and 4.5 times more likely to cau
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SOURCE Hologic, Inc.
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