Technology | March 13, 2009

FDA Approves Two Hologic HPV Tests

March 13, 2009 – The FDA has approved Hologic's premarket approval (PMA) applications for both the Cervista HPV HR (high risk) and the Cervista HPV 16/18 tests.

Cervista HPV HR, designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years. Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70 percent of all cervical cancers in the U.S.

The Cervista HPV HR test has been approved for two uses:
- To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
- Used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Cervista HPV16/18 test has been approved for two uses:
- In women 30 years and older the test may be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.
- Used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology 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 HPV16/18 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 U.S. 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 percent 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 HPV16/18 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 percent of cervical cancer. Previous studies have shown HPV 16 and 18 are respectively 5.5 times and 4.5 times more likely to cause cancer than all other high-risk HPV types combined.

For more information: www.hologic.com

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