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FDA gives premarket approval to two new tests to help physicians identify women with high-risk HPV.
The company says the Cervista HPV HR test more reliably detects than did previous technology the 14 high-risk types of HPV known to cause cervical cancer, and it is the first HPV DNA test approved by the FDA in a decade. It's approved for (1) screening patients with ASC-US cervical cytology results to determine if they should be referred to colposcopy and (2) adjunctive use with cervical cytology to screen women aged 30 and older to assess presence or absence of high-risk HPV type.
The second, Cervista HPV 16/18, is the first HPV test approved for genotyping of HPV types 16 and 18, the two most oncogenic and persistent HPV types, known to be linked with about 70% of all cervical cancers in this country. It is also approved for two uses: (1) in women aged 30 and older for adjunct use with the Cervista HPV HR test in combination with cervical cytology to assess for specific high-risk HPV types and (2) adjunct use with that same test in patients with ASC-US cervical cytology results to assess for specific high-risk HPV types. During a clinical trial involving 4,000 women nationwide, the Cervista HPV HR test achieved 100% sensitivity for detecting CIN3.
For more information, visit the company's Web site at http://www.hologic.com/.