Thursday 8 December 2011
Cervista HPV HR is the first FDA-approved high-risk HPV test designed to detect all 14 oncogenic strains of HPV and reduce false-positive results associated with low-risk cross reactivity. Cervista HPV HR contains a unique internal control to validate that sufficient DNA is present for testing.
Genotyping for High-risk HPV Types 16 & 18
Cervista® HPV 16/18 is the first HPV genotyping test approved by the FDA, allowing you to individually identify and differentiate high-risk types 16 and 18.
Generally considered the two most highly oncogenic and persistent high-risk HPV types, 16 and 18 are associated with approximately 70% of cervical cancers. A prominent long-term study reported that types 16 and 18 are respectively 5.5 and 4.5 times more likely to cause CIN 3+ than all other high-risk HPV types combined.
The Cervista HPV 16/18 test provides important clinical information for tailored patient management.
Like the Cervista HPV HR test, Cervista HPV 16/18 is built on Invader® chemistry allowing for accurate detection of these two high-risk strains.
Both tests, Cervista HPV HR and Cervista HPV 16/18, can be run from the same 2 mL sample taken from the ThinPrep® Pap Test.
The increased risk associated with HPV types 16 and 18 is well documented. Many studies have also reported that women infected with HPV types 16 and 18 specifically, have a significantly higher risk for developing CIN3+ in comparison with women infected with all other high-risk types.
Khan et al. reported that 21% of cytology-negative, HPV 16-positive women developed CIN3+ over a 10-year period, while 18% who were cytology-negative and HPV 18-positive developed CIN3+ during this period. For all other high-risk HPV types combined, only 1.5% developed CIN3+, underscoring the value in genotyping specifically for HPV 16 & 18 in evaluating a patient’s risk for developing cervical cancer.
While the role of genotyping continues to evolve, guidelines have been issued to address cytology negative, HPV positive women 30 years of age and older.
This algorithm, issued by the American Society for Colposcopy and Cervical Pathology (ASCCP) states that "…in cytology negative women 30 years and older who are HPV DNA positive (for any of the 13 or 14 high-risk types of HPV detected by the high-risk HPV assays), molecular genotyping assays that detect HPV 16 and 18 would be clinically useful for determining which women should be referred for immediate colposcopy, and which could be followed-up with repeat cytology and high-risk HPV testing in 12 months2."