• Assess risk of cervical cancer in women ≥30 years of age who have a negative Pap test and a positive high-risk HPV test

• Assess risk of cervical cancer in women who have an ASC-US cervical cytology result and a positive high-risk HPV test

HPV infection causes the vast majority of all cervical cancers.¹ Genital HPV types are categorized as low or high risk based on their oncogenic potential.² Low-risk HPV types are typically associated with genital warts, whereas high-risk (HR) types are associated with invasive cervical cancer. Of the HR (oncogenic) HPV types, HPV 16 causes more than 50% of cervical cancers and HPV 18 causes 10% to 20%.³

The risk of developing cervical precancer (ie, grade 3 cervical intraepithelial neoplasia [CIN3]) or cancer is increased in women when they are infected with HPV 16 and/or 18. In a study involving more than 20,000 women whose HPV status was assessed at enrollment, the 10-year cumulative incidence of ≥CIN3 was 17% in those infected with HPV 16 and 14% in those infected with HPV 18.¹ In comparison, the incidence was 3% among those positive for other HR HPV types. For patients ≥30 years old with negative cervical cytology, the cumulative incidences were 21% among those positive for type 16, 18% for type 18, and 2% for other HR HPV types.¹ Based on these and other data, consensus guidelines recommend HPV 16 and 18 genotype testing for women ≥30 years old who have negative cytology and a positive HR HPV test (HR HPV testing is not recommended for women <30 with a negative Pap result).^4,5

Although the consensus guidelines do not recommend HPV genotype testing for patients with atypical squamous cells of undetermined significance (ASC-US),^4,5 the FDA has approved an HPV 16/18 genotyping test as an adjunct to guide management of these patients.⁶ Such management includes physician assessment of cervical cytology, HR HPV test results, and other risk factors.⁶

• Women ≥30 years old who have negative cervical cytology and a positive HR HPV test

• Women who have ASC-US cervical cytology and a positive HR HPV test

• DNA hybridization and capture using probes specific for HPV types 16 and 18

• Signal amplification using Invader^® technology

The consensus guidelines⁴ suggest the following actions for women 30 years and older with negative cervical cytology, positive HR HPV, and the genotype specified:

• HPV 16 and/or 18: refer for colposcopy

• No HPV 16 or 18: repeat both cytology and HR HPV testing in 12 months

Individuals who have ASC-US cervical cytology and HPV 16 and/or 18 have an increased risk of progression to ≥CIN2.^6,7 The results of this test should not preclude women from proceeding to colposcopy.

HPV 16 and 18 genotype test results must be interpreted in conjunction with results from HR HPV testing and cervical cytology.