• Assess risk of cervical cancer

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 one study involving more than 20,000 women, the 10-year cumulative incidence of ≥CIN3 was 17% and 14% of those infected at enrollment with HPV 16 or 18, respectively.¹ In comparison, the incidence was 3% for those positive for other HR HPV types. For those patients 30 years and older with negative cervical cytology, the cumulative incidences were 21%, 18%, and 2% when positive for type 16, 18, or other HR HPV types, respectively.¹ Based on these and other data, the American Society for Colposcopy and Cervical Pathology (ASCCP) recommends HPV 16 and 18 genotype testing for women 30 years and older who have negative cytology and a positive HR HPV test.^4,5

Although the ASCCP does not recommend HPV genotype testing for patients with atypical squamous cells of undetermined significance (ASC-US),^4,5 the FDA recently 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 and older who have negative cervical cytology and a positive HR HPV test

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

Submit 4 mL room-temperature ThinPrep^®′ cytology fluid; 2 mL minimum

Alternatively, submit 2 mL room-temperature SurePath^™′ cytology fluid after processing the Pap smear; 1 mL minimum

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

• Signal amplification using Invader^®′ technology

• CPT code*:  87621

The ASCCP guidelines^4,5 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

• If repeat cytology negative and HR HPV positive, refer for colposcopy

• If repeat cytology and HR HPV both negative, repeat screening in 3 years

• If repeat cytology positive and any HR HPV result, manage per guidelines (see reference 4)

Individuals who have ASC-US cervical cytology and HPV 16 and/or 18 have an increased risk of progression to ≥CIN2.^7,8 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.