What are the FDA approved indications for the Cervista® HPV 16/18 test?
• In women 30 years and older the Cervista®HPV 16/18 test can be used adjunctively with the Cervista® HPV HR test in combination with cervical cytology to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. • To be used adjunctively with the Cervista®HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
