This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Cervista™ HPV 16/18
PMA Applicant: Third Wave Technologies
Address: Third Wave Technologies, Hologic, Inc. 502 South Rosa Road, Madison , WI 53719
Approval Date: March 12, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080015a.pdf
What is it? These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16 and 18.
How does it work? DNA is isolated from a scrape of cells from a woman’s cervix and is subsequently mixed in reaction wells with probes that specifically recognize HPV type 16 and 18 DNA. This reaction is detected by another substance that produces light, which is then measured to determine the presence of HPV type 16 and/or 18 in the cervical sample.
When is it used? Test results may be used alongside, or as a follow-up to, the Cervista HPV HR test in women 30 and over, or women of any age with borderline cytology results, to determine the need for additional follow-up and diagnostic procedures. Test results should be used together with the physician’s assessment of cytology history, other risk factors, and professional guidelines.
What will it accomplish? The test provides information to clinicians on a patient’s risk for developing cervical cancer. HPV 16 and 18 are the two HPV types that are most commonly associated with cervical cancer in the United States. Although HPV 16 and/or 18 infection is very common, and usually self-resolving, if HPV 16 and/or 18 DNA is present, the patient is in a higher risk category for developing cervical cancer than if HPV 16 and/or 18 are not detected, or if other high-risk genital HPV types are detected.
When should it not be used? The Cervista HPV 16/18 test should not be used as a stand-alone assay. Cervista HPV 16/18 test results should be interpreted alongside, or as a follow-up to a Cervista HPV HR test result, adjunctively with cytology.
The Cervista HPV 16/18 test is not intended for use as a screening device for Pap normal women under age 30 and is not intended to substitute for regular Pap screening.
The use of this test has not been evaluated for the management of women with prior cytologic or histologic abnormalities, hysterectomy, who are postmenopausal, or who have other risk factors (e.g., HIV+, immunocompromised, DES exposure, history of STI).
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.