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: APTIMA® HPV Assay
PMA Applicant: Gen-Probe Incorporated
Address: 10210 Genetic Center Drive, San Diego, CA 92121-4362
Approval Date: October 28, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100042a.pdf
What is it? The APTIMA® HPV Assay reagents are used with the TIGRIS® DTS ® System to identify human papillomavirus (HPV) RNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. All currently approved HPV assays detect HPV genomic DNA. This is the first FDA approved assay that detects the messenger RNA of two HPV viral oncogenes, E6 and E7. If test results are positive, the patient is likely to be infected with HPV.
How does it work? RNA is isolated from a scrape of cells from a woman’s cervix and is mixed in reaction tubes with reagents that specifically capture and amplify HPV RNA. This reaction is detected by another substance that produces light, which is then measured to determine the presence of HPV in the cervical sample.
When is it used? Test results may be used in women 30 and over, or women 21 and over with borderline cervical 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. Although HPV infection is very common, and usually self-resolving, if HPV RNA is present, the patient is in a higher risk category for developing cervical cancer than if HPV is not detected.
When should it not be used? This assay is not intended for use as a screening device for women under age 30 with normal cervical cytology.
The APTIMA HPV Assay is not intended to substitute for regular cervical cytology screening.
Detection of HPV using the APTMA HPV Assay does not differentiate HPV types and cannot evaluate persistence of any one type.
The use of this assay has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (e.g., HIV+, immunocompromised, history of sexually transmitted infection).
Additional information: Summary of Safety and Effectiveness and labeling are available online.