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U.S. Department of Health and Human Services

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APTIMA® HPV 16 18/45 Genotype Assay - P120007

APTIMA® HPV 16 18/45 Genotype AssayThis 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 16 18/45 Genotype Assay

PMA Applicant: Gen-Probe Incorporated

Address: 10210 Genetic Center Drive, San Diego, CA 92121-4362

Approval Date: October 12, 2012

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/p120007a.pdf

What is it? The APTIMA® HPV 16 18/45 Genotype Assay is used with the TIGRIS® DTS® System to identify human papillomavirus (HPV) RNA from high-risk genital HPV genotypes 16, 18 and/or 45. Similar approved devices do not include HPV genotype 45, although the risk profile and performance of this test with this new genotype included is similar to approved methods. If test results are positive, the patient is likely to be infected with one or more of the HPV genotypes 16, 18 and/or 45.

How does it work? RNA is isolated from a scrape of cells from a woman’s cervix and is then 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 age 30 and over, or women 21 and over with borderline cytology results, who test positive by the APTIMA HPV Assay, 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 a physician about a patient’s risk for developing cervical cancer. Although HPV infection is very common, and is usually self-resolving, if any of the HPV genotypes detected by this test are present, the patient is in a higher risk category for developing cervical cancer than if HPV 16, 18 and 45 are not present, or if only other high-risk genital HPV types are detected.

When should it not be used? This test is not intended for use in determining the need for treatment (ie. excisional or ablative treatment of the cervix) in the absence of high-grade cervical intraepithelial neoplasia (CIN). Patients who are HPV 16/18/45 positive should be monitored carefully for the development of high-grade CIN according to current practice guidelines.

The APTIMA HPV 16 18/45 Genotype Assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an APTIMA HPV Assay positive result, and should be interpreted in conjunction with cervical cytology test results.

The APTIMA HPV 16 18/45 Genotype Assay is not intended for use in women under age 30 with normal cervical cytology.

The APTIMA HPV 16 18/45 Genotype Assay is not intended to substitute for regular cervical cytology screening.

The use of this test 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: The Summary of Safety and Effectiveness Data and labeling are available.

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