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U.S. Department of Health and Human Services

Medical Devices

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cobas HPV Test – P100020

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.

Picture of cobas HPV Test.Product Name: cobas HPV Test
PMA Applicant: Roche Molecular Systems, Inc.
Address:
4300 Hacienda Drive, PO Box 9002, Pleasanton, CA 94588-0900
Approval Date: April 19, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100020a.pdf

What is it? The cobas HPV Test is an automated test run on the cobas 4800 system which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). If test results are positive, the patient is likely infected with HPV.

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 primers and probes that specifically recognize and amplify HPV DNA. This reaction produces fluorescence, 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 age 21 and older with borderline cellular (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 physicians on a patient’s risk for developing cervical cancer. Although HPV infection is very common, and usually self-resolving, if HPV DNA 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? The cobas HPV Test is not intended:

  • for use as a screening device for women under age 30 with normal cervical cytology.
  • to substitute for regular cervical cytology screening.
  • for use in determining the need for treatment of the cervix in the absence of high-grade cervical dysplasia.

Patients who are HPV 16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines. The use of this test has not been evaluated for the management of women with prior treatment of the cervix, those who had a hysterectomy, or who are pregnant, or who have other risk factors (such as, HIV positive, immunocompromised, history of Sexually Transmitted Infection (STI)).

Additional information: Summary of Safety and Effectiveness and labeling are available online.

Other Resources: