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Medical Devices

cobas® HPV Test - P100020/S008

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 the device.

Product Name: cobas® HPV Test
Manufacturer:
Roche Molecular Systems, Inc.
Address:
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94588-0900
Approval Date:
April 24, 2014
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf10/P100020S008a.pdf

What is it? It is the first human papillomavirus (HPV) test for primary cervical cancer screening. The cobas HPV Test is used to identify 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 at the same time detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). If the test results are positive, the patient is likely infected with HPV.

The cobas HPV Test is automated and runs on the cobas 4800 system.

How does it work? DNA is isolated from a scrape of cells from a woman’s cervix and is 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 25 years and older as a first-line primary cervical cancer screening test to determine the need for additional follow-up and diagnostic procedures. Test results should be used together with the physician’s assessment of the patient’s screening 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 in determining the need for treatment of the cervix in the absence of high-grade cervical dysplasia. Patients who are HPV16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
  • women who have undergone hysterectomy.
  • use with samples other than those collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep® Pap TestTM PreservCyt® Solution.

The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, who are pregnant or who have other risk factors (e.g. HIV+, immunocompromised, history of Sexually Transmitted Infections).

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

Page Last Updated: 01/11/2016
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