FDA Approves New HPV Test

Persistent infection with HPV is the principal cause of cervical cancer, with HPV implicated in more than 99% of cervical cancer cases worldwide.¹ The cobas HPV (human papillomavirus) Test, recently approved by the FDA, identifies women at highest risk for the development of cervical cancer. The test individually identifies the HPV genotypes 16 and 18, which are the highest-risk HPV genotypes responsible for more than 70% of cervical cancer cases, while simultaneously detecting the 12 other high-risk HPV genotypes.¹ To date, the cobas HPV test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing, identifying more at-risk women earlier than Pap cytology testing alone.

The test is indicated for women aged 30 years and older to assess the presence or absence of the high-risk HPV genotypes 16 and 18 and other high-risk HPV types.² It is also indicated for women aged 21 years and older with findings of atypical squamous cells of undetermined significance on cervical cytology testing to determine the need for referral to colposcopy. The test is not intended to prevent women from proceeding to colposcopy if other clinical factors warrant it, nor is it intended for use as a screening device for women younger than 30 years with normal cervical cytology, as a substitute for regular cervical cytology screening, or for use in determining the need for treatment of the cervix in the absence of high-grade cervical dysplasia.

Patients who are identified as being positive for the HPV genotype 16 or 18 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 in women with prior cervical treatment; those who have had a hysterectomy; women who are pregnant; or those with other risk factors, such as HIV infection, a history of a sexually transmitted infection, or immunocompromised status.

Cervical specimens that may be tested with the cobas HPV Test are the liquid-based collection media ThinPrep Pap Test PreservCyt Solution and the endocervical brush/spatula collection device.

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References:

1. FDA approves Roche’s HPV test for identifying women at highest risk for cervical cancer. Available at: http://www.roche.com/media/media_releases/med-cor-2011-04-20.htm. Accessed May 15, 2011.

2. US Food and Drug Administration. Medical devices: cobas HPV Test – P100020. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm254518.htm. Accessed May 15, 2011.