Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          FDA approves first HPV test for use with SurePath Preservative FluidPress Announcements FDA News Release
  FDA approves first HPV test for use with SurePath Preservative Fluid

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  July 07, 2016
 

 

  Español

The U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.

The FDA approves HPV tests to be used with specific collection fluid, which store and preserve cervical cell samples for testing in the laboratory. Until today, the FDA had not approved any HPV tests to be used with SurePath Preservative Fluid, one of two approved liquid collection fluids commonly used for Pap tests.

“Health care providers have been using samples stored in the SurePath Preservative Fluid with HPV tests for some time now, but there have been concerns about false negative results,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Now health care providers have access to an FDA-approved test and the information they need to use it properly to ensure the most accurate results for their patients.”

Prior to today’s approval, some laboratories used cervical cell samples collected in SurePath Preservative Fluid to run HPV tests, in lieu of collecting an additional sample in a separate collection fluid that had been approved for use with those tests. In 2012, the manufacturer of SurePath warned laboratories that using cervical cell samples in SurePath Preservative Fluid with a specific HPV test may lead to false negative results. Patients who receive false negative HPV test results may not receive appropriate follow-up care, which could lead to cervical cancer progression. The Roche cobas HPV Test now provides specific instructions for laboratories to process cervical samples collected in SurePath Preservative Fluid to minimize the risk of false negative results.

HPV infections are the most common sexually-transmitted infections in the United States, and HPV genotypes 16 and 18 cause approximately 70 percent of cervical cancers worldwide. According to the National Cancer Institute, there will be an estimated 12,990 new cases and 4,120 deaths from cervical cancer in the United States during 2016.

The Roche cobas HPV Test with SurePath Preservative Fluid is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV in order to determine whether additional follow-up and diagnostic procedures are needed. The FDA also approved the Roche cobas HPV Test with SurePath in women age 21 and older who have already had an abnormal Pap test result (borderline cellular cytology) in order to determine whether additional follow-up and diagnostic procedures are needed. The test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women.

The Roche cobas HPV Test with SurePath is not approved as a first-line primary HPV screening test. In addition, health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors.

The FDA based its approval of the Roche cobas HPV Test with SurePath Preservative Fluid on a clinical study of 952 eligible women 21 years and older with abnormal Pap test results. The Roche cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared to a previously approved cervical sample type. Of the samples that tested positive for HPV using the Roche cobas HPV Test with SurePath, 95.4 percent obtained the same result as the reference sample. Of the samples that tested negative for HPV using the Roche cobas HPV Test with SurePath, 93.2 percent obtained the same result as the reference sample.

The Roche cobas HPV Test is manufactured by Roche Molecular Systems, Inc., a part of the Roche Group, headquartered in Basel, Switzerland. SurePath Preservative Fluid is manufactured by Becton Dickinson and Company, located in Franklin Lakes, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nations’ food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###
Inquiries
  
    
        
         Media:
                 
      
                            Lyndsay Meyer
           
           
                      240-402-5345
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      07/08/2016
               
               
   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop