CervistaTM HPV HR and GenfindTM DNA Extraction Kit - P080014
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.
Product Name: CervistaTM HPV HR and GenfindTM DNA Extraction Kit
PMA Applicant:Third Wave Technologies
Address: Third Wave Technologies, Hologic, Inc. 502 South Rosa Road, Madison , WI 53719
Approval Date: March 12, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080014a.pdf
What is it? These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to be 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 probes that specifically recognize HPV DNA. 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 30 and over, or women of any age with borderline 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 clinicians 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 test provides information to clinicians 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.
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.