FDA-Approved HPV Tests

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FDA-Approved HPV Tests

In 2003, Diagene introduced the Hybrid Capture 2 High Risk HPV DNA test. It was the first HPV test approved by the FDA for the detection of high-risk HPV (HR-HPV). Other HPV tests have also received FDA approval since then. The table below contrasts the FDA-approved HPV tests. The Hybrid Capture 2 DNA and the Cervista HPV DNA tests are further explained on the following pages.

Instrument (Manufacturer)
Summary of the Test
Test Principle
Intended Use
Hybrid Capture 2 High Risk HPV DNA test (Digene)
Identifies genetic DNA from HPV in cervical cells
Uses a DNA-Probe-Hybrid immunoassay technique and is used combined when a woman's Pap test results are mildly abnormal
  • Detection of high-risk HPV (HR-HPV)
  • Follow up test when a PAP smear is mildly abnormal
Cervista™ HPV HR and Genfind™ DNA Extraction (Hologic)
 Identifies DNA from 14 high-risk genital HPV types commonly associated with cervical cancer
Uses DNA-probe technology
  • Determine a patient's risk for developing cervical cancer
Cervista™ HPV 16/18 (Hologic)
 Identifies HPV types 16 and 18 in cervical samples
Uses specific DNA-probe technology and may be used in combination or as a follow-up to the Cervista HPV HR test
  • Determine a patient's risk for developing cervical cancer
  • Used for women age 30 and over or any age with borderline cytology results to determine the need for additional follow up procedures
cobas® HPV test (Roche Molecular Systems)
Used on the cobas® 4800 system to identify DNA from 14 high-risk genital HPV types commonly associated with cervical cancers. Specific for HPV types 16 and 18 but also identifies other high-risk types.
Uses fluorescent labeled DNA probes
  • Provides information on a patient’s risk for developing cervical cancer
  • For women age 30 or over or women age 21 and older with borderline cellular results to assess the need for additional follow-up and diagnostic procedures
APTIMA® HPV Assay (Gen-Probe) Used with the Tigris DTS system to identify RNA from 14 high-risk genital HPV types commonly associated with cervical cancer. Detects messenger RNA from two HPV viral oncogenes, E6 and E7
Uses RNA capture and amplification of HPV RNA
  • Determine a patient's risk for developing cervical cancer
  • Used for women age 30 and over or any age with borderline cytology results to determine the need for additional follow up procedures