Is there an FDA-approved Human Papillomavirus (HPV) test for men?

No FDA-Approved HPV Test for Men

There is no FDA-approved test for HPV in men. According to multiple CDC guidelines, no clinically validated test exists for men to determine if they have HPV infection 1, 2.

Current Testing Status and Recommendations

Why HPV Testing Is Not Available for Men

• The FDA has only cleared HPV tests for use with cervical specimens in women 1
• No HPV test for men has been approved by the FDA, nor has any test been approved for detection of the virus in areas other than the cervix 3
• The CDC explicitly recommends against using HPV tests to screen men due to the lack of an established screening pathway shown to reduce morbidity or mortality 2

Current Testing Limitations

• HPV testing should not be performed in the following situations 1:
  • Deciding whether to vaccinate against HPV
  • Providing care to persons with genital warts or their partners
  • Testing oral or anal specimens

Special Considerations for High-Risk Populations

While routine HPV testing is not recommended for men in general, certain high-risk populations may benefit from targeted screening:

• Men who have sex with men (MSM), particularly those who are HIV-positive, may benefit from anal cytology (anal Pap tests) rather than direct HPV testing 2, 4
• For men with anal and/or intra-anal warts, digital examination, standard anoscopy, and high-resolution anoscopy may be beneficial 2

Clinical Management Without Testing

Since HPV testing is unavailable for men, clinical management focuses on:

1. Visual diagnosis: The most common manifestation of HPV infection in men is genital warts, which are diagnosed by clinical visual inspection 1

2. Prevention strategies:

   • HPV vaccination for males aged 9-26 years (strongest recommendation for ages 9-21) 2
   • Consistent condom use (though not fully protective) 2
   • Limiting sexual partners 2

3. Partner considerations:

   • Partners in long-term relationships tend to share HPV 1
   • Even if testing were available, a negative result would not rule out HPV infection due to sampling limitations and the transient nature of detectable infection 2

Important Patient Education Points

When discussing HPV with male patients:

• Most sexually active adults will contract HPV at some point, though most never know it because infections are typically asymptomatic 2
• A diagnosis of HPV in one partner is not indicative of sexual infidelity 2
• Most HPV infections in men clear spontaneously without causing health problems 2
• Within ongoing sexual relationships, both partners are usually infected by the time one person is diagnosed 2

Future Directions

Research suggests that testing men for certain HPV types (such as oncogenic HPV16 or HPV18) as part of routine screening when their partner is positive for HPV might be beneficial 5, but this approach has not yet been incorporated into official guidelines or received FDA approval.