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Alternative Name
HPV DNA, HPV genotyping (not for Pap), human papillomavirus, HPV Tissue Testing
Test Description

HPV DNA Tissue Testing is peformed on FFPE tissue. It uses PCR and fragment analysis for qualitative detection and genotyping of human papillomavirus (HPV) low risk types 6/11 and high risk types 16, 18, 31, 33, 45, and 58. When detected, specific genotypes are identified except for 6 and 11 which cannot be distinguished from each other and are reported as positive for the combination 6/11.

Clinical Significance

HPV DNA testing on FFPE tissue in head and neck squamous cell carcinomas (HNSCC), anogenital, and cervical lesions provides a complementary or alternative method to testing by p16 IHC or HPV ISH. In anogenital specimens, testing can distinguish presence of low-risk HPV types 6 and 11, associated with benign warts, from high-risk types which are associated with approximately 90% of anal cancers, 40% of vaginal cancers, and 40% of penile cancers. HPV is detected in up to 60-70% of oropharyngeal cancers and approximately 30% of HNSCC overall. HPV status serves as a prognostic marker head and neck cancer. Patients with HPV-positive cases have improved response to treatment and longer survival than patients with HPV-negative tumors in clinical trials.

Specimen Requirements
  • FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at thickness of 5-10 microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

CPT Code(s)*
Turnaround Time

5 - 7 DAYS

Level of Service

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.