cfHPV-DNA Assay:


cfHPV-DNA represents a promising surrogate of disease burden in patients with HPV-driven cancers.

Applying ultra-sensitive technology to detect and quantify circulating HPV-DNA using HPV-SEQ is an innovative and exciting step forward in the development of more targeted approaches when managing HPV-associated cancers. HPV-SEQ has high analytical and clinical sensitivity, with the ability to reliably and consistently detect as low as 2 copies of HPV 16 and HPV 18 DNA.


Clinical sensitivity of detecting cfHPV-DNA in pretreatment baseline using HPV-SEQ was 97.6% (95% CI, 91.5% – 99.7% [80 of 82 tests])

Intended uses

cfHPV DNA panel

Clinically relevant gene regions

Intended uses

HPV-SEQ & HPV-related cancers

HPV 16, HPV 18

  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance
Test specifications

Cell-free DNA analysis for solid tumors

Sample types accepted

  • Whole blood
  • Frozen plasma
  • Purified cfDNA

Sample requirements

  • 2x10 mL blood collection tubes required, additional tube may be recommended for certain studies
  • Sysmex Inostics' specimen collection and shipping kits include Streck blood collection tubes
  • Plasma or purified cfDNA from samples collected in Streck or EDTA tubes is acceptable

Turnaround time

7 – 10 Business days