MD HPV Liquid Biopsy

Human papillomavirus (HPV) infection has been etiologically linked with oropharynx carcinoma (OPC). During oncogenesis, papillomaviral genome integrates into the host chromatin, which can be viewed as a genetic "truncal" event for HPV-positive OPC. In patients with OPC, detection of HPV viral products at diagnosis supports the interpretation as HPV-positive OPC. In patients with a known history of HPV-positive OPC, detection of HPV in post-treatment setting can support the detection of residual disease in appropriate clinicopathologic context.

Circulating cell-free DNA (ccfDNA) is isolated from the plasma sample and a droplet digital PCR using HPV-type specific TaqMan probes is performed to detect HPV in the sample. This HPV type-specific PCR assay detects sequences at E6 and/or E7 region of the envelope gene in the HPV genome. Wildtype sequence of ERV3, an endogenous retrovirus found in the human genome, is utilized as an internal control.  

• The test is designed to specifically detect the presence of HPV16, HPV18, HPV33, HPV35 and HPV45 DNA in circulating cell free DNA. It does not screen for other HPV genotypes or any other viruses.
• A minimum of 10,000 total droplets (with and without a DNA template) are required for results interpretation and accurate quantitation.
• Viral load is calculated as the copies of virus detected per mL of plasma.
• The limit of reporting HPV copies of this test is 20 HPV copies/mL plasma. Values below this cut-off cannot be quantitated. A qualitative report is issued for positive cases with <20 HPV copies/mL plasma.
• The samples are identified as “baseline” and “follow-up” to allow comparison between different timepoints.
• Due to the biological and technical factors affecting the detection rate of mutation in ccfDNA, caution should be exercised in interpreting ddPCR-based ccfDNA results for patient care. A correlation with clinicopathological features and tissue genotyping results is recommended for a complete evaluation.
  

14 working days 

30 ml peripheral blood (PB) in Cell-Free DNA BCT® Streck Tube, sent at room temperature

81479

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer who is being billed.