Test Overview
Digital droplet PCR
High-risk HPV (hrHPV) is associated with head and neck, cervical, vulvar, penile, and anal cancers. HPV can be either episomal or integrated into the tumor genome, and fragments of HPV DNA are shed into the bloodstream as part of normal tumor proliferation.
The MyHPVscore plasma ctDNA test assesses circulating cell free DNA for hrHPV tumor DNA associated with HPV-positive cancers, including HPV16, -18, -31, -33, -35, and -39, types for which ~99% of HPV-positive head and neck cancers are attributable. The test uses digital PCR water-emulsion droplet technology, in which the DNA template is fractionated in thousands of droplets. Amplification occurs in each droplet with multiplexed primer/probe sets, and calculation of the positive droplets gives precise quantification of each target.
Interpretive report provided.
*Reference ranges may change over time. Please refer to the original patient report when evaluating results.
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
This test may fail to detect HPV copies below the limit of detection of the assay. Rare HPV polymorphisms may lead to false negative results. The clinical implications of the findings as indicated in the test report may change based on evolution of the scientific literature.
This test is for the purpose of detecting hrHPV in plasma. While the test has been designed to distinguish between tumor-derived material and infection-derived material, there may be instances in which this is not possible.
Test Details
5-12 days
Specimen Requirements
Blood collection in PAXgene Blood ccfDNA or Streck Cell-Free DNA Tube with 10 mL draw preferred. Store and transport at room temperature. Specimens between 6-30°C are viable for 7 days. Off-site specimens are received for processing Monday through Friday only. Please account for transport/ shipping time when performing collection.
Additional Information
By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test may include blood collection billed as a separate additional charge.