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Pap with HR-HPV isn’t enough…
HPV infection is usually transient, and self-resolving in most women under 30. However, persistent infection is more common with high risk types of HPV, and is a significant factor in the development of cervical cancer.

Infection with high-risk HPV types interferes with the normal cell function and expression of cellular gene products. In benign lesions, viral DNA is located extrachromosomally in the nucleus; in high-grade intraepithelial neoplasia, HPV becomes integrated into the host genome.

Data have shown that over-expression of HPV E6 and E7 oncoproteins is a critical and necessary step to the progression of cervical disease through their ability to disrupt cell proliferation. Early detection of these mRNA transcripts of E6/E7 in individual infected cells provides improved specificity by identifying not only the presence of the virus but also its viral activity. 


E-TECT® E6/E7 Oncogene Assay: Measuring Gene Expression In A Single Cell
The assay employs a novel in situ hybridization technique utilizing a cocktail of probes specific to multiple sites within the E6 and E7 genes to ensure the detection of mRNA transcripts for the most prevalent high risk HPV genotypes.



For more information about The FlowScript™ HPV Assay described above, please visit Enzo Life Sciences.
Clinical Relevance
  • Strong negative predictive value as compared to HPV DNA testing
  • High specificity for the most prevalent HR HPV subtypes
  • Validated with ThinPrep and SurePath specimens
 
Clinical Utility
E-TECT® HPV E6/E7 provides clinically relevant information at the single cell level. The results can guide physicians on whether colposcopy or follow-up screening should be the preferred courses of action; thereby preventing unnecessary emotional distress when receiving abnormal cytology and HPV test results. 


Reflex Options
  • Negative Cytology, HPV (+)
  • ASCUS Cytology, HPV (+)
  • LSIL Cytology 

Suggested Patient Triage
 

 Cytology Result

 HPV Result

 E-TECT® Result

 Follow-up

 Negative

 Screen Positive

 Negative

 Repeat in 1 year

 Negative

 Screen Positive

 Positive

 Repeat in 6 months

 Negative

 Screen Positive,
 16 or 18 Positive

 Positive

 Colposcopy

 ASC-US

 Positive

 Negative

 Repeat in 6 months

 ASC-US

 Positive

 Positive

 Colposcopy

 LSIL

 -

 Negative

 Repeat in 6 months

 LSIL

 -

 Positive

 Colposcopy