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E6/E7 mRNA detects E6/E7 mRNA in sufficient quantity to demonstrate integration and expression in a population of 2% of the ectocervical cells in cervical specimens in which high-risk HPV types have been detected. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
Failure to obtain adequate ectocervical, endocervical or vaginal cell population is suboptimal for evaluation. A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. This test detects cells overexpressing E6/E7 mRNA.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.
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