Australia's Genera Biosystems says results from a pilot clinical study indicate that its PapType human papillomavirus detection and genotyping test shows an improved pre-cancer detection rate over Qiagen's Hybrid Capture 2 test, the only cervical cancer screening diagnostic approved by the US Food and Drug Administration.
Out of 100 specimens tested, obtained from women who had presented at the hospital with abnormal Pap smear results, HC2 returned a false negative rate of 27%, compared to just 7% for PapType. A false negative result is obtained when the HPV test fails to correctly predict the presence of high-grade precancerous lesions in the cervix, and can have important consequences for the patients concerned.
Suzanne Garland, chairperson of Genera's advisory board, said: "in a sense, this is not a surprising result for PapType, given the nature of the technology. Nevertheless, this is an important result, in that potentially, a doctor can have greater confidence in the results from their HPV test."
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