Genera Biosystems Releases Results on HPV Detection Assay

Genera Biosystems has released the results of a major clinical study on its PapType Human Papillomavirus (HPV) detection assay, carried out in conjunction with the Royal Women’s Hospital (RWH), Melbourne, Australia. The RWH is a World Health Organisation Reference Centre for the study of HPV.

The study was carried out on specimens collected from 894 women who were referred to the hospital for further examination, after receiving abnormal pap smear results. In addition to being tested with PapType, the specimens were also tested using Hybrid Capture 2, manufactured by Qiagen.

The objective of the study was to compare how well the two tests performed in the detection of histologically proven high grade cervical pre-cancerous lesions – that is, high-grade precancerous changes, identified and confirmed by a pathologist examination of tissue specimens.

Critically, significantly fewer false negative results were returned by PapType than by HC2. the latter returned 111 false negatives out of the 531 specimens shown by histology to be positive for cervical pre-cancer (a rate of 20.9 percent), compared to just 47 from the former (8.9 percent).

The study also showed that, as the cervical pre-cancer advances towards full-blown cancer, PapType’s likelihood of detecting it also increases. The study involved 327 women who were histologically shown to have CIN3 (the most serious form of cervical pre-cancer), or actual cancer. PapType had a false negative rate amongst these women of just 5.5 percent, compared to 16.2 percent for HC2.

Three of the HC2 false negatives were called as “Indeterminate” by PapType. An “Indeterminate” result occurs when the test is unable to detect any human DNA in the specimen, indicating the possibility of specimen mishandling.

PapType is not only able to detect the cancer-causing types of HPV, but can simultaneously and specifically identify the different genotypes causing the infection.