Human papillomavirus (HPV) infection is the cause of virtually all genital warts (condyloma), and cervical and anal cancers. The Company has developed a novel assay for detecting integrated HPV DNA in cervical cells, which has the potential to more accurately predict disease progression and prognosis. Using this novel assay format on cervical cell samples from HIV-positive women, this SBIR will investigate HPV types involved and whether HPV DNA has integrated into the host genome. A rapid cell-based in situ hybridization assay for screening cervical cell samples from HIV-infected women is urgently needed because conventional HPV diagnostic methods such as simply determining whether an infection involves high-risk or low-risk families are not be as useful in this patient population. In immunocompetent women, most infections, regardless of viral type, resolve spontaneously over several months. HPV prevalence in asymptomatic immunocompetent women ranges from 10% to 20% and, in most cases, involves infection only by a single viral type. In contrast, typically >70% of HIV-positive women have HPV infection which results in cervical and anal cell abnormalities. Viral persistence is greatly increased, as is the frequency of multiple type infection. Higher relapse rates after condyloma treatment is seen, as well as differences in HPV strain prevalence.
