A Microfluidic System for POC Molecular Diagnosis of HPV in Oral Fluids

Lucigen Corporation, Middleton WI

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Abstract

? DESCRIPTION (provided by applicant): The human Papilloma Virus (HPV) causes a wide variety of diseases in humans including squamous papilloma, focal epithelial hyperplasia, verruca vulgaris and condyloma acuminatum. In addition to benign diseases, HPV infection is implicated as an etiologic agent in malignancies including cervical and anogenital cancer. HPV-16 has been identified as the most common HPV genotype associated with oropharyngeal carcinoma. Morbidity / mortality rates associated with these diseases can be substantial, particularly when diagnosis is delayed. According to recent estimates, 7% of the US population is infected with oral HPV and 1% with HPV-16. Annually, about 8,400 people in the USA are diagnosed with cancers of the oropharynx that may be caused by HPV. It is projected that the number of HPV-related oropharyngeal cancers will increase significantly in the future. Currently, HPV detection is carried out in centralized laboratories. The availability of a chair-side molecula test will allow dentists to detect HPV 16 and use the test results to guide patient management. Early detection of HPV-related cancers will reduce morbidity, mortality, and cost. The dentist office is a critical point of intervention for screens for HPV and other infectious agents in the oal cavity. The long-term goal of this project is a multiplex screening platform for HPV and other viral, bacterial and fungal pathogens that go undiagnosed until they have progressed to an advanced stage and are increasingly harmful to health and more difficult to treat. The isothermal amplification chemistry under development is versatile and tests for several pathogens detectable in the oral cavity are under development. Providing tests that can be performed at point of care in the dentist office by a hygienist with no training in diagnostics are part of a company-wide strategy to enter the molecular diagnostics market by supplying the first true point of care molecular diagnostic devices. The first of Lucigen's POC is due to enter clinical trials early 2015. CLIA-waiver will require a level of design well beyond the typical diagnostic device to allow simplicity for use without extensive training or additional equipment for sample preparation. No such CLIA- waived, point of care molecular devices are currently available for any disease or sample type, making this proposal highly innovative. Alternative POC tests are not sensitive or specific enough for reliable diagnosis. Available molecular diagnostics require expensive, complex instrumentation, extensive training for operation and interpretation, and separate sample processing. Lucigen will collaborate with University of Pennsylvania (Penn) to develop an inexpensive, automated, POC device for molecular detection of HPV 16 in saliva. Lucigen will develop the isothermal DNA amplification mixes suitable for use with the Penn-designed multifunctional, isothermal enzymatic amplification reactor for nucleic acid detection. Phase I will focus on assay and prototype (breadboard) development and will provide a proof of concept of the diagnostic device.