LUCIGEN CORPORATION — Department of Health and Human Services SBIR Phase I: NIDCR

Description

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 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 of the US population is infected with oral HPV and with HPV Annually about 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 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 Lucigenandapos s POC is due to enter clinical trials early 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 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 PUBLIC HEALTH RELEVANCE Human Papilloma virus HPV is among the most common and deadly sexually transmitted infections and is responsible for both benign genital warts and genital and oral cancers These infections are increasingly common in the oral cavity and often go undiagnosed since there is no FDA approved test for HPV in the mouth or throat Delayed diagnosis prevents early intervention that can be lifesaving The dentist office is an attractive point of testing for oral infections like HPV however this will require an HPV test suitable for use by the available personnel using the limited diagnostic equipment available in a dentist office Lucigen in collaboration with the University of Pennsylvania proposes to provide molecular diagnostic tests based on isothermal DNA amplification suitable for screening for HPV in the dentist office These tests will be simple enough for FDA clearance for use at point of care with minimal training and equipment and will be an important part of the early detection and intervention for HPV infection