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Middleton, WI, United States

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2016

Expensive equipment highly trained personnel and the need for a clinical laboratory setting precludes routine nucleic acid testing NAT for infectious disease in most of the developing world and even in many resource limited parts of the United States leading to wide disparities in health care worldwide A fast sensitive low cost but a facile NAT method for robust detection of specific agents at the point of care POC would help bring molecular diagnostics to everyone The goal of this application is to demonstrate feasibility of a complete field appropriate molecular detection system suitable for use in low resource settings for the detection of three important arboviruses Chikungunya CHIKV Zika ZIKV and dengue DENV The innovative technology that is the basis of this application is a new thermostable polymerase OmniAmp which has innate reverse transcriptase RT activity OmniAmp is suitable for application in a promising NAT alternative to the polymerase chain reaction PCR called loop mediated isothermal amplification LAMP Since LAMP is isothermal it does not require specialized instrumentation plus it is much faster than PCR LAMP is also resistant to inhibitors in crude sample preparations The proposed assay will be based on LAMP using OmniAmp polymerase and performed on a simple easy to use automated molecular detection MDx platform Total assay time will be minutes with minimal hands on time and without need of any additional equipment such as pipettes centrifuge etc Results will be displayed on screen as positive or negative for a specific pathogen minimizing error s caused by user interpretation LAMP assays for detection of all major lineages of CHIKV and ZIKV including strains now circulating in the Americas and all serotypes of DENV will be developed Performance of LAMP assays will be compared to that of reference real time RT PCR methods For field use a simple and rapid sample preparation method for extraction of nucleic acid from samples whole blood and serum will also be developed In order to increase the shelf life of reagents amplification reagents will be dried down Analytical sensitivity and specificity will be evaluated by testing whole blood and serum samples by spiking them with different titers of CHIKV ZIKV and DENV serotype both individually and co infection By combining Lucigen s capacity in amplification and detection with the expertise in arboviral research and fundamental capability provided by the University of Texas Medical Branch a molecular detection system will be developed for detection and differentiation of CHKV ZIKV and DENV that can be implemented almost anywhere worldwide Successful completion of this project will lead to Development of molecular diagnostic assay for detection and differentiation of three important arboviruses CHIKV ZIKV and DENV at POC Total assay time of minutes including sample preparation and run time Detection of multiple targets in a single run from single sample prep Dried reagents for storage at ambient temperature A technology platform that can be adapted for the detection of other pathogens A simple and easy to use molecular test for detection and differentiation of arboviruses at the point of care would bring the power of molecular diagnostics to low resource settings The goal of this application is to demonstrate feasibility of a complete field appropriate molecular diagnostic system for the detection of three important arboviruses Chikungunya Zika and Dengue that can be used anywhere in the world with minimal infrastructural support and training The results of this assay will be available in minutes allowing healthcare providers to initiate appropriate actions

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2014

Human cytomegalovirus (CMV) infection causes more cases of congenital disease than 29 currently screened conditions in the US combined & several newborn screening disorders in EU countries. Congenital CMV infection rate is 0.7% in developed countries with 18% of infected newborns developing permanent hearing & vision loss, or intellectual disability (5,000 in the US each year). Ninety percent of CMV infected newborns are asymptomatic at first, but many will suffer moderate to severe sequelae, the economic burden of which is estimated at >$1B. This public health burden can be reduced through early detection followed by intervention to improve secondary outcomes. PCR amplification has been used to identify CMV followed by intervention to improve secondary outcomes. PCRA amplification has been used to identify CMV DNA, but a molecular diagnostic test for newborn CMV testing has not been FDA cleared. Lucigen is developing a new diagnostic platform to achieve 30 minute sample-to-answer point-of-care molecular testing of infectious diseases, with CLIA-waiver as the ultimate goal. Lucigen's prototype CMV molecular test platform will achieve high sensitivity & specificity at point-of-care in the newborn nursery, enabling early detection of infected infants before symptoms occur. This information will allow preemptive intervention that could limit certain long term-disabilities, thereby providing patients with improved health care outcomes.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2015

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

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 698.42K | Year: 2015

DESCRIPTION provided by applicant A post antibiotic era of multiple drug resistance has begun to threaten the health and well being of mankind A crucial limitation in economically converting untapped natural product potential to final scalable production is the lack of next generation tools to effectively access the full medicinal impact of natural environments This project utilizes innovative technologies to capture entire small molecule pathways and express them for the first time in E coli resulting in a potent pipeline of novel environmentally derived therapeutic compounds There are two unique components available to achieve this goal A new strain of engineered E coli to support many of the unique building blocks needed for expression of natural product biosynthetic pathways and A BAC library of clones containing entire small molecule pathways up to kb to be assayed for expression of anti bacterial activities against the ESKAPE series of pathogens The outcomes of this research are expected to significantly accelerate the discovery and production of novel antimicrobial compounds PUBLIC HEALTH RELEVANCE This proposal is designed to accelerate the expression and discovery of environmentally encoded complex natural products Success will provide new antimicrobial compounds with the potential for more efficient economical rapid and effective clinical translation and large scale production

Lucigen Corporation | Date: 2014-01-10

Described herein are isolated polynucleotides that encode a fluorescent protein which is at least 80% sequence identical to a protein selected from the group consisting of SEQ. ID. NOS: 2, 4, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, 58, 62, 66, 70, and 74. Also described are expression constructs containing the polynucleotides, transformed host cells containing the expression constructions, the encoded fluorescent proteins themselves, and methods of using the nucleotides and encoded fluorescent proteins for bioanalytical research.

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