LUMINOSTICS INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

ABSTRACT The ultimate goal of this project is CLIP CTan FDA cleared and CE marked smartphone based testminfor Chlamydia trachomatisCTinfections in women in over the counterOTCand point of carePOCsettingsCT is the most common bacterial cause of sexually transmitted infectionswith almostmillion new cases in the US each yearUntreated womenmostly in theage groupare at high risk of serious sequelae including pelvic inflammatory diseaseectopic pregnancyand infertilityCT infections are curable with a single pillbut the fact that they are asymptomatic in up toof those infected necessitates screening of high risk populations using accurate testing methodsCurrently recommended Nucleic Acid Amplification TechniquesNAATsare expensive and have slow turnaround timesseverely limiting their applicability for expanding testing coverageRapid POC tests can curb disease transmission by enabling a same day andquot test and treatandquotapproach and immediate partner notificationAn OTC test that can also be used in POC settings will also expand testing to the large swath of at risk women who do not seek testing due to embarrassment confidentiality concernsLuminosticsandaposCLIP CT is based on the use of andquot nanophosphorsandquotpersistent luminescent nanoparticlesas lateral flow assayLFAreporters in an immunoassay for CTA phone case like smartphone adapterin combination with a mobile appis used for result readout and analysis from the nanophosphor LFA using the phoneandapos s flash and cameraCurrent colorimetric LFAs for CT are andgtspecific due to the availability of good monoclonal antibodiesbut have very poor clinical sensitivity due to their high limit of detectionLODWe hypothesized that the vastly improved LOD of nanophosphor LFAs compared to colorimetric LFAs could result in clinical sensitivities approaching NAATsi eandgtWe obtained initial validation for this hypothesis in Phase I studieswhere CLIP CT prototypes with afold lower LOD than an FDA cleared colorimetric LFA for CT achieved a sensitivity ofand a specificity ofcompared to an FDA cleared NAAT in a small retrospective clinicalHaving validated the feasibility of nanophosphor LFAs for sensitive CT detectionthe following Specific Aims are proposed for Phase IIAimwill iteratively designdevelop and validate the ancillary hardware and software components of CLIPCT around the Phase I developed assayAimwill perform comprehensive analytical performance studies and a human factors validation studyIn Aimthe clinical performance of CLIP CT will be validated in a largenclinical study using prospectively collected specimensLuminostics has assembled a team of bioengineerschemistssoftware engineersmicrobiologistscliniciansand manufacturing experts to maximize the odds of successThe expected outcome of this Phase II project is the significant de risking of the final trial targeting FDAkOTC clearance for CLIP CT and the further validation of nanophosphor LFAs as a platform technology with potential applications in a variety of medical conditions that could use more sensitive POC tests NARRATIVE The lack of a sensitiveinexpensive and rapid test for Chlamydia in point of carePOCand over thecounterOTCsettings represents a significant obstacle to managing the public health burden of this Sexually Transmitted InfectionSTIthat disproportionately affects womenIf untreatedChlamydia can have disastrous consequences including infertilityThe opportunistic screening of high risk populations using highly sensitive POC and OTC tests presents the best chance of reducing its prevalenceIn this Phase II projectLuminostics will develop a rapidsmartphone based test for Chlamydia detection in womendesigned to give at home users as well as physicians minimally trained healthcare workers an unambiguouspositiveornegativeresult from non invasive samples in less thanminutes