MIRAVISTA DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

AbstractCoccidioidomycosis is an endemic mycosis caused by the fungi Coccidioides immitis and Coccidioides posadasii and has been increasing over the last decade in the Southwestern United StatesThe most common clinical manifestation is primary pneumoniawhich causesof all community acquired pneumonias in endemic areasThe morbidity is substantialmedian duration of illnessdaystime to resumption of normal activitydaysand lost workdaysof patients were hospitalized with a calculated inpatient cost of $per patientand $million total costA California study reported annual costs of hospitalization was $millionDetection of anti Coccidioides antibodies provides the laboratory basis for diagnosis in most casesHoweverthe antibody tests may be negative in one quarter to one third of immunosuppressed patients and half of patients with primary pulmonary coccidioidomycosisA more sensitive enzyme immunoassay has been developed at MiraVista Diagnosticswith an overall sensitivity ofandin immunocompromised patientsAn additional limitation of the current antibody assays is turnaround time of at least one day and up to one weekDiagnosis by antigen detection was commercialized at MiraVista Diagnostics inThe sensitivity for diagnosis of moderately severe or severe casesmost of whom are immunocompromisedis goodCurrently the test is available only by sending specimens to MiraVista Diagnosticsresulting in turnaround times of at leastday and up todays if the specimen must pass through an intermediary reference laboratoryCombined antigen and antibody testing provides the highest sensitivity for diagnosis in severe casesin which rapid diagnosis may be lifesavingPoint of carePOCtesting for Coccidioides antigen and anti Coccidioides antibodies at the hospital at which the patient is evaluated will speed diagnosis and treatmentimprove outcome and reduce costThe objective of this phase I application is to develop lateral flow immunoassaysLFIfor rapid diagnosis of coccidioidomycosisTo accomplish this objectivemonoclonal antibodies recognizing the antigens found in patients will be produced and evaluated for development of Coccidioides antigen detection LFIsRecombinant or purified antigens recognizing antibodies detected in patients with coccidioidomycosis will be produced and used in developing anti Coccidioides antibody LFIsMiraVista Diagnostics hasyears of experience in development of fungal diagnostic assays and provision of CLIA certified fungal diagnostic servicesMiraVista s medical director is recognized as a leader in development of fungal diagnostic tests and use of these tests in care of patientsMiraVista scientistsproduction departmentand quality section possesses the expertiseresourcesand essential materials needed to accomplish these objectivesincluding production of Coccidioides antigensproduction of anti Coccidioides monoclonal antibodiesdevelopment and production of antigen and antibody detection LFIs and EIAsFurthermoreMiraVista Diagnostics is an ISOcertified facility experienced with design controlGMP practicesCLSI methods for assay validationconduct of the clinical trials to develop in vitro diagnostic devicesand FDAK submission