Immunoassay for early diagnosis of mucormycosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI140817-01A1
Agency Tracking Number: R43AI140817
Amount: $297,133.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-11
Award End Date (Contract End Date): 2021-03-31
Small Business Information
1664 N. Virginia st., Reno, NV, 89557-0001
DUNS: 078634704
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (775) 376-1191
Business Contact
Phone: (775) 376-1191
Research Institution
Mucormycosis is one of the deadliest of the invasive fungal infectionsMucormycosis occurs most often in patients with hematological malignancies undergoing chemotherapypatients who have received hematopoietic stem cell transplants or patients with diabetes mellitusImproved diagnosis is the most frequently noted unmet need for management of the mucormycosis patientDelays in treatment increase the mortality rate from an already hightoUnlike other invasive fungal infectionsthere has been no known fungal biomarker for diagnosis of mucormycosisHoweverin our preliminary studiesa monoclonal antibodymAbDAwas produced that has high reactivity with cell wall fucomannan of the MucoralesA first generation immunoassay produced from mAbDAfound fucomannan in serumurinebroncho alveolar fluid and infected tissue from clinically relevant mouse models of mucormycosis and in plasma and urine from human cases of mucormycosisThe goal is an immunoassay that uses plasma or urine to rapidly diagnose early stage mucormycosisThe target population is individuals for whom diabetes mellitus or use of potent immunosuppressive drugs has led to a dramatic increase in the occurrence of mucormycosisThe approach is an immunoassay for the presence of fucomannana cell wall carbohydrate that is shared by the many Zygomycetes that produce mucormycosisThe product will be a lateral flow immunoassayLFIAthat is rapidinexpensiveand easy to useThere are four Specific AimsAimwill confirm reactivity of mAbDAacross the various Zygomycetes that produce mucormycosisAimwill optimize specimen treatment for detection of fucomannan by immunoassayAimwill identify the immunoassay limit of detection needed for optimal assay sensitivity and specificity using well characterizedprospectively collected samples from patients with mucormycosis or aspergillosisas well as controlnot infected patientsAimwill construct an advanced prototype LFIA that meets assay cutoffs for early and specific diagnosis of mucormycosisThis proposal addresses a critical unmet need for an increasingly common and fatal opportunistic fungal infectionClinical use and market size for the test would be identical to currently available immunoassays for diagnosis of invasive aspergillosis because mucormycosis is on the differential diagnosis for patients with suspected invasive aspergillosisThe study is the first ever to demonstrate and exploit a secreted fungal biomarker for diagnosis of mucormycosisProject preliminary resultscoupled with the well accepted clinical use and commercial success of other immunoassays that target cell wall mannans for diagnosis of invasive fungal diseasemake the probability for commercial success very high Mucormycosis is one of the deadliest of the invasive fungal infectionsThe goal of this study is a rapid and simple diagnostic test that can detect early stage infectionThe results will be improved patient survival due to earlier diagnosis and prompt administration of the appropriate antifungal treatment

* Information listed above is at the time of submission. *

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