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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: $595,146.00
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
United States
DUNS: 078634704
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (775) 784-6264
Business Contact
Phone: (775) 223-6169
Research Institution

Mucormycosis is one of the deadliest of the invasive fungal infections. Mucormycosis occurs most often in
patients with hematological malignancies undergoing chemotherapy, patients who have received hematopoietic
stem cell transplants or patients with diabetes mellitus. Improved diagnosis is the most frequently noted unmet
need for management of the mucormycosis patient. Delays in treatment increase the mortality rate from an
already high 47% to 83%. Unlike other invasive fungal infections, there has been no known fungal biomarker for
diagnosis of mucormycosis. However, in our preliminary studies, a monoclonal antibody (mAb 2DA6) was
produced that has high reactivity with cell wall fucomannan of the Mucorales. A first-generation immunoassay
produced from mAb 2DA6 found fucomannan in serum, urine, broncho alveolar fluid and infected tissue from
clinically relevant mouse models of mucormycosis and in plasma and urine from human cases of mucormycosis.
The goal is an immunoassay that uses plasma or urine to rapidly diagnose early-stage mucormycosis. The target
population is individuals for whom diabetes mellitus or use of potent immunosuppressive drugs has led to a
dramatic increase in the occurrence of mucormycosis. The approach is an immunoassay for the presence of
fucomannan, a cell wall carbohydrate that is shared by the many Zygomycetes that produce mucormycosis. The
product will be a lateral flow immunoassay (LFIA) that is rapid, inexpensive, and easy to use.
There are four Specific Aims. Aim 1 will confirm reactivity of mAb 2DA6 across the various Zygomycetes that
produce mucormycosis. Aim 2 will optimize specimen treatment for detection of fucomannan by immunoassay.
Aim 3 will identify the immunoassay limit of detection needed for optimal assay sensitivity and specificity using
well characterized, prospectively collected samples from patients with mucormycosis or aspergillosis, as well as
control, not infected patients. Aim 4 will construct an advanced prototype LFIA that meets assay cutoffs for early
and specific diagnosis of mucormycosis.
This proposal addresses a critical unmet need for an increasingly common and fatal opportunistic fungal
infection. Clinical 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 aspergillosis. The study is the first ever to demonstrate and exploit a secreted fungal
biomarker for diagnosis of mucormycosis. Project preliminary results, coupled with the well-accepted clinical use
and commercial success of other immunoassays that target cell wall mannans for diagnosis of invasive fungal
disease, make the probability for commercial success very high.Mucormycosis is one of the deadliest of the invasive fungal infections. The goal of this study is a rapid and simple
diagnostic test that can detect early-stage infection. The 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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