Parent Project Abstract
HLS17-03 Anemia, or low blood hemoglobin levels, is a public health problem affecting over 2 billion
people worldwide. Over 1 billion of people affected live in low-resource settings. Currently, anemia is typically
diagnosed with a complete blood count (CBC) via a clinical hematology analyzer that is clinic or hospital-based.
To that end, Sanguina has completed development of a first generation AnemoCheck test, a disposable, color-
based test for screening and monitoring anemia. AnemoCheck utilizes one drop of blood (5µL) from a finger
stick. Blood is then mixed with our assay components and within two minutes, a redox reaction between the
assay’s reagents and the hemoglobin in the patient’s blood will lead to a specific color change of the assay that
correlates with the patient’s degree of anemia, if any. Hence, this simple assay with a straightforward, color-
based visual readout is similar to a urine analysis dipstick and does not require any electricity nor additional
equipment. We have published clinical assessments successfully completed on AnemoCheck technology
(Tyburski, et al, J Clin Invest. 2014 McGann et al, AJH, 2015) and fully developed this solution-based first
generation product. However, we realize the limitations on our current test for use in low-resource settings. Many
resource-poor regions cannot afford standard hematology analyzers or store them in current infrastructure.
Additionally, although several point-of-care and portable anemia diagnostic assays exist, there is currently no
inexpensive, disposable, test robust enough to handle storage in extreme temperature’s (40-60°C) often
experiences by remote, low-resource settings. Therefore, a robust disposable test for detecting or monitoring
anemia akin to point-of-care testing would enable populations in low resource settings to diagnose and screen
for anemia in relatively remote settings. To that end, Sanguina has recently developed modified chemistry,
utilizing dry components we call AnemoCheck-D, which has the potential to be stored for extended periods in
extreme environments and serve low-resource setting populations.
In this Phase I SBIR, we plan (Milestone 1) to develop robust dry form chemistry, optimizing each
ingredient for accuracy and stability and (Milestone 2) develop robust assay packaging specifically suited for
target low resource setting storage in extreme temperatures. We propose to evaluate the robustness of the assay
by performing verification testing, interference testing, and a (Milestone 3) conduct a pilot clinical assessment
testing within a target sickle cell population, with a head-to-head comparison with a standard clinical hematology
analyzer. Comprised of a successful serial bioentrepreneur, a clinical hematologist/bioengineer, a renowned
chemist, and a bioengineer/original inventor of the POC anemia test, our interdisciplinary team that leads
Sanguina, LLC will ensure the success of this project. Completion of these Phase I milestones will enable us to
put a design lock on the chemistry of the assay, finalize our product with packaging and labeling and create a
manufacturing plan that is specifically suited and cost-effective for low-resource settings while remaining feasible
for Sanguina. This work will feed into a Phase II, where we plan to conduct larger clinical assessments to satisfy
regulatory and quality requirements specific to target regions. Ultimately, our AnemoCheck-D test could offer
affordable anemia testing for a variety of settings and populations, worldwide. Ultimately, availability of screening
can help direct treatment of anemia, the world’s most common blood disorder, improve clinical outcomes and
save lives.
