Bloodstream infection detection directly on whole blood
openNIAID - National Institute of Allergy and Infectious Diseases
Bloodstream infection detection directly on whole blood
Summary
Yeast bloodstream infections are life-threatening, affecting approximately 50,000 patients
annually in the United States, with mortality rates exceeding 40%. Early administration of
antifungal therapy is critical for improving survival rates. However, the current diagnostic gold
standard, blood culture (BC), requires one to five days, delaying crucial treatment decisions. To
address this gap, Scanogen has developed an automated platform for the rapid, comprehensive,
and cost-effective identification of yeast in whole blood without the need for BC. This platform is
powered by Single MOLecule Scanning (SMOLT), an innovative method for sample preparation
and molecular detection.
In this Commercialization Readiness Pilot (CRP) Program, we aim to build on the success of our
SBIR Phase II project, where we achieved or surpassed all milestones. During this phase, we
developed, automated, and clinically tested the SMOLT-Yeast assay. The assay has
straightforward workflow: the user inserts the patient’s blood sample, collected in a vacutainer,
into a disposable cartridge, which is then analyzed by a desktop instrument. The assay
demonstrated exceptional performance, with a detection limit of 1 CFU/mL across 11 yeast
species, a clinical sensitivity of 96.7%, and a clinical specificity of 99.8%. Following stakeholder
recommendations, we also included Candida auris in the test panel.
In this CRP, we will focus on scaling production and meeting regulatory standards. Specifically,
we will develop manufacturing processes for reagent production (Aim 1) and cartridge production
(Aim 2) in compliance with FDA regulations. Additionally, we will enhance the instrument software
by incorporating cybersecurity measures and Laboratory Information System (LIS)
communication capabilities, and transfer the design to production (Aim 3). Our team comprises
highly skilled assay development scientists responsible for the SMOLT technology and
experienced engineers.
This platform has the potential to greatly improve patient outcomes by delivering rapid and
accurate results, allowing timely antifungal treatment for yeast bloodstream infections. Upon
completion of this project, we will be positioned to initiate the pivotal analytical and clinical studies
necessary for FDA clearance.
Up to $969K
health research