Salus Discovery, LLC was awarded a $2.6 million grant from the Bill & Melinda Gates Foundation to advance development of a non-sputum based point-of-care tuberculosis triage test. In 2014, the World Health Organization (WHO) identified this test as a specific global need. Salus Discovery, led by co-founders Dr. David Beebe and Dr. Scott Berry, will oversee the 30-month project, which also involves eight subgrantees from six different countries. Salus President Dr. David Beebe says, “We’re excited to lead an exceptionally talented group of international collaborators toward a goal that’s incredibly important to global health.” It is estimated that a diagnostic test for tuberculosis with sufficient sensitivity and specificity that is adaptable in areas with limited infrastructure would be used 100 million times per year and save at least 400,000 lives annually [Keeler et al., Nature 2004].

The simple, low-cost triage test will be designed for use in remote healthcare settings, bringing the test closer to the patients that need it most. The technology will differ from traditional tuberculosis assays by targeting a biomarker in urine versus relying on a difficult-to-collect sputum sample. It will also feature a straightforward lateral flow assay readout (provided by Mologic Ltd., United Kingdom) similar to a home pregnancy test, which will allow for interpretation without an expert. The test aims to accurately detect tuberculosis in both HIV-positive and HIV-negative adults and children, addressing several limitations of current methods. Most importantly, it will bring tuberculosis tests to those without current access.

Increased test sensitivity will be made possible by utilizing Salus Discovery’s ESPTM (Exclusion-based Sample PreparationTM) technology, which has been in development for over eight years, and validated by a previously-funded Gates Foundation collaboration to implement a clinically-studied HIV viral load assay in Uganda. Dr. Scott Berry, Chief Scientific Officer of Salus reflected, “That project really illuminated the value of partnering with your target user early on in the design process. As collaborations like this mature, ‘my assay’ becomes ‘our assay,’ which is wonderful, but it also builds acceptance for implementation down the road.” This model will be reinforced by the current project, as ESPTM will allow for 100-fold concentration of lipoarabinomannan (LAM), a biomarker excreted in the urine of tuberculosis patients, with the goal of detecting as little as 10 pg/mL with 90-95% sensitivity.

Salus Discovery was founded in 2013 to commercialize two intellectual property (IP) portfolios licensed from the Wisconsin Alumni Research Foundation. Salus recently doubled its space at 110 E. Main St, Madison, WI and partnered with Gilson, Inc. to bring its first product, EXTRACTMANTM, to market in 2016. In addition, Salus has received multiple Small Business Innovation Research (SBIR) grants in areas such as HIV and cancer research, and established partnerships with many industry-leading companies to apply Salus technology across a range of markets. As stated by Dr. Beebe, “Technologically, this project aligns perfectly with our long-term vision for Salus as a company. It really enables us to grow the business while developing a product with the potential to improve health care for millions. While the focus of this project is tuberculosis in the developing the world, the technology will find utility in a number of other applications in the developed world.”

Field testing in both South Africa and Ethiopia will validate assay functionality with hundreds of “real-world" samples from patients with either confirmed or suspected tuberculosis. Following successful clinical evaluation, Salus intends to seek approval from regulatory agencies and WHO endorsement.

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