The home pregnancy test has become a cheap and effective option across the world, helping women to become more aware of their pregnancy status for decades. Diagnostic tools such as the pregnancy test are powerful but also few and far between.
UW-Madison professor of biomedical engineering David Beebe and his colleagues at his company Salus Discovery have used lateral flow technology, like in pregnancy tests, to create one of the first cheap and effective tuberculosis (TB) diagnostic assays. Supported by a $2.6 million grant from the Gates Foundation, Salus Discovery set out to fulfill the pressing global need for a simple TB test.
Current diagnostic assays for TB involve lengthy DNA extraction and analysis from sputum samples which a patient must cough up. This new assay detects protein rather than DNA; Beebe and collaborators use lipoarabinomannan (LAM) protein from urine samples as a biomarker to detect TB.
Beebe explained that his team originally “didn’t know anything about what’s called lateral flow technology … but because we didn’t know anything about it, we weren’t constrained in any boxes, because of that we came up with a way to enhance lateral flow assays that someone who’s been working in lateral flow assays for 30 years would never have thought of.”
Throughout the entire process, Salus Discovery has worked to ensure that the assay would be sturdy enough for widespread use in the developing world, where conditions like extreme temperature, contaminating dust and limited medical labs would not be an obstacle to patient diagnosis. This approach reflects Beebe’s longstanding commitment to global health efforts in Africa, with more than 10 years partnering with organizations on various projects.
Looking forward, Salus Discovery will seek World Health Organization certification for their TB test and then begin to evaluate manufacturing options. It’s likely that they will end up partnering with one or more companies to complete the manufacturing of both the device and the antibody itself. They also plan to do more rigorous testing in the field to ensure effectiveness under extenuating circumstances.
Another thing to consider is the potential applicability of this biomarker based lateral flow assay to other diverse conditions.Many other diseases have so-called biomarkers that could potentially be the basis of an assay, like the LAM protein is for TB.
This is a hot topic in the biomedical sciences, exemplified by the very recent development of a blood test for dementia by Katsuhiko Yanagisawa’s group in Japan. Yanagisawa’s assay tests for high levels of a protein called amyloid-beta, a condition that often indicates early progression of dementia.
“Lateral flow pregnancy tests are widely used, and [the TB assay] really just builds upon that, so we do think it absolutely has applications in other conditions. Mental health for example is on our list of where we think this technology might have potential,” Beebe said.
Salus Discovery and their new TB lateral flow assay are one of the finest examples of university research applied to enterprise. Almost all of Salus Discovery’s employees came directly from Beebe’s UW-Madison lab. Many of the most accomplished research professors at UW-Madison start their own spin-off companies to take their innovations further. Most notably, James Thompson — who first derived human embryonic stem cells in 1998 — started Cellular Dynamics International, which was eventually acquired by Fujifilm for more than $300 million.
The lateral flow TB test is a collaboration of university research, entrepreneurial innovation and philanthropic goals. Beebe said that if you care and want to make a difference, “get to Africa, get to India, get to wherever it is you actually want to help people, spend some time there and actually understand what the real problems are.”
