Every minute, someone in the world dies of tuberculosis (TB). Eradicating this killer disease is a major goal of the World Health Organization, but up until now, there has been no quick, accurate and affordable way to test for active TB.
But if all goes as planned, TB Biosciences — co-founded by Dr. Sam Niedbala of Lehigh University, Drs. Suman Laal and Susan Zolla-Pazner of the New York University School of Medicine, and Drs. Daniel Malamud and William Abrams of the NYU School of Dentistry — will be able to provide just such a test to populations in the most dire need.
Niedbala, a chemistry professor at Lehigh, is a co-founder and former CSO of OraSure Technologies, which manufactures oral fluid diagnostic and collection devices, including rapid tests for detection of the HIV virus.
Now he and his partners are working on a blood testing device that can identify biomarkers for TB, proteins discovered by examining the TB bacteria genome. These markers are only present when TB is active and communicable. They will conduct clinical trials in Kenya and India this year.
What inspired you to start TB Biosciences?
There are probably two infections in the world that are most prevalent. One is HIV, and the second, which is even more impactful in many ways, is tuberculosis. We took on the first (in founding OraSure), and now we’re taking on TB.
Unlike HIV, TB behaves differently in different parts of the body. When it’s latent, it doesn’t show itself very much, but when it becomes active it behaves differently. Researchers have never been able to find a set of markers that show that TB is active, so it’s been impossible to develop a very reliable and rapid test. It has plagued humanity for centuries.
About two-thirds of the world has TB, but it’s latent TB. When it progresses to active TB, you spread it by coughing. In countries where TB is widespread, they need to find out who has active TB, so they can stop the transmission. The treatment methods for TB are actually very inexpensive, so if you can find the people who are positive, you can cure many of them. But you can’t give those drugs to an entire country, because then they can develop drug-resistant strains of TB.
If you take a billion or more people with an infection that they can’t find, it could wreak havoc on a society. TB is endemic in Brazil, Russia, India and China — the world’s fastest-growing economies.
How does your product work?
It’s a small foil pack that contains a little plastic cassette; in that is a test strip. (The clinician) will use a lancet to prick the patient’s finger and get a drop of blood, put it on the test strip, and add a few drops of liquid. In 15 minutes, if there’s a line, it will be positive; if there’s no line, it’s negative.
Where are you in your commercialization process?
We have the technology and we’re developing the test. It will take a couple of years to go through clinical trials and approvals in the various countries. Our goal is to do all the developmental work here in Pennsylvania, and then we’ll decide where we’re going to do the manufacturing. We expect part of it to be done here in the Lehigh Valley, but we may have requirements to do it in other parts of the world. One of our goals is to create jobs in Pennsylvania.
We have hired our first several employees, who are working at the Firehouse and also on campus at Lehigh University. We also sponsor researchers at Lehigh and NYU, who are helping with some of the background work.
Have you taken advantage of any resources to help launch the company?
The Northeastern Pennsylvania Ben Franklin Technology Partners have provided funding to go to the next phase. (OraSure also started in the Ben Franklin incubator). We received grants from the National Institutes of Health, and we’re also partially funded by Originate Ventures and the NYU School of Medicine venture funding.
How will the clinical trials be conducted?
There are two main phases: The first is to collect samples, bring them back to the lab, test them with prototype devices, and show that you get accurate results. The second phase is demonstration studies, where you go to various sites, give the people who will actually perform the test your product, and have them read the instructions and use it. We’ll be testing thousands of people.
What is your biggest challenge in getting TB Biosciences off the ground?
There are few people who believed that we would have a technology capable of detecting active TB. This is like a ‘Holy Grail’ kind of project. For years, they would say in the textbooks that detecting TB this way doesn’t happen. This is something people have been searching for for a long time. We have a lot of work to do yet, but the biggest problem we have is skepticism. We’re either going to be really successful because we have an answer, or we will fail very quickly. If it works, it will impact a lot of people.
Will there be a market for your product in the United States?
There will be a market in the U.S. and the Western world for a second-generation product that’s already on the drawing board. It’s a different kind of market, because we’re looking for much earlier detection of people who are transitioning from latent to active TB. The trials here will be designed differently, and if successful will save a lot of people here from taking unnecessary drugs. It would be at a much-reduced cost from current tests. TB for us here is something the CDC keeps its eye on, because if it gets a hold in the US population, it would wreak havoc. For people with compromised immune systems, like those with HIV, TB is what they most often die of.