Showcasing a globally successful university enterprise that changed mass testing for TB and CoViD-19

The global success story of a TB diagnostic that emerged from a Johannesburg laboratory and made medical history mesmerised delegates at the 6th annual Entrepreneurship Development in Higher Education (EDHE) Lekgotla 2022. Today, that same laboratory supports TB testing programmes in 51 countries around the world.

As importantly, the technology has been able to pivot to deal with the CoViD-19 virus, making for easier, quicker critical testing during the pandemic and supporting 34 countries for coronavirus testing.

“In order for this to happen, a speciman has to be collected and make it to the laboratory to be tested. You eventually get your result through some electronic system. But, how do we believe laboratory results?”

Laboratories, he said, work through two systems, the first of which requires:

• that instruments and staff working in the lab are fit for purpose
• those specimens are handled appropriately, allowing good workflow to prevent specimens mix-up
• accurate execution of the diagnostic test – people must know what they are doing
• The diagnostic test to work; and that
• Results are captured correctly.

“All of this falls under the blanket term proficiency testing,” Professor Kana said.

The second crucial factor, he said, was determining whether new tests were fit for purpose. “This became relevant in the context of CoViD-19 where new tests were entering the market daily.” Proficiency testing needed a controlled specimen, with a known amount of a disease-causing agent – but the infectious specimens were difficult to transport and dangerous.

Here is how his team’s problem was framed: the need for biologically safe controlled material. He explained: “The context goes back a decade when South Africa made a policy decision to roll out molecular diagnostics for TB – so PCR-based diagnostics for TB. “The plan was to roll this out at all microscopy level centres around the country. A large number of the labs were going to get a molecular diagnostic device. They needed to calibrate that device and they needed biologically safe controls.

“We couldn’t send live TB bacteria to labs because we’d make people sick. This became a significant barrier to rolling out new diagnostics.” The genius solution Professor Kana’s team came up with was bio mimicry – the mimicking of live systems.

His team investigated ways to mimic these dangerous bacteria in a way that the laboratories could use controls in a safe and sustainable manner. Molecular diagnostics work in a way that the device detects the DNA of TB bacteria.
“We reasoned that if all that is detected is DNA, we could kill the bacteria without damaging the DNA and the molecular diagnostic device would not know any difference.

“Our first series of products was dead bacteria. We grew bacteria in our laboratory, we killed them and then we deployed them to labs as controls. “There was a lot of uptake. But these bacteria were hard to grow – it takes between 4-6 weeks to grow a culture of TB – and they were dangerous. It was an expensive exercise, limiting in cash-strapped health systems.”

In exploring ways to simplify the process, Professor Kana’s researchers found harmless bacteria living in the sand, that look like TB, are cheap, grow quickly and are not dangerous. Using a simple gene transfer technique, they moved the DNA into these harmless bacteria which effectively allowed them to mimic dangerous TB bacteria in molecular diagnostics.

To deploy the controls, they killed the bacteria, put them onto a little dried spot with a barcode, sent that to all the labs in the country. Professor Kana said: “Remember, they didn’t know the result, only we did. They ran the test using cloud based software, fed the results to our algorithm and we knew whether they’ve done the test correctly or not. If they did, we flagged them green to say go ahead.”

The benefit, the audience heard, was huge. There was a massive reduction in cost; it became scalable; these labs could go online and they could test. “We thought it was quite an interesting innovative way of handling a problem that was being faced by society; the university spun out a company to market the products; SmartSpot Quality.

“Initially we validated all the labs within our Johannesburg area. Within eight months, we had done all the provinces.

“Subsequent to that, our product received World Health Organisation (WHO) and Centre for Disease Control (CDC) endorsement, and over two years we had requests from all over Africa and the world to supply them with the product.

“Today, from our laboratory, we support 51 countries for the TB testing programmes – either through laboratory networks or though their national priority programmes.

At the outbreak of the pandemic, Professor Kana and his team received a government request to help with routine CoViD-19 testing. They were told that there numerous CoViD tests on the market but it was unknown if they were viable.

“South Africa didn’t have enough diagnostics or controls. PCR CoViD testing involves extracting the genetic material of the virus (kept as RNA), converting that to DNA which is then detected by PCR tests. “The health system was stuck and mass testing could not start.”

His research team went back to the soil-dwelling bacteria, took those bits of the coronavirus genome that get detected by the diagnostic test and engineered them into these bacteria creating the world’s first bacterial corona virus biomemetic. Immediately, a health system problem was solved, and testing could begin.

Professor Kana says the real success of his endearvours was the biomimicry platform technology that could pivot depending on the disease at hand.

Reflecting over his research journey:

1. Working for something you do not care about is stressful. Do not confuse that with passion. Don’t find reasons not to do something. Things are hard and we’re all resource-constrained, but you are not defined by your resources. When I moved in my lab the ceiling had fallen in, the plumbing was leaking, the electricity was a problem… we cleaned up and from it were able to reach out all over the world and create some impact. You are defined by the quality of your thinking and the reach of your imagination.
2. Learn to listen. I like to say: learn to speak last.
3. Be accountable – for your successes and your failures. I stand before you as the sum total of all my failures. It’s only on the basis of this that we have been able to build any measure of success. I say fail gloriously, go down in flames and rise again.
4. Be humble. The entrepreneurial journey will humble you because you’ll fail all the time. Humility is an important contributor to success. Money and fame will come and go. You need to remember why you came into the game – stay on mission. Wear the mantle of humility, not with shame, but with dignity that befits the goals you’re trying to pursue.
5. What has been satisfying for us, as a team is the ability to create products, to take our research and translate it into something meaningful has allowed us to create meaning from our work.

Being in a supportive environment is incredibly important for both student and academic entrepreneurs. But what does supporting entrepreneurs mean? We had to go out and find our own funding. Working in a space where innovation is valued is important. People feel they are contributing to something that is part of the broader mission of the university.

Charmain Naidoo is a contract writer for Universities South Africa