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Health innovation is a multi-disciplinary effort

From a research project in the University of the Witwatersrand’s (WITS) laboratories to a growing business that has won a special award for social impact, SmartSpot is a testimony to the power of collaboration and the meeting of academic, scientific and entrepreneurial minds.

Nine years since SmartSpot’s first product – a response to a need for independent verification of the accuracy of new, ‘game changing’, molecular diagnostic tests for TB – was first conceived, the company has developed a global footprint in 29 countries and is responsible for Quality Control on 590 instruments around the world. Additionally, SmartSpot’s controls are distributed with all new GeneXpert molecular diagnostic instruments to 40 High Burden disease countries, to be used to assure the accuracy of the instrument on first use. SmartSpot now employs full time staff, boasts an order book of more quality control panels distributed in its second year of operation, than all previous years combined, even when Wits provided panels directly to sites, and is diversifying its product offering.

“Successful innovation is often a multi-disciplinary effort. In SmartSpot’s case, it spanned molecular diagnostics; in depth knowledge of TB organisms; engineering; expertise in the development of new technology-based products; as well as operational, entrepreneurial and commercial nouse”, says Ela Romanowska, Director of Innovation Support at Wits Commercial Enterprise.

“To create a technology and spin it out as a successful company also requires funding, contract support, legal and intellectual property expertise, as well as efficient transfer of know-how from the researchers to the business team. What makes SmartSpot’s story so inspiring is that the team initially did not set out to create a business. However, once they realiSed the potential and that they could not scale-up operations within their research group, they embraced the journey of entrepreneurship despite the fact that they themselves did not intend to run the company. It was a great privilege to work with these passionate researchers, willing to go beyond their comfort zones in order to create a great social impact success story.”

SmartSpot was born in 2010 out of the efforts of Professor Lesley Scott at WITS’ Department of Molecular Medicine and Haematology (DMMH) and Professor Bavesh Kana at the Centre for Biomedical TB Research (CBTBR), in response to a gap identified by Professor Wendy Stevens (Head of DMMH as well as the National Priority Programme). This gap was the need to find a way to independently verify the accuracy of the new molecular diagnostic tests for TB.

Before this new test, diagnosis required several weeks of culturing of a sputum sample, whereas the new molecular diagnostic testing could yield a result in only two hours. This meant that patients didn’t have to wait for the result back home in their communities, where they risked spreading the disease for several weeks.

WITS, the National Health Laboratory Service, and government partnered to raise local and international donor funds for the rollout of the new molecular diagnostic equipment to more than 200 testing laboratories across South Africa. However, to ensure a high level of confidence to justify the investment of many millions of Rands, independent verification of the accuracy of the equipment was necessary for assuring the success of the TB testing programme. At the time, no such verification existed.

Professor Lesley Scott at WITS’ Department of Molecular Medicine and Haematology (DMMH)

Profs. Scott and Kana rose to the challenge and developed a method for determining the amount of TB material in a so-called “dry culture spot” – a small sample of inactivated (i.e. killed) TB bacteria produced by the CBTBR. The dry culture spot – also called the DCS– could be dissolved off the card and placed into the diagnostic module just like a sputum sample. The result is uploaded to an independent auditing system via the TBGxMonitor website, where the accuracy of modules could be determined.

With the success of the verification testing during the rollout of the new TB diagnostics equipment in South Africa, public health programmes in other countries showed interest in the DCS for their rollouts. The unique formulation of the DCS is stable at room temperature for 24 months and the TB bacteria are inactivated so that the DCS is non-infectious. These two factors enable expedited shipping and low cost handling, which makes the specimens especially useful for emerging markets, where there are logistical and cold-chain challenges. Prof. Kana produced more inactivated TB stock, and Prof. Scott made thousands of DCS cards which were exported to several countries. Without these committed researchers fully realising it at the time, a business was being born!

As requests for more DCS cards increased, Prof. Scott took the lead in defining a strategy going forward. Together with the Innovation Support capability of WITS, located at Wits Enterprise, she entered the 2014 GAP BioScience and proceeded to win the competition, along with R500 000 in funding. Whilst on a roll, she also entered the Innovation Prize for Africa competition, and was awarded the Social Impact prize of R300 000. These funds were used by the team to seed the operationalisation of SmartSpot Quality (Pty) Ltd.

The time was clearly right to spin out the company. WITS Enterprise introduced Profs. Scott and Kana to Dean Sher, a young WITS Alumnus Biomedical Engineer, and budding entrepreneur. He had previously founded VeinAid (Pty) Ltd based on his 4th year research project, and was ready for a new challenge. He was looking to apply the learning gained from VeinAID into a new start-up. The Profs, Dean and Wits Enterprise worked together on the operational plan, and SmartSpot Quality (Pty) Ltd began trading in January 2016, when Sher was appointed as its Managing Director.

Sher says: “The company has been successful due to the ongoing commitment of Profs. Scott and Kana and their teams.”

Sher’s efforts to systematise and automate production, expand the TBGxMonitor result verification system to allow for real time external quality assessment (EQA)reporting, and fine tune procedures to a next level of sophistication, were a further necessary ingredient in the process to commercialise the technology. He was guided and supported actively by Wits Enterprise in a ‘virtual’ incubation form. The resulting multi-disciplinary team approach of researchers, entrepreneur and commercial support, was one of the critical success factors that has enabled SmartSpot to retain and grow the customer base to even more public health programme sites.

Through increasing the number of TB testing sites it reaches, SmartSpot assures the accuracy of the molecular diagnostic testing of an ever-increasing number of patients. In South Africa, SmartSpot has been used on all 282 instruments in the National TB Screening Programme. Over the duration of a year, SmartSpot costs less than 0.3% of the cost of the South African National TB Screening Programme and can save thousands of patients undergoing incorrect diagnosis.

To emphasise this point, during the roll-out in South Africa, the results of the qualification testing found that 2.6% of the instrument required additional servicing before being used for patient specimen testing. If the DCS had not been used, this could have translated to 78,000 test results of the 3-million tests performed, being incorrect. The harsh impact of this could have been that some patients may have remained undiagnosed and either have died, or spread the disease. Others could have been incorrectly diagnosed with TB and would have fruitlessly endured 18 months of drugs with major side effects, which can even lead to hearing loss.

“Apart from the very positive impact to thousands of TB patients, the global impact of the product we developed was that public health programmes, especially in developing countries with a high TB disease burden, were able to introduce the game changing molecular diagnostic equipment in their testing programmes, because the quality of the testing can be assured independently,” says Prof Scott.

SmartSpot is now working with Prof. Scott and her team to develop additional products for diagnostic testing verification of other pathogens. In the meantime, Prof. Kana has been working on methods to reduce the costs of producing the inoculated TB using bio-mimicry – the modification of non pathogenic bacteria to mimic the genetic code of TB, using seed funding secured through Wits Enterprise, as well as research grants. Sher is already thinking about how this could provide competitive advantage, or new product lines within SmartSpot’s suite of offerings.

“SmartSpot’s impact is both positive and far reaching for society, given the prevalence of TB and the need to qualify the accuracy of testing done through screening programmes. This impact is certain to grow as SmartSpot works to develop additional products for the independent quality assurance of molecular diagnostic testing. We are excited to continue walking this path from innovation to commercialisation with the team,” concludes Romanowska.

https://www.wits.ac.za

sibongile.horo@wits.ac.za

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