The Department of Science and Innovation (DSI), the South African Medical Research Council (SAMRC) and the Technology Innovation Agency (TIA), a DSI entity made seven funding awards to local companies, organisations and researchers in order to ramp up the country's ability to produce locally developed reagents and test kits for COVID-19.
The awards are valued at about R18 million with the funding recipients set to commence with their responsibility immediately with approximately six months to begin production.
"South Africa currently sources these reagents from international companies, but increasing global demand, fluctuating exchange rates and limited transport options are affecting the supply - resulting in an urgent need to source these components locally," said Minister Nzimande.
The Minister said there is an equally urgent need to strengthen South Africa's capacity for identifying active cases of COVID-19, to allow for more effective contact tracing and quarantining.
"To do this, the country needs to reduce the turnaround time for diagnosing active COVID-19 infections by developing point-of-care (PoC) kits for rapid, direct detection of the coronavirus," the Minister emphasised.
In response to the DSI, SAMRC and TIA call for funding proposals, eight proposals were received for the development of diagnostic reagents, while 24 proposals were received for the development of PoC rapid detection kits.
Following rigorous reviews by two panels, three funding awards were made in the first category, and four awards were made in the second category.
"These awards for local innovations will address bottlenecks in South Africa's COVID-19 testing, through the development of reagents that can be locally manufactured for existing gold standard COVID-19 tests, as well as alternative, point-of-care (PoC) diagnostic kits that can rapidly detect the presence of SARS-Cov-2 viral proteins and/or particles," said Minister Nzimande.
The awards come as the SARC-CoV-2 virus strengthens its grip in South Africa. The government has intensified a range of measures to contain the spread of the virus, and testing remains a critical part of this.
To date, more than 1,5 million tests have been conducted by the National Health Laboratory Service (NHLS) and private pathology labs using the current gold standard for testing, which is done on viral genetic material taken from nose and throat swabs.
The number of tests conducted per day has increased steadily since the start of the pandemic in South Africa, and is expected to rise further still, leading to substantially increased demand for reverse transcription polymerase chain reaction (RT-PCR) reagents.
Development of diagnostic reagents
The first award for the development of diagnostic reagents went to the Council for Scientific Research (CSIR), also an entity of the DSI. Under the leadership of Dr Previn Naicker, the CSIR will expedite the local manufacture of viral nucleic acid isolation kits for nasal and oropharyngeal swab samples. The CSIR will work closely with a number of spin-off companies on this project.
The second award went to the CSIR and CapeBio Technologies (Pty) Ltd for the development of application-ready RT-PCR reagents for COVID-19.
This project will be led by Dr Lusisizwe Kwezi from the CSIR and Dr Daniel Ndima from CapeBio. Under the leadership Dr Kwezi, the CSIR previously developed a cost-effective, commercial-scale technology for the production of Taq DNA polymerase, a key ingredient in RT-PCR reagents. This technology was licensed to CapeBio, which successfully commercialised it for local and international markets.
The Biopharming Research Unit (BRU) at the University of Cape Town, under the leadership of Prof. Ed Rybicki, received the third award in this category. The BRU will develop and produce highly stable synthetic DNA and RNA molecules containing all of the commonly used target sequences used for SARS-CoV-2 nucleic acid detection, as well as internal control sequences to check for the integrity of the nucleic acids.
The combination of these three projects would adequately address South Africa's immediate needs for locally produced RT-PCR reagents for gold standard test kits. The planned use of biopharming technologies, which involves the production of pharmaceutical proteins in plants that have been genetically modified for this purpose to produce these reagents will also an added advantage.
Minister Nzimande is pleased that these three projects brought together various science and innovation resources that existed as a result of investments that the Department of Science and Innovation made over the past two-and-a-half decades.
"The projects would also make good use of the strengths of the CSIR and several spin-off SMMEs, and showcase the excellence of a number of the country's young black scientists," said the Minister.
Development of rapid detection kits
Four projects will be supported for the development of PoC rapid diagnostic kits. This category focuses on rapid detection of the presence of SARS-CoV-2 viral proteins and/or particles, and excludes antibody tests. Rapid detection offers a number of advantages over the RT-PCR diagnostic method, as these tests can be administered on the spot and the results can be read within as little as 15 minutes.
Minister Nzimande said that the first award under this category went to Medical Diagnostech (Pty) Ltd, a company that has been developing and manufacturing rapid diagnostic tests for more than 10 years, including test kits for HIV (NICD approved), malaria (WHO approved) and Schistosoma (FDA approved).
"Under the leadership of Ashley Uys, the company has already begun developing an antigen-based rapid test for detecting acute cases of COVID-19. The test is designed to directly detect the COVID-19 spike glycoprotein S1 in saliva to determine whether a patient currently has an acute infection. It does not require trained lab staff or expensive machinery and is thus significantly more cost-effective than gold standard testing, and production can be scaled up to 100 000 units per day at the company's premises in Brackenfell, Cape Town," confirmed the Minister.
Mintek received the second award in this category, for the development of a rapid test kit for detecting the SARS-CoV-2 viral antigen in PoC or near-patient settings. Dr Amanda Skepu will lead the project, which will see Mintek partnering with other South African institutions and biotech companies.
"The third project will build on previous research on HIV that introduced aptamers as a more reliable detection molecule compared to antibodies. This work has been patented in South Africa and several other countries," said Minister Nzimande.
The Minister further said that the intellectual property currently held by the University of the Western Cape will be licensed to Diagnostic Aptamer Technologies-Aminotek (DATA), a commercial-ready test kit will be produced by DATA's research and development partner Amasu Technologies, and full-scale production will be undertaken by Medical Diagnostech (Pty) Ltd.
Minister Nzimande emphasised that the project will leverage an in-house developed algorithm, as well as the expertise gained on HIV, to identify several aptamers against any target, viral or bacterial protein.
The Minister said that with the SARS-CoV-2 genomic sequence having recently been published, it is expected that the design of aptamers specific to SARS-CoV-2 will enable its detection in a more sensitive, accurate and cost-effective way.
The final award in this category went to Gknowmix (Pty) Ltd. The company has been designing a loop-mediated isothermal amplification (LAMP) rapid test for COVID-19 that will be able to run on both open RT-PCR platforms (as used by the NHLS and private pathology labs) and the closed ParaDNA PoC platform for rapid testing.