CAPE TOWN - A Cape Town based biotechnologist is beaming with pride as South African Health Products Regulatory Authority (SAHPRA) approved his company’s Covid-19 antigen testing kit.
Ashley Uys, 39, from Belhar and founder of Medical Diagnostech, has welcomed the approval from SAHPRA after 18 months of working on the antigen testing.
Medical Diagnostech (Pty) Ltd was established in 2010 as a developer and manufacturer of lateral flow rapid diagnostic test kits.
This will be the first Covid-19 testing kit coming from Africa.
Speaking to IOL on Wednesday, Uys said the nasal swab test provides results within 15 minutes.
He said the test, which will cost $3 (between R30 to R35) is set to save Africa money.
“We really do welcome the approval of the testing kit. It has been a tedious process as we first had to get ethical clearance to conduct clinical trials. Then we had to conduct the clinical trials and then await approval from national.
“We will now be the first African manufacturers of this antigen test, everything else in the market currently is not from Africa,” Uys said.
He said credit should go to the 10-man team of six scientists and four technicians (including himself) who have worked hard on this project.
“We have African solutions for African problems.
“I am going to release this technology throughout Africa, so manufacturers can have this technology so Africa can save money,” Uys told IOL.
He said the testing will be run via the national government.
Uys said they have also developed home testing kits, with those being tested only needing to swab the front of their noses. However, he said they are still awaiting approval from the government to make this home test kit available to all.
Dr Michelle Mulder, Executive Director for Grants Innovation and Product Development at the South African Medical Research Council (SAMRC) welcomed the announcement.
“This investment from the SAMRC, the Department of Science and Innovation (DSI) and the Technology Innovation Agency (TIA) has enabled the final product development steps required to deliver an approved antigen detection test for COVID-19 that meets the minimum globally accepted performance criteria for such tests.
"The local ownership and manufacture of these test kits will not only increase South Africa's self-sufficiency in a time of high demand, but also contribute to reducing the trade imbalance with respect to medical devices and local economic development and job creation,” Mulder said.
DIS Director-General, Dr Phil Mjwara said the latest development further expanded South Africa's ability to respond to Covid-19.
“Not only has the DSI supported the development of a capability to locally produce the reagents for PCR tests by start-up company CapeBio, but the Department, together with the SAMRC, believed that with the necessary funding it was possible to locally develop rapid tests for the detection of active Covid-19,” he said.
Mjwara said the vision and investment had paid off with Medical Diagnostech’s Covid-19 antigen test, which lowers the cost of testing active infections.
"This technology not only benefits the country, but will also be made available to the rest of Africa," Mjwara said.
TIA’s head of health programme, Osmond Muroyiwa said the organisation was living by its mantra that innovation must answer the challenges of the day.
“We are living in a moment where science has to provide answers in tracking an invisible enemy that has ravaged societies and economies globally.
"The ability to produce test kits locally is testimony to the great scientists and innovators we have, who with the right support can help save lives, reduce imports, create jobs, and ultimately improve the quality of life of all South Africans," Muroyiwa concluded.