South African entrepreneurs to transform the COVID-19 testing process and clear the testing backlog.
Johannesburg, South Africa, June 10, 2020 – Biomax Genomics (Pty) Ltd today announced the newly developed CompleteMag ViralRNA kit. This kit is used as part of the international gold standard in COVID-19 testing, that involves RNA extraction from a swab, followed by PCR to confirm the presence of the virus.
A South African biotechnology company Biomax Genetics (Pty) Ltd, a partner of Biomax Genomics (Pty) Ltd, has completed development of a locally manufactured viral extraction kit. The CompleteMag Viral RNA extraction kit has been specially designed for SARS-CoV-2. The technology has been tested in multiple labs in South Africa and performed well relative to international competitors from the USA and Europe
It simplifies the isolation of viral RNA from nasal and throat swabs.
As a result of local manufacturing of these products, South Africa now has direct access to skilled scientists from the R and D team, thereby providing unprecedented local technical support to improve testing accuracy and speed.
Accuracy of the test kit was confirmed using previously positive samples for COVID-19 (SARS-CoV-2). The same samples tested positive using the CompleteMag Viral RNA Kit.
Furthermore “all samples that previously tested positive using a leading international kit, also tested positive using the Biomax Genetics chemistry, despite a 50% dilution of the sample before extraction” was quoted from official Lab Test Results. This highlights the sensitivity of the kit for SARS-CoV-2
The suite of diagnostic reagents test for the virus in the throat and nasal swabs, as well as other body fluids such as blood. The optimized reagents ensure that viral RNA is selectively bound to the superparamagnetic beads while impurities are efficiently removed during the quick wash steps. The rapid workflow gives pure and high-quality nucleic acids suitable for sensitive molecular testing, including quantitative polymerase chain reaction (qPCR, RT-qPCR) and next-generation sequencing (NGS).
Biomax Genetics launched in January 2016, after a 2-year research and development process the first for-sale kit was produced in March 2018, following a successful client test the first kit was sold in April 2018. Sales to date are in excess of 120 000 extractions in the research space. In late 2019 Biomax Genetics headhunted a leader in the field and the laboratory is now led by Dr Genevieve Thompson, Head of Research and Development, under her expertise the team has worked tirelessly to develop the groundbreaking kit for SARS-CoV-2 detection.
There are no other manufacturers of an equivalent product in Africa.
Biomax Genomics has been in talks with local authorities to receive approval to manufacture 1,000,000 kits per month, immediately resolving South Africa’s current and future testing backlog.
“We look forward to completing our SAHPRA registration and joining team South Africa on the fight against COVID-19 with our CompleteMag Viral RNA Kit”, said Head of Sales, Mhlangabezi Mbadamana.
The introduction of the kit will enable sustainable testing strategies and alleviate current shortages. The CompleteMag Viral RNA Kit is a proudly South African product!