Medical Innovation Ventures Sdn Bhd (Mediven®) announced that both its real-time PCR kits for COVID-19 have been approved for sale in the European Union (EU). CE marking is a notification process to authorities which enables companies to market and sell products in the EU.
GenoAmp® Real-Time RT PCR Flu A/ Flu B/ SARS-CoV-2/ Mers-CoV kit is for the screening of influenza and influenza-like illnesses. The other kit GenoAmp® Real-Time RT PCR SARS-CoV-2 is for the confirmation of COVID-19, designed based on three genes recommended by the World Health Organisation (WHO) to increase sensitivity. A study published in Lancet on 24 January 2020 reported that spike genes have better sensitivity to pick up COVID-19 in nasopharyngeal swabs.
The Institute of Medical Research (IMR) has reported that GenoAmp® Real-Time RT PCR SARS-CoV-2 test results were consistent with the IMR’s tests and is in line with the World Health Organisation’s and United States Center for Disease Control’s (CDC) recommendations.
Operations Director Dr. Lim Li Sze said that the kit is premixed and ready to use, shortening the usual processing time from six hours to three hours. She stated that it is especially sensitive for swabs from the upper and lower respiratory tract as it uses the Spike (S) gene, in addition to the RNA-dependent RNA polymerase (RdRp) and Nucleocapsid (N) genes. The kit also contains Internal Control (IC) to eliminate PCR inhibitions and sampling problems.
Dr. Nicole Tang added, “The kit is specifically designed to target the conserved regions of these genes. By targeting 3 different genes, it increases the sensitivity of the test in detecting SARS-CoV-2 because should the virus mutate, the chances of all 3 targets mutating is low.” With this new CE-IVD marked product, Mediven® aims to play a global role in providing accurate diagnostics to curb COVID-19.
Mediven® is a developer and manufacturer of molecular and rapid tests with ISO13485 certified facilities based in Malaysia. The company was awarded the BioNexus status by the Malaysian BioEconomy (previously the Malaysian Biotechnology Corporation) in January 2015 for its technological innovations in the field of IVD. The company is also a company under the Malaysian Technology Development Corporation (MTDC) ecosystem.
Dato’ Norhalim Yunus, Chief Executive Officer MTDC mentioned “Mediven’s in-house scientists and collaborators have the capability to develop their own tests thus enabling them to differentiate their tests and collaborate closely with research institutions locally and abroad. Besides the European Union, internationally Mediven® has begun to penetrate ten countries in Asia and South America.
COVID-19 has given an opportunity for local technology companies like Mediven® to innovate and produce new medical technology to contain the growing pandemic. Our local talents will be an important factor in paving the platform for Industry 4.0 in Malaysia as we no longer will depend on imported technology to drive the economy.”