ADT Biotech Sdn Bhd, a producer of ISO 13485-certified IVD test kits and a BioNexus-status company under the Malaysian Bioeconomy Development Corporation (Bioeconomy Corporation), has received regulatory approval from India for its LyteStar 2019-nCoV RT-PCR test kits.
ADT Biotech managing director Dr Finn Zedler attributed the success to the various forms of support and assistance provided by Bioeconomy Corporation, specifically in the involvement of various parties in the marketing of of the LyteStar 2019-nCoV RT-PCR kits and other ADT products in Malaysia and the region.
"We are satisfied that the quality of our products is recognised and we are committed to giving the best value to our customers and partners in the region,” he said in a statement today.
He said India has also given ADT India, a subsidiary of ADT Malaysia Biotech, an import licence for the LyteStar 2019-nCoV RT-PCR and LyteStar SARS-CoV-2 RT-PCR S test kits after they were validated by the Indian Council of Medical Research (ICMR), Central Drugs Standard Control Organisation (CDSCO) under the Directorate-General of Health Services, Ministry of Health and Family Welfare, India.
The test kits have since been in the IMCR list of validated and approved detection kits of SARS-CoV-2 RNA by Real Time PCR, he said.
Zedler said the Ministry of Health Malaysia had awarded ADT Biotech to supply its LyteStar 2019-nCoV RT-PCR kits to all centres under the ministry’s jurisdiction authorised to test for the SARS-CoV-2, the virus that causes the Covid-19.
"Preceding the award, the LyteStar 2019-nCoV RT-PCR kit had been validated by the Institute of Medical Research (IMR) with concomitant results against IMR’s reference test," he said.
Meanwhile, Bioeconomy Corporation acting CEO Mohd Khairul Fidzal Abdul Razak said the LyteStar 2019-nCoV RT-PCR kit has received approval not only in Malaysia but also in India, showing international recognition of the product in the diagnosis of Covid-19 patients.
"Bioeconomy Corporation will continue to support ADT Biotech and other BioNexus-status companies involved in developing products and services that benefit the local and global communities, in line with the 'Going Global' mandate under the third phase of the National Biotechnology Policy (NBP) in Malaysia," he said.
With ADT’s less complicated testing procedure, more cases can be tested and only those who tested positive will be retested. The kits are routinely used in Malaysia, Thailand and Pakistan, and have been sent to India, Korea, Sri Lanka and Iran. -- April 20, 2020,