Wednesday, 24 April 2024

Malaysia grants permission to COVID-19 test kit from China

19 June 2021 | News

Local firm Holista Colltech secures an initial order for 15,000 units in Malaysia

Photo Credit: Freepik

Photo Credit: Freepik

Holista Colltech Ltd has been granted permission from the Medical Devices Authority (MDA) of Malaysia's Ministry of Health (MOH) to import and distribute the antigen rapid test kit (RTK-AG) developed and manufactured by Hecin Scientific Inc. in China. With this approval, the Company has secured an initial order for 15,000 units in Malaysia.

Holista, a natural wellness and health products specialist headquartered in Petaling Jaya and listed on the Australian Securities Exchange, said the Hecin(TM) 2019-nCOV diagnostic test kits can be used to detect the presence of the SARS-CoV-2 viral antigen from nasal swabs within 15 minutes.

The 15,000 units will be shipped by the end of this month to Klinik Mutiara, part of Amegajaya Sdn Bhd, a medical consultancy that works closely with MOH and related organizations. The maiden order secured by Holista's wholly-owned Holista Biotech Sdn. Bhd. is worth approximately A$95,000 ($73,000). The kits will be used by registered professionals at Klinik Mutiara for screening purposes.

MOH's Medical Devices Authority (MDA) has granted Holista permission to import and distribute up to 45,000 units of the Hecin antigen test kit for emergency use within three months from the date of approval on 14th June 2021.

Holista has the rights to distribute the Hecin COVID-19 test kits in Brunei, Thailand, Indonesia, Philippines, Taiwan, Vietnam, Cambodia, Laos, Myanmar, Singapore and the United Kingdom. The channel distribution will be handled by Holista's long-time partner, Zuellig Pharma.

Holista will build upon the approvals and commercial arrangements for these test kits to extend distribution rights and partnerships worldwide for pandemic-related infection control, testing and related healthcare solutions.

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