K-One unit gets conditional approval extension to distribute Covid-19 test kit

KUALA LUMPUR (Aug 17): The Medical Device Authority (MDA) has granted K-One Technology Bhd's unit an extension of conditional approval to import and distribute the Covid-19 antigen self-test kit until Aug 14, 2027.

In a filing with Bursa Malaysia, the company said its unit, K-One MediTech Sdn Bhd, received the conditional approval from the MDA — an agency under the Ministry of Health — to distribute the test kit, manufactured by China’s Labnovation Technologies Inc in the country in October last year.

The conditional approval given then was valid for one year, from Oct 26, 2021 to Oct 26, 2022.

K-One said the extension of the validity period of the approval is in the best interest of the company.

“Covid-19 Antigen Self-Test Kits with MDA approvals are expected to be still in market demand, despite the world claiming endemicity, as Covid-19 lingers on with variants and sub-variants. The end of Covid-19 remains unclear,” it added.

K-One shares fell 0.1 sen at 11.5 sen on Wednesday (Aug 17), giving the group a market capitalisation of RM91.69 million.