Medical Device Authority (MDA)
FOR IMMEDIATE RELEASE
Medical Device Authority (MDA) Malaysia Approves and Recommends
Hotgen Novel Coronavirus 2019-nCoVAntigen Test (Colloidal Gold) Rapid Test Kit
Kuala Lumpur, Malaysia, 01 April 2021
Universal Therapeutics Sdn. Bhd. is pleased to announce that the Hotgen Novel Coronavirus 2019-nCoVAntigen Test (Colloidal Gold) (“Hotgen Antigen Test”) has been approved and recommended for use by the Medical Device Authority of the Malaysia Ministry of Health (“MDA”).
The Hotgen Antigen Test was developed by Beijing Hotgen Biotech Co., Ltd. and boasts a market-leading sensitivity, specificity and accuracy rating of 96.30%, 99.13% and 97.76% respectively. The test detects the presence of viral proteins in acute or early Covid-19 infection by analyzing secretion samples collected using nasal or throat swabs.
“The decision by the MDA to approve and recommend the Hotgen Antigen Test for use in Malaysia paves the way for us to contribute in the fight against the Covid-19 virus and to help Malaysians go about their daily lives safely”, said Chief Executive Officer, Mr. Sidney Soares.
The Hotgen Antigen Test is also approved and used in the United Kingdom- The Medicines and Healthcare products Regulatory Agency and Germany- Federal Ministry of Health (Bundesministerium für Gesundheit, BMG).
Following the positive development on the Hotgen Antigen Test, Universal Therapeutics is working towards the registration of Covid-19 vaccines in Malaysia.
For further information on the Hotgen Antigen Test, you may visit our website at
https://universal-therapeutics.com/ or contact groupsales@universal-therapeutics.com
For MDA’s Approval and Recommendation, visit
https://portal.mda.gov.my/announcement/596-list-of-recommended-for-use-of-covid-19-ivd-test-kit.html
About Universal Therapeutics:
Universal Therapeutics is a multinational pharmaceutical and biotech company based in Kuala Lumpur, Malaysia. The company’s businesses include manufacturing, distribution and white label production of pharmaceutical products, medical supplies, and PPEs in Asia and throughout the world.
Universal Therapeutics distribute nitrile gloves; three-ply face masks; KN95 and N95 masks; “HotGen Covid-19 RNA PCR” tests and “HotGen Novel Corona virus 2019-nCoV Antigen (Colloidal Gold) – 15 Minutes Rapid” tests to wholesalers, medical institutions, and government organisations. Their products comply with World Health Organization (WHO) guidelines and are accredited and approved by various health ministries as safe for human use.
For more information:
Samuel David CHAI
Chief Commercial Officer
Office: +60 3 9213 0318
Email: GroupPR@Universal-Therapeutics.com
Website: www.Universal-Therapeutics.com