Malaysia Permission Granted for COVID-19 Test Kit from China for Emergency Use; Homegrown Holista Colltech Receives Initial Order for 15,000 Units for Deployment
KUALA LUMPUR, Jun 18, 2021 - (ACN Newswire) - Amid rising concerns over the threat and economic impact of COVID-19, Holista Colltech Ltd ("Holista") has been granted permission for special access under the Medical Device (Exemption) Order 2016, 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. ("Hecin"), Guangdong, 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 (ASX: HCT), 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.
Antigen tests look for the coating or proteins of the virus while Polymerase Chain Reaction (PCR) tests detect its nucleic acid, or genetic material (also known as RNA). The former can deliver results within minutes and generally cost less; the latter, while more accurate, can take up to several days and are generally more expensive.
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 (US$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.
The clinical performance of the Hecin RTK-Antigen test kit using the PCR Comparator method with nasopharyngeal swab specimens obtained a sensitivity of 96.23% and specificity of 99.07%. The trial was carried out in Daye City Center for Disease Control and Prevention within China. The results serve as the basis for obtaining the CE mark in Europe. The MDA also conducted its own clinical trials in Malaysia prior to this approval.
The MDA also granted Holista similar import and distribution approval for Hecin Antibody Test kit which can test human serum, plasma or whole blood for levels of antibodies to assess immunity after vaccination.
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.
"The pandemic has impacted Malaysia severely with rising infections, deaths and prolonged movement controls which have disrupted business, education, social interaction and many other activities. Rapid testing is the key to controlling the spread of infection and revive economic activity with confidence," said Holista's CEO, Dato' Dr Rajen Manicka.
"An infected person can spread the virus for several days without showing symptoms. To counter this, regular antigen RTK testing can curb infections control in a very affordable manner. High-frequency mass testing has been hugely successful in curbing infections in China, South Korea, Slovakia, Switzerland and the United Kingdom. We are glad that they are being introduced in Malaysia," he said.
"The Slovakia approach of testing brought infections down by more than 50%. Its success has been reported by British Medical Journal, The Lancet, Science and Scientific American earlier this year," Dato' Dr Rajen added.
Holista has also developed a mobile application that allows efficient tracking and tracing based on the 'Traffic Light' model that has been successfully deployed by the National Health Service in the United Kingdom.
About Holista CollTech Ltd
Holista CollTech Ltd ("Holista") is a natural wellness company with the following divisions: - Infection Control Solutions - Dietary supplements - Food Ingredients - Ovine collagen
Holista has a global collaboration with Global Infection Control Consultants LLC to use Path-Away(R), a plant-based solution that is proven to kill a broad spectrum of microbes. The all-natural alcohol-free active ingredient is used in Holista's range of sanitising products under the NatShield(TM) brand.
Listed on the Australian Securities Exchange (ASX: HCT), Holista researches, develops, manufactures and markets health style products. Holista's suite of ingredients includes low GI baked products, reduced-sodium salts, low-fat fried foods and low-calorie sugar without compromising taste, odour and mouthfeel. Holista also produces sheep (ovine) collagen using patented extraction methods. For more information, please visit www.holistaco.com.
Media Contact: WeR1 Consultants Pte Ltd E: holista@wer1.net M: +65 6721 7161
Source: Holista CollTech Ltd Sectors: BioTech, Healthcare & Pharm
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
Latest Press Release
JCB enables JCB Contactless acceptance at Taichung MRT in Taiwan Apr 26, 2024 10:00 JST
| Mazda Production and Sales Results for March 2024 and for April 2023 through March 2024 Apr 25, 2024 18:21 JST
| MHI Begins Operation of SOEC Test Module the Next-Generation High-Efficiency Hydrogen Production Technology at Takasago Hydrogen Park Apr 25, 2024 17:45 JST
| GAC Honda to Begin Sales of All-new e:NP2, the Second Model of e:N Series Apr 25, 2024 16:50 JST
| Toyota Exhibiting at Beijing Motor Show 2024 Apr 25, 2024 16:25 JST
| Honda Reaches Basic Agreement with Asahi Kasei on Collaboration for Production of Battery Separators for Automotive Batteries in Canada Apr 25, 2024 11:10 JST
| UNIQLO Sponsors KAWS + Warhol Exhibition Tour, Starting in Pittsburgh Apr 25, 2024 09:00 JST
| Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date Apr 24, 2024 17:19 JST
| MC and Denka Sign J/V Agreement in Fullerene Business Apr 24, 2024 17:02 JST
| Mitsubishi Motors Posts Record Sales in the Philippines in FY2023 Apr 24, 2024 13:56 JST
| NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance Apr 24, 2024 13:25 JST
| Fujitsu SX Survey reveals key success factors for sustainability Apr 23, 2024 10:25 JST
| Fujitsu and METRON collaborate to drive ESG success: slashing energy costs, boosting productivity with new manufacturing industry solutions Apr 22, 2024 16:09 JST
| NEC Strengthens Commitment to Space Industry with Investment in Seraphim Space Venture Fund II Apr 22, 2024 15:09 JST
| Soft Space Launches the First and Only JCB Payment Gateway in Malaysia Apr 22, 2024 15:00 JST
| TOYOTA GAZOO Racing takes a one-two in Croatian thriller Apr 22, 2024 10:47 JST
| First-ever Mazda CX-80 Crossover SUV Unveiled in Europe Apr 19, 2024 13:50 JST
| Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces Apr 19, 2024 10:17 JST
| Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas Apr 18, 2024 17:01 JST
| Toyota Launches All-New Land Cruiser "250" Series in Japan Apr 18, 2024 13:39 JST
|
More Latest Release >>
|