Sunday, July 25, 2021
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HomeWorldMalaysia Permission Granted For COVID-19 Test Kit From China For Emergency Use

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

2021 – (ACN Newswire) – Amid rising concerns about the
threat and economic impact of COVID-19, Holista Colltech
Limited 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 for an antigen rapid test
kit (RTK-AG) developed and manufactured by Guangdong Hecin
Scientific Inc. (“Hecin”) of China. With this approval, the
Company has secured an initial order for 15,000 units in

Holista Colltech Limited (“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 will 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

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

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

The clinical performance of Hecin RTK-Antigen
test kit against PCR Comparator method using nasopharyngeal
swabs specimens has obtained a sensitivity of 96.23% and
specificity 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 has 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 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.

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

“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

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

About Holista CollTech Limited

CollTech Ltd (“Holista”) is a natural wellness company with
the following divisions:
– Infection Control
– Dietary supplements
– Food
– 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)

Listed on the Australian Securities Exchange
(“ASX”), 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 on Holista, please visit

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