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MALAYSIAN COMPANY, MEDICAL INNOVATION VENTURES DEVELOPS TEST KIT FOR COVID-19
Wednesday 18/03/2020
PENANG, Malaysia, March 18 (Bernama) -- Malaysian company, Medical Innovation Ventures Sdn. Bhd. (Mediven®), a company in MTDC's ecosystem has developed two new laboratory test kits for use in testing patient specimens for COVID-19, including influenza and influenza-like illnesses, and for confirming COVID-19, respectively.
The single-tube assay, GenoAmp® Real-Time RT-PCR Flu A/ Flu B/ SARS-CoV-2/MERS-CoV, can detect and differentiate influenza A (H1N1, H3N2), influenza B, SARS-CoV-2 (Nucleocapsid, N gene; RNA-dependent RNA polymerase, RdRP gene; and Spike, S gene) and MERS-CoV simultaneously from a single drop of patient specimen. Due to the nature of these closely related diseases, it is often difficult to differentiate physical symptoms of one disease from another. Symptoms may include fever, cough and shortness of breath.
The other single-tube assay, GenoAmp® Real-Time RT-PCR SARS-CoV-2 can confirm the COVID-19 infection by screening the RdRp and S genes, and confirming by using N gene.
These assays have been designed based on the international recommended protocols posted by World Health Organization (WHO) for COVID-19 diagnosis. A recent study published in Lancet on 24 January 2020 reported that S genes have better sensitivity to pick up COVID-19 in nasopharyngeal swabs.
“The working principle of these tests is based on RT-PCR technology in which RNA molecules of the target viruses are converted into their complementary DNA (cDNA) sequences by reverse transcriptase, followed by the amplification of the newly synthesized cDNA by standard PCR procedures. RT-PCR is currently the procedure of choice in the detection and confirmation of COVID-19,” said Dr. Nicole Tang, the scientist behind the test.
These kits act as early screening tests which enable simultaneous testing in a single-tube as compared to the existing multi-tube assays available. This allows improvement of efficiency in workflow, maximising throughput and helps hospitals screen patients faster.
“Speed is of utmost importance in saving lives and curbing the spread of emerging infectious diseases such as COVID-19,” Mediven® Operations Director, Dr. Lim Li Sze said in a statement.
Dr Muhammad Nazri bin Aziz, Consultant Medical Microbiologist of Lablink (M) Sdn Bhd, who runs tests for KPJ Healthcare network of hospital, when contacted, commented on the kit. “Good strategy. A customized panel for Asia.”
“We aim to provide an accurate and efficient tool that healthcare professionals are able to add to their arsenal in the battle to control this spreading contagion”, Mediven® Executive Director, Ariff Ismail stated. About Medical Innovation Ventures
Medical Innovation Ventures Sdn. Bhd. (Mediven®) is a medical diagnostic company which develops, manufactures and markets advanced high quality clinical diagnostic molecular and rapid tests. With a vision to be a leading provider of personalised health through innovative diagnostics, Mediven® provides solutions for screening of a variety of infectious diseases including dengue, chikungunya, zika, malaria, influenza, tuberculosis and many more.
Being scientists at heart, Research and Development is paramount within Mediven® as it allows us to continuously improve the standard of our diagnostic offerings, ensuring our products remain technologically competitive in the industry. Coupled with knowledge from experts who have worked on different disease areas for decades, Mediven® strives to provide innovative solutions to aid in difficult diagnosis of diseases for better healthcare and disease management.
Located in South East Asia, Mediven® is proud to be one of the few companies in the region developing its tests in its own laboratory, manufacturing the products in-house and delivering the products through its own sales team. Currently, Mediven® products can be found in all government and private hospitals and laboratories in Malaysia. Internationally, Mediven® has begun to penetrate ten countries in Asia and South America.
The characteristic features of Mediven®’s proprietary products are Fast, Flexible, Intelligent and Reliable. Our meticulous research throughout the years has enabled us to consistently develop assays which are of high quality in terms of accuracy and reliability. Our dedication is acknowledged by the BioNexus status awarded to the company by the BioEconomy Corporation, a government-linked agency in Malaysia, in recognition as an innovative research company. The company received accolades from Frost & Sullivan as Entrepreneurial Company of the Year award in the in vitro diagnostics category in 2017 and from Ernst & Young for the EY Entrepreneur of the Year™ 2018 award in the women’s category.
Our philosophy of quality is emphasized by our adherence to internationally recognised ISO13485:2016 standards. “CE” marking on our products demonstrate our conformity to EU safety, health or environmental requirements and legislation, and allows free movement of the product within European Economic Area (EEA). Mediven® has also been granted a medical device Establishment License by the Malaysian Medical Authority (MDA) to import, export or place any registered medical device in the market. Within Malaysia, the company has been awarded the Good Distribution Practice for Medical Devices mark for the quality, safety and performance of its medical device for all aspects of its supply chain.
For more information, please visit our website: www.mediven.com.my
SOURCE: Malaysian Technology Development Corporation (MTDC)
FOR MORE INFORMATION, PLEASE CONTACT: Name: Dr Lim Li Sze Tel: +604-656-2824 Email: admin@mediven.com.co
--BERNAMA
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