Second-generation of AptameX, Achiko’s innovative DNA aptamer diagnostic test for Covid-19 has received full approval in Indonesia for five years
Production of the second-generation AptameX kits to commence this month
CE Mark filing is dependent on selecting a site to complete the clinical investigation report which is in the process of being secured
AptameX second-generation samples being sent elsewhere in Asia, MENA and eastern Europe for product sampling and demonstrations with the ambition of starting commercialization outside Indonesia as soon as possible
ZURICH, Switzerland, Dec. 08, 2021 (GLOBE NEWSWIRE) -- Achiko AG (SWX: ACHI, ISIN CH0522213468) through PT Achiko Medika Indonesia (“Achiko”, the “Company”) is pleased to announce that the Ministry of Health of the Republic of Indonesia has granted full product registration approval for its optimized, second-generation Covid-19 rapid test AptameX™, alongside its sister digital passporting service, Teman Sehat™ (“Health Buddy”).
AptameX: Second-Generation Product
In August 2021, Achiko’s manufacturing partner PT Indofarma TBK (“Indofarma”) received product registration approval in Indonesia for the Company’s first generation AptameX test kit. Following approval of the first-generation product, the Company further optimized the test kit using a simpler supply and manufacturing chain in Taiwan and Indonesia. This will allow Achiko to profitably produce its second-generation AptameX test kits for as little as USD$2.50 per test or less with a production capacity that is able to scale to tens of millions of kits per month as a function of commissioning capacity in plastics.
“As we have seen, vaccinations alone cannot be the only approach to living with Covid-19. Regular Covid-19 testing and screening should be an essential part of our lives as variants continue to hinder global recovery,” said Steven Goh, CEO of Achiko AG. “One of the basic conditions we have to create is giving people access to affordable and accurate rapid tests. This is key in all efforts aimed at mitigating transmission, particularly in areas with a large unvaccinated population. The five-year approval from Indonesia’s Ministry of Health provides Indonesia’s 270 million population with exactly that: access to an accurate Covid-19 diagnostic at an affordable price.”
The Company has completed initial production of its first-generation product and is currently commissioning the production capacity for its second-generation product with production to commence later this month. There is a temporary production constraint to secure custom molding for plastics to resolve and to finalize quality control of the initial first-generation production. The Company expects the issues to be resolved shortly.
“The Company has a reach to over 5% of Indonesia’s population as a result of the progress we’ve made with Teman Sehat, and as soon as we’re able to establish supply we look forward to being able to reach our goal at providing assurance services to communities and businesses in Indonesia," added Goh.
CE Mark and Internationalization
The company is making progress with its CE Mark and expects to have a declaration of conformity in Q1 2022. The two material items outstanding are the appointment of an original equipment manufacturer (OEM) partner and the completion of the clinical investigation report. The former is being secured shortly. For the clinical investigation report, a site to conduct the clinical investigation outside of Indonesia is in the process of being secured.
The Company has formally commenced discussions to start commercialization of its test kits in other parts of Asia, the Middle East and northern Africa (MENA), and eastern Europe. Samples of AptameX second-generation test kits are being shipped to these locations for product sampling and demonstrations to be held this month.
"The big advantage of AptameX is the difference in chemistry," said Goh. "Using aptamers instead of antigens results in a more cost-effective, sensitive test in a format that is both consumer-friendly and timely. In a world of rapid tests and PCR tests, AptameX can be positioned as an effective screener at the point of need and in turn help us live with Covid-19 and move on with our lives."
ABOUT ACHIKO AG
Achiko creates and develops new innovations in healthcare technology through its biotechnology division, AptameX™, and its sister digital mobile health technology division, Teman Sehat™. The Company has created a unique healthtech capability that provides user-friendly diagnostic testing integrated with a digital passport solution for the management of Covid-19.
AptameX comprises of DNA aptamer-based technology that is cost-effective, chemically synthesized and widely applicable to the evolving diagnostic field of healthcare. Together with the digital mobile health app Teman Sehat, Achiko is developing potential technologies that seek to deliver rapid, affordable diagnostic testing for a range of pathogenic diseases and therapeutic indications. The AptameX technology is licensed from Regenacellx.sl and Achiko has exclusive commercialization rights.
Headquartered in Zurich, Achiko has offices in Hong Kong, Jakarta, Seoul, and Singapore.
Further information can be found at www.achiko.com.
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This communication expressly or implicitly contains certain forward-looking statements concerning Achiko AG and its business. Such statements involve certain known and unknown risks, uncertainties, and other factors, which could cause the actual results, financial condition, performance, or achievements of Achiko AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Achiko AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.