- Registered AptameX and has obtained a CE Mark, allowing the product to be sold in 27 countries in the EU
- AptameX has unique performance advantages over other rapid tests through its use of DNA aptamers
- The Company expects to have AptameX in widespread commercial availability in Q3 2022
Zurich, May 17 2022: Ad hoc announcement pursuant to Art. 53 LR – Achiko AG(SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, the “Company”) is pleased to announce that it has successfully registered AptameX™ under the European Union’s Medical Device Research (MDR) and In Vitro Diagnostic Regulation (IVDR), and has obtained a CE Mark that grants it access to 27 countries in the European Union for its Covid-19 AptameX test and system, establishing a foundation for applying for regulatory approval across the world.
“This is the first major mainstream use of DNA aptamers in a consumer testing product and a fantastic milestone for Achiko”, stated Steven Goh, CEO of Achiko AG.
Unlike other rapid testing formats, AptameX is an affordable, saliva-based rapid test that uses a DNA aptamer instead of an antibody to detect Covid-19 and is read by a UV Spectrophotometer. The Company believes that DNA aptamers offer a structural advantage over other enzyme-based approaches in sensitivity, specificity, quality of production, lower costs, test formats and other areas.
Achiko previously announced that it in a clinical environment, it had successfully classified results when compared against a PCR test, at above 97% sensitivity and 97% specificity at an average CT score of 28, substantially higher than what many rapid tests are reporting (e.g. “Use of Rapid Antigen Tests During the Omicron Wave” (https://pubmed.ncbi.nlm.nih.gov/34002864/) and “Comparative Evaluation of Panbio and SD Biosensor Antigen Rapid Diagnostic Tests for COVID-19 Diagnosis” (https://covid19-sciencetable.ca/sciencebrief/use-of-rapid-antigen-tests-during-the-omicron-wave/.))
“This matters as the world moves to treating Covid-19 as endemic, key sectors such as aged care, healthcare, manufacturing, and many others need to find a way to cope with Covid’s challenges. PCR testing whilst accurate is often impractical in an endemic setting, and recent research indicates that many rapid tests are simply not sensitive enough to detect the more recent variants”, added Goh.
Achiko has commenced production in Indonesia to meet substantial local demand. To complement this and meet international demand, the Company has secured contract manufacturing with key vendors in Taiwan. The Company expects to respond to customer inquiries from across Europe by sending samples later this month, and to have the product in widespread availability in Q3 2022.
ABOUT ACHIKO AG
Achiko AG (SIX: ACHI.SW; OTCQB: ACHKF; www.achiko.com) is developing disruptive diagnostic solutions that puts people first. The company’s lead product is a rapid, reliable Covid-19 test with a companion app offering a user-friendly digital health passport. The test and companion app were launched in Indonesia in mid-2021 and AptameX received the CE mark in the European Union in May 2022.
Achiko creates and develops aptamer-based diagnostics through its biotechnology division, AptameXTM and companion health apps via its digital mobile health technology division, Teman SehatTM. The AptameX DNA aptamer tests can be rapidly chemically synthesised, are cost-effective and have wide potential across multiple disease diagnostics. Leveraging AptameX and Teman Sehat, Achiko aims to deliver fast, accurate and affordable diagnostic testing for a range of pathogenic diseases and therapeutic indications in the rapidly evolving healthcare diagnostics field.
Headquartered in Zurich, Achiko has offices in Jakarta, and staff around the world.
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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.