Achiko AG
Achiko AG Obtains CE Mark for AptameXTM Covid-19 Rapid Test
Achiko AG / Key word(s): Expansion Achiko AG Obtains CE Mark for AptameXTM Covid-19 Rapid Test – 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 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 AptameXTM DNA aptamer tests can be rapidly chemically synthesised, are cost-effective and have wide potential across multiple disease diagnostics. Leveraging AptameXTM and Teman SehatTM, 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. Media contacts: Switzerland & Global Disclaimer Additional features: File: Achiko AG Obtains CE Mark for AptameXTM Covid-19 Rapid Test End of ad hoc announcement |
Language: | English |
Company: | Achiko AG |
Tessinerplatz 7 | |
8002 Zurich | |
Switzerland | |
E-mail: | ir@achiko.com |
Internet: | https://www.achiko.com/ |
ISIN: | CH0522213468 |
Valor: | 48788430 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 1353885 |
End of Announcement | EQS News Service |