Achiko AG / Keyword(s): expansion
Achiko AG Obtained CE Mark for AptameXTM Covid-19 Rapid Test
05/17/2022 / 06:45 CET / Central CEE
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Achiko AG obtained the CE Mark for AptameXTM covid-19 rapid test
– Achiko AG has registered its AptameX fast Covid test and received the CE mark, allowing the product to be sold in 27 EU countries.
By using DNA aptamers, AptameX has unique performance advantages over other rapid tests.
The company expects AptameX to be widely available in the third quarter of 2022.
Zurich, 17 May 2022: Special Announcement in accordance with Article 53 KR – Achiko you (SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, “the Company”) is pleased to announce that AptamixThe COVID Rapid Test has now been successfully registered under the Medical Device Research (MDR) and In Vitro Diagnostic Act (IVDR) and has received the CE mark. The label gives AptameX’s COVID-19 test and system access to 27 countries in the European Union and forms the basis for additional regulatory approvals around the world.
“This is the first major application of DNA aptamers in a consumer test product and a great milestone for Achiko,” said Stephen Goh, CEO of Achiko AG.
Unlike other rapid test formats, AptameX is an affordable saliva-based rapid test that uses aptamer DNA instead of an antibody to detect Covid-19 and is read with a UV spectrophotometer. The company believes that DNA aptamers offer structural advantages over other enzyme-based methods in sensitivity, specificity, production quality, cost, assay formats, and other areas.
Achiko previously announced that it had successful results with a sensitivity of over 97% and specificity of 97% with an average CT score of 28 compared to a PCR test in a clinical setting, a result much better than that of many. Other rapid tests (eg “Using rapid antigen tests during the Omicron wave”)https://pubmed.ncbi.nlm.nih.gov/34002864/) and «Comparative evaluation of the Panbio antigen and SD-Biosensor rapid tests for the diagnosis of COVID-19» (https://covid19-sciencetable.ca/sciencebrief/use-of-rapid-antigen-tests-during-the-omicron-wave/.))
“This is important. Globally we are moving to deal with Covid-19 as endemic and key sectors such as aged care, healthcare, manufacturing and many other industries and service sectors need to find a way to deal with the challenges posed by Covid.” Despite the accuracy of the PCR tests, Stephen Goh said. (PCR), they are often impractical in an endemic environment, and recent research shows that many rapid tests are simply not sensitive enough to detect newer variants.
By producing AptameX in Indonesia, Achiko caters to a large domestic demand. In addition, to meet international demand, the company has entered into contract manufacturing agreements with major suppliers in Taiwan. The company expects to be able to respond to customer orders from across Europe by shipping samples later this month and to have the product generally available in the third quarter of 2022.
About ACHIKO AG
Achiko AG (SIX: ACHI.SW; OTCQB: ACHKF; www.achiko.com) Develops advanced diagnostic solutions that put people first. The company’s flagship product is a fast and reliable Covid-19 test with a companion app that provides an easy-to-use digital health passport. Testing and accompanying application were launched in Indonesia in mid-2021, in May 2022 AptameX was receivedTM European Union CE mark.
Achiko creates and develops aptamer-based diagnostics through its biotechnology division, AptameXTM and accompanying health applications through the Department of Digital Health Technology for Mobile Devices, Timan SehatTM. AptameX DNA aptamer tests can be chemically manufactured quickly, are inexpensive and have great potential for diagnosing various diseases. Using AptameXTM And Timan SaihatTM Achiko aims to provide rapid, accurate and affordable diagnostic tests for a range of pathogenic diseases and therapeutic indications in the rapidly evolving field of healthcare diagnostics.
The headquarters of Achico is located in Zurich. The company has offices in Hong Kong, Jakarta, Seoul and Singapore.
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This communication expressly or impliedly contains certain forward-looking statements regarding Achiko AG and its business. These statements include known and unknown risks, uncertainties and other factors, which could cause the actual results, financial position, performance or achievements of Achiko AG to be materially different from any future results, performance or achievements expressed or implied by these statements. future expectations. formulations. Achiko AG provides this communication as of this date and does not undertake to update any forward-looking statements contained as a result of new information, future events, or otherwise.
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