- Calibration study results now available in draft paper on medRxiv, a preprint platform for health sciences, as “DNA Aptamer Gold Nanoparticle Colorimetric Diagnostic Test Kit of Saliva Samples for SARS-CoV-2 Virus Linked to Mobile Phone Application”
- AptameX is the world’s first scale application of DNA aptamers in a commercial diagnostics setting, and holds advantages in performance, cost and quality of production over other rapid tests
- Second-generation test kits are currently being sent for preproduction evaluation
- Evaluating clinical investigation site in Australia for final CE Mark requirement
Zurich, 14 February 2022: Ad hoc announcement pursuant to Art. 53 LR – Achiko AG (SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, the “Company”) is pleased to announce the availability of its calibration study in a draft paper of AptameX™, on the pre-print medRxiv platform for health sciences.
This follows successful completion of a calibration study in December and announced in early January with its first-generation test kit and use of a commodity spectrophotometer, which documented that AptameX achieved >97% sensitivity and >97% specificity at cycle threshold (CT) values under 25, and between 25 to 33 in a controlled experiment in 58 human Covid-19 samples. Achiko has subsequently applied updated software and algorithms to its last in-vitro study with 338 samples, and notes performance gains over its previously announced results.
In sum, these results confirm AptameX’s ability to outperform other Covid-19 rapid tests and to provide an alternative to the gold standard reverse transcription polymerase chain reaction (RT-PCR) tests, across a wide range of attributes such as sensitivity and specificity, cost, ability to produce at quality and at scale, and in consumer experience.
“This is the first time DNA aptamers have been used in a mass market product”, said Steven Goh, CEO of Achiko AG. “The pandemic has exposed a universe of weaknesses in testing, either in sensitivity and quality in scale in antigenic rapid tests, or in the practical use of PCR testing as a mass testing tool.”
“With these results, healthcare professionals may have a practical alternative to PCR tests, and less accurate antigen based rapid tests. Not only is the test designed to be consumer friendly, but the active chemistry can be produced with consistency at scale, at a cost lower than the key components to a common place antigenic rapid test.”
The Company is currently using its first-generation kits in trial production and in test sites in Indonesia, and has identified a range of improvements, that are being incorporated into its second-generation product. This includes optimisations in the use of materials, in stability, reduction in costs, ease of production, etc. Also, whilst early test kit versions use an established spectrophotometer, future iterations will include a portable spectrophotometer reader about the size of a credit card that can be deployed in a range of clinical to home use settings. In the medium term, the test kits will continue to have key materials produced in Taiwan, and scale plastics and assembly in Indonesia.
The Company has made additional progress towards its CE Mark by securing an original equipment manufacturer (OEM) in Taiwan and has appointed a project manager who is finalising a site inspection to conduct a clinical investigation in Australia. The clinical investigation report is substantially the last key remaining item needed for CE Mark registration and follows a similar report in Indonesia.
“We’re all excited to see some countries get over the worst of the pandemic”, added Goh. “But like influenza this is now with us for the long term and variants will continue to appear year on year, and a testing solution such as ours can be a welcome, friendly and accessible change to the testing experience we’ve all had to endure over the last few years.”
The calibration study “DNA Aptamer Gold Nanoparticle Colorimetric Diagnostic Test Kit of Saliva Samples for SARS-CoV-2 Virus Linked to Mobile Phone Application” can be found here: https://www.medrxiv.org/content/10.1101/2022.02.09.22269224v2
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 an application for CE Mark approval in Europe will be submitted in 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 Hong Kong, Jakarta, Seoul and Singapore.
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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.