Achiko AG Research Paper and Commercialization Update

Rhea-AI Summary

Achiko AG has released a draft paper detailing the results of a calibration study for its DNA Aptamer Gold Nanoparticle Colorimetric Diagnostic Test Kit for SARS-CoV-2. This test, part of AptameX™, achieved over 97% sensitivity and specificity in controlled trials with 58 human samples. The company is now sending second-generation kits for preproduction evaluation and is working towards CE Mark approval, including a clinical investigation site in Australia. Achiko’s solutions aim to provide an effective alternative to traditional PCR testing, with benefits in cost, performance, and user experience.

Positive

• Achiko's test kit achieved over 97% sensitivity and specificity in trials.
• First application of DNA aptamers in commercial diagnostics, offering cost-effective production.
• Progress toward CE Mark approval with planned clinical investigations.

Negative

• None.

• 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, Switzerland, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR – Achiko AG (OTCQB: ACHKF; SIX: ACHI; 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 optimizations in the use of materials, in stability, reduction in costs, ease of production, and other identified elements.   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 finalizing 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/10.1101/2022.02.09.22269224v1

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, AptameX™ and companion health apps via its digital mobile health technology division, Teman Sehat™. The AptameX DNA aptamer tests can be rapidly chemically synthesized, 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.

Media contacts:
ACHIKO AG
Investor Relations
E: ir@achiko.com

Switzerland & Global
Marcus Balogh
Farner Consulting Ltd.
E: achiko@farner.ch
T: +41 44 266 67 67

U.S. & Global
Jeanene Timberlake
RooneyPartners
E: jtimberlake@rooneypartners.com
T: +1 646 770 8858

Disclaimer
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.

FAQ

What are the key findings of Achiko AG's calibration study for the test kit?

Achiko AG's calibration study showed that their test kit achieved over 97% sensitivity and specificity at cycle threshold values under 25.

What is the significance of the AptameX™ test kit?

AptameX™ is significant as it is the first commercial application of DNA aptamers in diagnostics, outperforming traditional tests in sensitivity and cost.

What steps is Achiko AG taking towards obtaining CE Mark approval?

Achiko is working on clinical investigations in Australia and has secured an OEM in Taiwan to support CE Mark requirements.

What advantages does the AptameX™ test offer over traditional PCR tests?

The AptameX™ test offers advantages in cost, performance, and a more user-friendly experience compared to traditional PCR tests.

When was the calibration study for Achiko AG's test kit announced?

The calibration study results were announced following completion in December, with updates shared in early January.