ANNOUNCEMENT TEST
Achiko AG Production and Sales Update
- Unique chemistry with DNA Aptamers Completing pre-sales validation testing
- Completing pre-sales validation testing in Indonesia
Zurich, 3 March 2022: Ad hoc announcement pursuant to Art. 53 LR – Achiko AG (SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, the “Company”) today announced an update to its production and sales plans for its Covid-19 testing platform AptameXTM in Q2 2022.
The Company is currently completing pre-sales validation processes in Indonesia, and is moving to establishing supply chain from Taiwan to the rest of the world. Future market development in Indonesia will be supported by the Company’s presence in Indonesia and supply from Taiwan. Global demand will be met by resources in Taiwan, Spain and Australia. Additionally, it is commencing a clinical investigation report in Australia as part of its international sales effort, and as the last remaining key part of its CE Mark.
“As President Biden announced in his State of the Union Address this week, the response to Covid-19 is moving to test and treat,” said Steven Goh, CEO of Achiko AG. “AptameX’s unique chemistry gives it performance advantages over other rapid tests and a price and time performance advantage over molecular approaches such as RT-PCR.”
“As the world moves to treating Covid-19 as endemic, we believe that the demand for testing shifts but in the end, becomes larger as a whole. It’s great to see some countries like the United Kingdom moving quickly to a new normal, however as the situation in Hong Kong and other countries shows, this is likely to be a challenging future,” added Goh.
AptameX is based around the use of DNA aptamers encoded to the S1 protein, in a colloidal gold solution with the results obtained using a UV Spectrophotometer and software. Unlike antigen-based rapid tests which are based around an antigen reacting with the N1 protein, the S1 is exposed on the surface of the virion in 24 to 40 or so spikes.
“As our recent classification results show, unique chemistry has both been an asset for the company and a liability with it taking longer to commercialise and register something new. We’ve been doing this largely over Zoom. We’re over the hump of it now, and as some travel opens up we’re expecting things to accelerate from here,” said Goh.
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.
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.
Achiko AG Research Paper and Commercialisation Update
- 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.
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.
Achiko AG strengthens senior team with appointment of Head of Corporate Development
- Achiko AG appoints David Hodge to the role of Head of Corporate Development in Switzerland
- David Hodge will oversee Corporate Affairs, and Strategic and Corporate Development
- Board Director Christophe Laurent to retire at month end
Zurich, 27 January 2022: Ad hoc announcement pursuant to Art. 53 LR – Achiko AG (SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, the “Company”) appoints strategic and corporate development executive David Hodge to the position of Head of Corporate Development and announces the retirement of Christophe Laurent as Board Director.
Mr Hodge brings over 30 years’ experience as a C-suite executive including Australia’s then largest private equity firm (SBC Capital Partners), global investment banking (UBS), global manufacturing (Amcor) and industrial services businesses (Worley), and technology software businesses, with a focus on shareholder value creation. His broad sector experience includes healthcare, manufacturing, technology, and banking and finance.
He has been a strategic and corporate development advisor to world leading companies on business transformation and strategic challenges in emerging and developed markets, with a focus on profitable strategic growth. Clients have included ADM, Allnex, Amcor, AMVIG, Bayer, BTG, Campbells, Cornelius, Countrywide, Graphic Packaging International, MedHealth, NCO, Neovia, Nexans, Nine, SATS, SGH, Smith Group, Sumitomo, TGI Fridays, West Pharmaceutical, and Worley.
Previously, Mr Hodge led major capital raisings in Australia, Hong Kong, China, South East Asia, USA and Europe. He has led global strategic projects on every major continent and implemented numerous M&A projects worldwide. Mr Hodge has served as a Director and Chairman of public listed and private companies in Asia Pacific. He holds a Bachelor of Economics and Bachelor of Laws from Monash University in Australia.
Mr Hodge is responsible for the development of Achiko’s corporate presence especially in Switzerland, including for all matters regarding the development of the Board, corporate finance, and investor relations in its transformation to a world class diagnostics company.
Mr Hodge started his role as Head of Corporate Development on 21 January 2022.
As previously announced, Board Director Christophe Laurent will retire on 31 January 2022. The Company will appoint a replacement for Mr Laurent on or before the Annual General Meeting.
“As the Company pursues CE Mark registration for our affordable, non-invasive Covid-19 rapid test AptameX™ in Q1 2022, we are excited to welcome Mr Hodge to our senior team. His rich strategic and corporate development experience will bring a new dimension to Achiko as we prepare for commercialisation beyond Indonesia,” said Achiko CEO Steven Goh. “In addition, the Board of Directors is grateful for the efforts of Mr Laurent and I would like to thank him personally as his broad contributions across the company helped grow Achiko to where we are today.”
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.
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.
Achiko AG Reports Breakthrough Calibration Results for AptameX Covid-19 Rapid Test Technology
- AptameX™ Covid-19 rapid calibration successfully classified 100% of results indicating
a likely > 97% Sensitivity and > 97% Specificity result in the first-generation test kits. - Results were demonstrable both at CT values under 25, and between 25 to 33, indicating superior test performance to other rapid tests
- Achiko is now moving to scale production and completing CE Mark to respond to global demand
Zurich, 14 January 2022: Ad hoc announcement pursuant to Art. 53 LR – Achiko AG (SIX: ACHI; OTCQB: ACHKF; ISIN CH0522213468) (“Achiko”, the “Company”) is pleased to report that new optimisations during recent calibration testing of its affordable, non-invasive Covid-19 saliva-based rapid test AptameX™ correctly differentiated 100% of test samples up until a comparable reverse transcription polymerase chain reaction (RT-PCR) cycle threshold (CT) value of 33, indicating the system’s ability to deliver a > 97% sensitive and > 97% specific rapid test at a wider range of viral loads than most other rapid tests.
“The data we’re reporting today shows that our technology allows for more sensitive and affordable tests compared to antigen-based tests,” stated Achiko CEO Steven Goh. “These high-fidelity calibration testing results suggest not only that AptameX has potential as a very compelling alternative to rapid antigenic tests, but also may be used as an accurate alternative in many mass market applications to slow and expensive RT-PCR technology. This is particularly important in Lower to Middle Income Countries (LMIC) where vaccination rates are lower and the leading testing technologies are impractically expensive for the vast majority of people.”
New data (see table below) announced today for the first time show that, after the recent improvements, AptameX achieved 100% sensitivity and specificity in a controlled experiment in 58 human Covid-19 samples. These gains both confirm AptameX’s ability to perform at low viral loads.
The experiment was conducted in Indonesia using samples that were confirmed positive or negative for SARS-CoV-2. AptameX delivered a sensitivity of 100% across a range of CT values below 25 and CT values within the 25-33 range, which is important as the sensitivity of other rapid tests typically drops dramatically in the 25-33 CT value range. The results are consistent and extend earlier work in Spain and other testing in Indonesia. Achiko is looking forward to replicating the study internationally as it moves to complete its CE Mark.
| CT Value (mean & range) | Number of Specimens | Classification for Sensitivity | |
| High (CT =< 25) | 17.6 / 13.4 – 23.0 | 16 | 100% |
| Low (25 < CT =< 33) | 30.5 / 25.8 – 33.0 | 12 | 100% |
| Negative | – | 30 | – |
| Average | 23.15 / 13.4 – 33 | 58 | 100% |
These results compare favourably to other testing technologies. Because of its accuracy, RT-PCR technology has become the gold standard for detecting Covid-19 infection. However, RT-PCR is often not the most practical for large-scale testing because it requires specialised equipment, is relatively slow and expensive. Using RT-PCR technology, scientists have established a benchmark for detecting Covid-19 infection: a healthy person is considered Covid-19 negative if their RT-PCR CT value is greater than 33. If, however, the CT value is below 33, the person is Covid-19 positive. Most rapid tests may tout a high sensitivity result where the CT values are under 25. However, according to Eurosurveillance, more recent work on Omicron indicates the mean value for Covid-19 infection is around 28, hence the frequent reports of lower sensitivity in the majority of antigenic rapid test kits. Therefore, the AptameX result is important as it presents a viable alternative to other testing.
“The improved sensitivity and specificity results announced by Achiko following completion of calibration testing on its SARS-CoV2 rapid test kit is a significant milestone”, stated AptameX inventor Dr Michael Edel. “AptameX has the capability to meet the increasing global need for frequent mass testing that is fast, low-cost and non-invasive.”
Furthermore, the AptameX test has completed and tested its first few hundred thousand kits in production and is now moving to produce one million kits a month. From there, the format is highly amenable to large-scale manufacturing and offers a considerable production cost advantage. Late last year the Company optimised the first-generation test kit using a simpler supply and manufacturing chain in Taiwan and Indonesia, that can easily be replicated to other geographies. In a matter of months and subject to financing, production capacity can rapidly be scaled to hundreds of millions of kits per month. The Company is looking to finance scale production primarily through trade finance.
Production of the second-generation rapid test kits is underway and will ramp up further this quarter. Shipments of AptameX kits within Indonesia have been completed to meet prior sales orders as the Company expects to be able to provide 3-4 tests per months for 5% of Indonesia’s 270 million population by mid-year. Additionally, a CE Mark registration is expected in early 2022, allowing the Company to respond to inquiries and move towards commercialisation in Europe, the Middle East and Asia (EMEA) and elsewhere.
“It’s evident that as we move to the endemic phase of covid-19, regular vaccinations and mass testing will become a part of our daily lives”, added Goh. “We are enormously pleased with the great results we are able to share today. They confirm the competitive positioning of the platform and the role we can play in getting us all back to a ‘normal’ life.”
Find out more about DNA aptamer technology and how AptameX compares to other rapid tests and PCR tests in this video interview with CEO Steven Goh at https://youtu.be/KdBZZRMp26k.
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.
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.
