- 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%|
|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.
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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.