Pilot program in Indonesia is on track with positive results and support for Achiko’s proprietary, low-cost rapid Covid-19 diagnostic test, AptameX, alongside its sister digital passporting service Teman Sehat (“Health Buddy”)
Approval for the second-generation AptameX test kit expected in December from Indonesia’s Ministry of Health
CE Mark registration is close to finalization with filing early next year
Initial production of first-generation AptameX test kit is underway in Indonesia to fulfil prior sales orders and shipment early next week
ZURICH, Switzerland, Nov. 24, 2021 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR –Achiko AG (SWX: ACHI, ISIN CH0522213468) (“Achiko”, the “Company”) is pleased to report substantial progress with the commercialization of both its rapid Covid-19 diagnostic test AptameX™ and its sister digital passporting service Teman Sehat™ (“Health Buddy”) with its pilot program, initial production and regulatory approvals proceeding as scheduled.
“We’re excited about the Company’s progress,” said Steven Goh, CEO and Co-Founder of Achiko AG. “It’s apparent with the events unfolding in Europe and the rising challenge of booster shots, that for many countries, Covid-19 is likely to remain a challenge for years to come and with a best-in-market product such as AptameX, we’re going to be there to meet that challenge and enable countries to live with Covid-19.”
Pilot Program
The pilot program has been proceeding in Bali and surrounding areas to Jakarta and has been well-received with participants pleased with the assurance services. Early data confirms the Company's expectations regarding the strength of the underlying value proposition of being fast, accurate and cost-effective, and the resulting high customer acceptance and adoption. Also confirmed is the efficiency of the workflows and their support of the platform business model.
Achiko's next steps include further product enhancements in advance of AptameX’ widespread introduction into the market. The Company is preparing to scale-up production in Indonesia and will ensure its portability to other countries.
Regulatory Approvals
The Company is making progress in Indonesia and, through a CE Mark, expects to meet European and global demand. AptameX represents the first massive use of DNA aptamers at scale versus classical antigenic approaches to rapid tests. Aptamer-based tests are deemed superior to antigen-based tests because they can have a greater target affinity and specificity, smaller size, ease in modification and immobilization, better stability, higher reproducibility, and lower costs.
In Indonesia, the Company has filed for its second-generation product with an expected approval in December. Additionally, post approval validation work is expected to complete in December thus allowing the Company to get onto government purchasing lists.
For the CE Mark registration the only two material items outstanding are the appointment of an original equipment manufacturer (OEM) partner and the completion of the clinical investigation report. The Company is expecting to close on an OEM shortly and will provide an update at that time. As for the clinical investigation report, the Company is looking for a location outside of Indonesia to replicate the work done in Spain and Indonesia. At its current rate of progress, the Company expects to be able to file for the CE Mark in Q1 2022.
Production
To meet initial sales in Indonesia and build a pipeline around the world, the Company has commenced production of its first-generation and is planning to move to its second-generation product this quarter.
Key components for AptameX first-generation test kits have arrived in Indonesia and an initial 50,000 kits will be produced on site at the Company’s manufacturing partner, PT Indofarma Tbk. This batch of kits will fulfil prior sales orders received last month from Jakarta and Bali in Indonesia. A follow-on production of an additional 144,000 first-generation test kits will be available for delivery shortly with the majority going to first sales, and samples being sent to various provinces in Indonesia and to other countries in Asia, the Middle East, Europe, and Australasia.
The Company has been able to significantly optimize expenses for the second-generation of the product. The cost of the reagent is now expected to be less than $0.10 per test, an improvement of about 15%, and the cost of plastics is now $0.20 per test, less than half of the original costs.
For production to meet international demand stemming from a CE Mark, the Company is looking to centralize core manufacturing in Taiwan, with plastics produced locally there or in the country where the tests are being distributed.
“Chemistry is our difference,” added Steven Goh. “The use of aptamers instead of antigens is yielding a lower cost, more sensitive test and in a format that is both consumer friendly and timely. In a world of rapid tests and PCR tests, AptameX can be well positioned between both as an effective screener and again, to help us live with Covid-19 and get on with our lives.”
ABOUT ACHIKO AG
Achiko creates and develops new innovations in healthcare technology through its biotechnology division, AptameX™, and its sister digital mobile health technology division, Teman Sehat™. The Company has created a unique healthtech capability that provides user-friendly diagnostic testing integrated with a digital passport solution for the management of Covid-19.
AptameX comprises of DNA aptamer-based technology that is cost-effective, chemically synthesized and widely applicable to the evolving diagnostic field of healthcare. Together with the digital mobile health app Teman Sehat, Achiko is developing potential technologies that seek to deliver rapid, affordable diagnostic testing for a range of pathogenic diseases and therapeutic indications. The AptameX technology is licensed from Regenacellx.sl and Achiko has exclusive commercialisation rights.
Headquartered in Zurich, Achiko has offices in Hong Kong, Jakarta, Seoul, and Singapore.
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.
