Achiko AG completed production of the first 1,000 AptameX test kits and has commenced shipment to Indonesia. The Company also announces favourable preliminary Covid-19 diagnostic testing results at a high CT score; even at low viral loads, AptameX proves to be highly sensitive.
· Production of first 1,000 AptameX test kits is concluded in Singapore (initial capacity to test 10,000 patientsper day).
· AptameX delivers sensitivity of 77% (95% CI: 75.94 - 79.24) at a high industry CT score of 28.3, which iscomparable to current lateral flow rapid tests.
· Moving to complete product registration in Indonesia and progressing to securing a CE mark in Europe with a view to approvals and sales in Q3 2021.
Against the background of the expansion of its production capacities in Singapore, Spain, Taiwan and Indonesia, the distribution of the test kits represents an important milestone for the Company, made possible after AptameX recently received a distribution certificate via Achiko’s joint venture partner PT Indonesia Farma Medis (“IFM”) in Indonesia. The Company is progressing forward with product registration and final validation trials, ensuring full test kit availability in early Q3 2021. Achiko’sand IFM’s joint venture company PT Achiko Medis Indonesia will undertake the initial rollout of AptameXand the mobile app Teman Sehat in Indonesia. Achiko earns a profit share relative to its 50% holding and a 10% licensing fee from gross sales. “In geographies with little vaccination coverage, an ultra low cost, accurate testing service is crucial to both ensure safety and restore confidence in workplaces and public spaces amongst consumers, tourists and within manufacturing,” said Steven Goh, Chief Executive Officer of Achiko. “We believe that working together with our partners, reaching just 2% of Indonesia’s population of 270 million may be possible later this year. At 3-5 tests per person per month, that potentially equates to 15-25 million tests per month in Indonesia alone, producing an initial revenue stream of USD 30 - USD 50 milliona month.” In addition, Achiko reports that the testing of AptameX achieved 77% sensitivity (95% Confidence Interval (CI): 75.94 - 79.24) at a favourable CT score of 28.3, from both in-vitro tests in Spain and the subsequent Indonesian field testing of proprietory AptameX chemistry. These tests were conducted in a 96-wellplate format and run against RT-PCR. Scientifically, a CT value signalsthe number of cycles for a sampleto go through to amplifyand bring up the viral DNA to a traceable level. Consequently, the higher the CT score, the lower the viral load that can be detected. Currently, used CT score categories are low (<18.5), meaning the viral load in a sampleis high, normal(18.5-25) and high (>25), meaningthe viral load in a sample is low. It is encouraging that Achiko’s result of 77% sensitivity at a CT score of 28.3 is comparable to all lateral flow testing kits alreadyin the market. The Companyexpects to announcefurther improvement on thesenumbers by a factor of at least 10% and at much higherCT scores.
Progressing to securing a CE mark in Europe
This breakthrough now sees Achiko undertaking selectivity and stability studies in Europe as a precursor to seeking full CE mark registration in Q3 2021. Following the CE mark registration, Achiko will respond to commercialisation interest across Europe, Asia, the Middle East, Africa and the Americas.
These achievements for Achiko underscore the Company’s commitment to developing a rapid, accurate and cost-effective solution to diagnose those with Covid-19. The investments Achiko has made in transitioning from a fintech to a healthtech diagnostic company are beginning to show promise; the technologies of AptameX and TemanSehat offer an extraordinary solutionto managing further outbreaks of Covid-19 and other diseases in the future. Achiko can respond and act swiftly to globalpublic health crises,not least in developing countries.
“I’m confident Achiko will shortly achieve its goal to deliver a diagnostic test that is available to the entire global population,” stated Mr Goh. “The road of transforming the Company to a healthtech entity has not been without its challenges, however, we are now encouraged and excited by the resultsand our recent pace of execution.”
Comments