A New Paradigm: AptameX, A Synthetic, Saliva-Based Rapid Covid-19 Diagnostic Test with Sensitivity at CT Scores >25
PT Achiko Medika Indonesia and PT Indofarma Tbk are delighted to announce the product and registration emergency use approval of its revolutionary diagnostic test for Covid-19, AptameX. The approval allows for immediate roll-out of the breakthrough DNA aptamer-based non-invasive testing kit, which enables access to low-cost and accurate Covid-19 testing for over 270 million Indonesians. Design and chemistry of AptameX allows for rapid scale-up of production, soon serving millions of people multiple times per month. The production of the AptameXtesting kit will start in September 2021.
JAKARTA, INDONESIA - EQS Newswire - 26 August 2021 - For two years, the world's population has been plagued by the Covid-19 pandemic. In this time, we have seen extraordinary endeavors, such as the rapid introduction of new vaccines and the emergence of a new mRNA vaccine technology. They represent unprecedented advances in international collaboration, science and technology. Despite all our efforts, however, the crisis persists, and we will continue to rely on remarkable medical and scientific efforts if we are to meet the challenges Covid-19 presents. In this context, the need for accurate testing has come to the forefront of consciousness, especially as global vaccination progresses slowly, and papers published in respected journals indicate that booster vaccinations will be routinely required.
How does testing help countries and populations with limited access to vaccination combat the virus and its devastating effects? Vaccination programs promise to curb Covid-19. But governments and businesses are increasingly accepting what epidemiologists have long predicted: the pathogen in a growing number of variants will circulate for years, or even decades. The question therefore is: how can we allow communities to co-exist with the virus, as is the case with endemic diseases such as flu and measles?
Vaccination theory essentially postulates that herd immunity must be achieved and that, consequently, vaccines must prove effective enough to limit the global spread of Covid-19 to a controllable endemic level. Until such time, the requirement is to anticipate and control the spread of the contagion – and routine testing is now recognized as an essential addition to the existing arsenal we have in the fight against the spread of the virus and its variants, all the while continuing the vaccination program.
Mass testing opens door to normal life
Currently, testing is considered as an obligation or a procedure that must be carried out when a patient exhibits symptoms that indicate the presence of Covid-19. However, this is both inefficient and debatably failing to contain and manage the spread of the virus. Epidemiologists from renowned institutions such as Harvard's Wyss Institute of Biologically Inspired Engineering are therefore calling for a clear shift in strategy. They are advocating for a cheap, daily test that can be as effective as the vaccine approach in interrupting transmission; this is the challenge Achiko AG is taking on.
Routine accurate testing is a much needed viable option for the management of viral transmission in order for us to return to the approximation of a normal life. Work, school and social contacts must be able to continue. We need this as individuals, as society and ultimately from an economic perspective.
Mass testing is a necessary requirement to this end. In response to this condition, Achiko AG, in collaboration with PT Indofarma Tbk, held an online talk show on Clinical Talks discussing why frequent Covid-19 testing is necessary. The talk show was entitled "Diligent Covid-19 Testing: The New Normal" and was held on Thursday, 26 August 2021 with speakers:
1. Steven Goh, CEO, Achiko AG
2. Dr Morris S. Berrie, President, Achiko AG
3. Windiaprana Ramelan, Senior VP Operations Asia, Achiko AG
4. Dr Michael Edel, Inventor, AptameX
5. Arief Pramuhanto, President Director (CEO), PT Indofarma Tbk
6. Wanda Hamidah, Health & Lifestyle Influencer
7. Raymond Tambunan, Psi., MSos., Psychologist
8. Professor Amin Soebandrio, Dr, PhD, SpMK(K), Head of Eijkman Institute of Molecular Biology
9. Dr Winda O. Panjaitan, Moderator
At the event, Achiko AG was pleased to announce the approval of their AptameX diagnostic test for Covid-19, developed with a world leader in diagnostics and stem cell research. This product, which obtained a marketing permit granted by the Indonesian Ministry of Health with Circulation Permit Number AKD 20303121654 on 13 August 2021 and as such is now approved and registered for immediate use, is a new test with considerable advantages that enables mass testing. The test is based on a new chemistry involving DNA aptamers instead of costly enzymes and Achiko AG are delighted that the diagnostic kit has received approval allowing for immediate roll-out; Achiko AG's aim is to help contain the spread of the virus through continuous accurate detection. Developed and clinically trialed in Pekan Baru, Indonesia, the test results show sensitivity figures that are superior to a typical lateral flow rapid test.
"We are proud and pleased to receive approval for the groundbreaking AptameX test kit. Introducing AptameX to the market with PT Indofarma Tbk is a great achievement for us," said Steven Goh, CEO of Achiko AG. "With the projected vaccination rate and the possible mutation of the Covid-19 virus, the next few years may be very challenging not only for Indonesia, but also for the whole world. The combination of AptameX and Teman Sehat provides a solution for the entire community to carry out easy-to-use tests at affordable prices as well as digital passport services that will empower them in the fight against Covid-19 and all its variants."
The advantages of AptameX to both PCR testing and current lateral flow rapid tests are obvious:
AptameX is fast, with results in 10 minutes; this is identical to all lateral flow rapid tests;
AptameX is non-invasive, easy-to-use and involves a saliva-based test that produces a digital passport which is made available to a mobile phone in minutes;
AptameX is affordable; equivalent to the cost of a simple lunch;
AptameX is accurate with 80% sensitivity at a CT score of 28.3, and;
AptameX is synthetic. Millions of tests can be produced which is simply not practical for RT-PCR tests.
A global priority: update testing
Achiko AG's efforts can be placed in a context that goes beyond Indonesia. For instance, the mandate of the USA's FDA is to update testing as a priority next year and Achiko AG stated a compelling case for AptameX. PCR testing is neither suitable nor practical for mass testing; the numbers are irrefutable. The results can alone take up to 72 hours to be returned. Only 400-600 million RT-PCR tests can be produced worldwide each month. Additionally, RT-PCR tests are expensive, costing around a minimum of USD 80-100 per test which is at least 40 times as expensive as AptameX. The conclusion is clear: AptameX, thanks to its scalability, can achieve what RT-PCR tests cannot, namely mass testing – and at a significantly lower price.
This is important because epidemiologists and virologists increasingly agree that to sustainably manage the pandemic, we need both vaccination and accurate mass testing, enabling us to rapidly isolate infected individuals to contain and prevent the spread of the virus. AptameX improves current protocols by the very factor epidemiologists and virologists are looking for.
Dr Morris S. Berrie, President of Achiko AG, commented, "Our team is relentless in their commitment to developing our technology for rapid and affordable diagnostic testing, for Covid-19 and other indications to come. AptameX is designed to be easy to use and affordable, and therefore accessible to anyone. We believe AptameX and our digital passport technology platform, Teman Sehat, will be important diagnostic resources for years to come."
Consequently, Achiko AG are positioning themselves as an enabler to what RT-PCR can do, i.e. be the WHO accepted gold standard, but also as an enabler of what PCR can't do: test Indonesia's population of 270 million people four times a month.
The second driver of success: early detection
The use of testing as a means to control Covid-19 requires detection of the virus at an early stage when infected individuals are already highly contagious – and that in itself is a problem. The average person who becomes infected with Covid-19 begins spreading the virus at a time when he or she is not yet symptomatic, and the viral load is so low that it is virtually undetectable with current rapid tests. At the moment, only an RT-PCR test with a CT value of 28 can prove that such a person is infected. This is because even the best published rapid lateral flow test has only 11 % sensitivity at such a CT value. AptameX, on the other hand, is 77.6% sensitive at a CT value of 28.3; more specifically, AptameXreports a sensitivity of 77.59% (95% CI: 75.94 - 79.24).
To illustrate this more clearly: the difference in a PCR test with a CT score of 18 versus 28 represents an accuracy that is 1,024 times greater. AptameX is possibly a thousand times more sensitive than a typical rapid test.
The world needs AptameX
Speakers on the talk show emphasized the need for citizens to undergo frequent testing as a safety measure so that they can live the "new normal" and go about their daily activities.
"Achiko Medika Indonesia plans to commence production of its introductory AptameX Covid-19 test kits over the next two months. A mainstream, consumer-friendly AptameX test kit is expected to be available to Indonesians by the fourth quarter of this year", stated Windiaprana Ramelan, Senior VP of Operations, Asia of Achiko AG. "Users will be able to easily conduct testing by rinsing with a mouthwash, collecting a saliva sample and dropping it off at a partner clinic or hospital which will then deliver the test results to their smart phone in minutes through our digital passport technology platform, Teman Sehat. AptameX was strategically designed to utilise ultra-low-cost materials allowing for lower production costs, which enables Achiko Medika Indonesia to initially price AptameX below IDR 50,000 (~USD 3.45). Achiko Medika Indonesia anticipates an even lower cost of testing in the future as manufacturing and distribution efficiencies are captured."
PT Indofarma Tbk's President Director, Arief Pramuhanto, stated, "Regular testing is very important in dealing with the pandemic. AptameX is a Covid-19 diagnostic test kit produced domestically by and for the people of Indonesia. We hope that the issuance of permits for AptameX products can help in overcoming the pandemic in Indonesia. Achiko AG's saliva-based diagnostic test has been designed to be integrated into normal dental hygiene rituals and therefore can easily become part of the daily routine. With the population having access to reliable testing, we can create pathways that will allow us all to lead normal lives again and at the same time we work to control the spread of Covid-19. PT Indofarma Tbk, in partnership with Achiko AG, aims to make this diagnostic test available at an affordable price for everyone. AptameX's cost, scalability and performance will help Indonesia better manage Covid-19."
The world needs AptameXfor regular, accurate, cheap and readily available mass testing.
Achiko creates and develops new innovations in healthcare technology through its biotechnology division, AptameXTM, and its sister digital mobile health technology division, Teman SehatTM. 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.
AptameXTM comprises of DNA aptamer-based technology that is cost-effective, chemically synthesised and widely applicable to the evolving diagnostic field of healthcare. Together with the digital mobile health app Teman SehatTM, Achiko is developing potential technologies that seek to deliver rapid, affordable diagnostic testing for a range of pathogenic diseases and therapeutic indications. The AptameXTM 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.
Achiko AG and PT Indonesia Farma Medis ("IFM") have established the joint venture company PT Achiko Medika Indonesia ("AMI") for the production and marketing of its testing platform developed from AptameXTM, a non-invasive DNA aptamer technology for the detection of Covid-19, for Indonesia. Its partner, IFM, is a medical device and pharmaceutical distribution company with a large network of relationships and distribution channels that includes hospitals, pharmacies and clinics across the main islands of Indonesia.
PT Indofarma TBK is one of Indonesia's oldest pharmaceutical companies that was founded in 1918 and in January 2020 became part of the BUMN Farmasi Holding.
PT Indofarma TBK continues to support the Government of the Republic of Indonesia programs in the health sector and contribute to improving health status and a better quality of life by committing to provide medicines with guaranteed quality and affordable prices for the community. In addition, the Company also supports the efforts of the government of the Republic of Indonesia in accelerating the handling of the Covid-19 pandemic by providing pharmaceutical products and medical devices, as well as health services. To date, Indofarma has had 321 distribution licenses for medicinal products and medical devices with distribution coverage spread across 29 branches throughout Indonesia.