Achiko AG | January 15, 2022
Achiko AG is pleased to report that new optimizations 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 cycle threshold 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. 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 where vaccination rates are lower and the leading testing technologies are impractically expensive for the vast majority of people.”
Achiko CEO Steven Goh
New data announced 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.
These results compare favorably 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 specialized 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 Euro surveillance, 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 optimized 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 commercialization in Europe, the Middle East and Asia 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.”
ABOUT ACHIKO AG
Achiko AG 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.
National Comprehensive Cancer Network | October 16, 2020
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.
Pressure BioSciences, Inc. | October 07, 2020
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide biotechnology, biotherapeutics, and other industries, today announced the achievement of a critical milestone: the lock-in of final design specifications for the commercial production model of its proprietary, next-generation Ultra Shear Technology™ ("UST™")-based nanoemulsification system. Following achievement of this milestone, the Company has begun to build the initial "Alpha" unit of the commercial model. Once built, tested, and approved, the Company will immediately proceed to build an additional 15 ready-for-sale systems, thus enabling PBI to meet its goal of shipping the BaroShear K45 UST System in early (Q1/Q2) 2021. Based on the Company's patented UST platform, the BaroShear K45 is a unique breakthrough nanoemulsification system designed to resolve one of the most substantive problems facing manufacturers of biotherapeutic drugs, nutraceuticals (including hemp-derived CBD products), and other products containing oil-based active ingredients that are at best poorly soluble in water. As with any oil-based product, it is difficult for the water-based biochemistry of humans and other animals to access and absorb the active ingredients hidden within oil drops. Poor water solubility leads to lower absorption and bioavailability of active ingredients, which makes it particularly difficult to design and deliver proper dosing of the desired compound. More recently, growing science around nanoemulsion development has shown that oil-based active ingredients manufactured into high quality nanoemulsions have delivered dramatically increased absorption and bioavailability, resulting in higher quality finished products for the consumer.