It’s been a busy start to the year at AgPlus building on the successes of 2021 and setting the wheels in motion for a transformational year in 2022 as the development stages of the Agilis platform are completed.
Core milestones were achieved in 2021 and the objectives for 2022 are clear:
- Demonstration of Agilis reader and cartridge – achieved in November 2021
- Increased robustness of assay chemistry for production – achieved in January 2022
- Clinical verification of assays on Agilis reader and cartridge
- Final design for manufacture of Agilis platform
- Engagement with B2B customers prior to CE Marking of Agilis reader and regulatory submission of first products
The development of our Agilis platform is central to our success in 2022. Good progress has been made on the Agilis reader during 2021 and it has performed consistently during recent trials. Successful demonstration of the Agilis platform at the Medica 2021 exhibition in Dusseldorf was achieved in November and particularly encouraging feedback was forthcoming on the high level of process detail shown on the onboard screen.
During December and early January the initial batch of Agilis final prototype readers have undergone servicing and stress testing prior to clinical verification trials in early 2022.
AgPlus is proud to announce we have been recertified by BSI (ISO 13485:2016) after a successful audit. It reestablishes that AgPlus Diagnostics is developing its Agilis technology in compliance with the highest standards for safety and product performance, and enables the company to make its product available for the first patient treatment once approved.
The appointment of Dr Nic Christofides as CSO and Dr Tito Bacarese-Hamilton as interim CTO in September has led to additional focus on improving consistency of performance of assays prior to transfer into the Agilis cartridges. This work has led to greater confidence in factors critical to quality, as well as increasing the robustness of all AgPlus assays prior to initial regulatory applications.
Aligned to this successful work on assay performance, the AgPlus team is making greater use of external expertise; as the Agilis platform approaches production readiness it is vital that AgPlus continues to utilise its access to state of the art expertise in all aspects of its work in order to minimise the risk of delays. Great collaboration is a core value at AgPlus.
AgPlus’s longstanding strategy of collaborating with B2B partners with existing access to the market has established a substantial pipeline of customers. Once a committed timetable for minimum viable product in the market is established the business development team process will accelerate quickly.
The AgPlus team was encouraged at Medica 2021 by the significant level of interest in the Agilis platform as a credible and advanced stage technology in fast, fully quantitative near patient testing. Time to market remains critical in retaining this key advantage.
The AgPlus Vision and Mission remains clear:
Vision: To be a recognised global leader in innovative near patient diagnostic testing, matching each patient’s critical condition to the right treatment at the right time.
Mission: Answering a key challenge of health services worldwide by providing accurate, cost effective near patient testing which expedites patient care and significantly reduces costs.
We look forward to sharing more exciting news with you as the year progresses. In the meantime, take a look at our Agilis reader in more detail here.