GobiX GmbH and Biolytix AG join forces to deliver turn-key CE-certified COVID-19 test kit production systems
Enabling independent onsite production of test kits anywhere and on demand
Baar, Switzerland – 30 June 2020 – GobiX GmbH, a MedTech start-up, and Biolytix AG, an ISO 17025-accredited service laboratory based in Switzerland, announce their partnership to address the global shortage of COVID-19 test kits. This initiative is empowered by Formlabs, a leading 3D printing company. The partnership will allow GobiX GmbH to quickly provide COVID-19 nasal testing swabs, virus-deactivating and conserving lysis buffer for fluid collection and knowledge transfer to ramp up independent testing facilities anywhere in the world where they are needed.
The multi-disciplinary team of experts from GobiX GmbH and Biolytix AG quickly came together in Switzerland following a shortage of COVID-19 test kits – particularly the nasopharyngeal (NP) swabs – during the peak of the outbreak in Switzerland in March. In less than a month, Switzerland had sufficient means and know-how to produce its own test kits to cover the testing of people with COVID-19 symptoms.
The swabs and viral-collection fluid normally used in Switzerland prior to the COVID-19 crisis were produced in other countries, leaving Switzerland vulnerable to supply chain disruption. Because of global shortage, and in order to be independent of international supply chains, the Surgeon General of the Swiss Armed Forces, responsible for coordinating preparations and the deployment of Swiss public health resources in special and exceptional situations, launched a collaborative effort to develop production inside Swiss borders.
Thanks to swift collaboration between the Swiss Armed Forces, GobiX GmbH, its partner Biolytix AG, and volunteer healthcare experts, Switzerland now has a COVID-19 test production chain enabled by Formlabs 3D printing technology within its borders that was put in place in less than a month.
During this time, GobiX GmbH applied its medical and engineering expertise, and tapped into its network to create a scalable, fast system for swab and transportation fluid production. The swab design – developed by GobiX GmbH co-founder Patrice Gobat, a mechanical engineer and 3D printing expert from the Swiss Federal Institute of Technology in Zurich (ETH) – can be printed at scale on demand, with each office-printer sized printer having a capacity of up to several hundred swabs per day.
Physician and GobiX GmbH co-founder, Michel Bielecki, said that who lead the prototyping and deployment of the solution, said, “Two of the big problems with COVID-19 testing are 1 – the availability of testing kits because we rely on external production and 2 – accuracy and comfort since the use of a cotton swab, currently widely-used due to no other options, can be very unpleasant and is highly inaccurate for diagnostic purposes. Our solution doesn’t completely solve the shortage, but it ensures that we have an efficient and comfortable swab and can bypass short-term shortages during times when timing is crucial.”
The swabs, designed by GobiX during the first Swiss COVID-19 outbreak in Ticino, Switzerland, and clinically-tested by a team of ten doctors and medical laboratory analysts for collection efficiency, testing ease, and patient comfort, are CE-certified as a Medical class I device and in full production. GobiX GmbH produces and packages the swabs for distribution among test locations across the country.
Adrian Härri, CEO, Biolytix AG, said, “Today, the key to fighting COVID-19 is simply identifying those who are infected as early as possible. This is the motivation behind our collaboration with GobiX and Formlabs – we are teaming to address the critical need for tools and equipment needed to safely collect and transport viral samples. One of the big challenges is getting the test samples to the analysis facility, without the risks involved of transporting a pathogenic virus. Our sample collection fluid deactivates the virus upon contact, preserves the viral RNA for up to four days and does not require cooled transportation – greatly facilitating testing in remote locations and the safety of anybody involved. Additionally, comparative tests have shown that the 3D printed swabs yield a higher amount of RNA, compared to its traditional counterparts, significantly improving the accuracy of the real-time PCR tests. We are extremely proud that our solution will contribute to accurate testing during this global crisis.”
Stefan Holländer, General Manager of Formlabs EMEA, explained, ““A single Form 3B printer can produce hundreds of swabs a day using our Surgical Guide resin, a certified biocompatible Class 1 material. The Form 3B printer enables fast, localized production of critical tools needed to support healthcare workers on the frontline of the COVID-19 pandemic. We are delighted that 3D printed swabs by GobiX GmbH in Switzerland have now become a segue to expand COVID-19 testing to save lives in hard-hit areas, around the world, quickly and economically.”
GobiX GmbH is now spearheading a partnership with Inqaba Biotechnical Industries (Pty) Ltd to distribute swab production systems throughout sub-Saharan Africa. Dr Oliver Preisig, Executive Director of Inqaba Biotechnical Industries (Pty) Ltd, explained, “All of the African continent is impacted by the shortage of COVID-19 test components, compounded by border closing. We have a unique ability to make widespread testing possible throughout Africa thanks to this strategic partnership with GobiX GmbH for the swab production systems and our own infrastructure with offices in Ghana, Nigeria, Kenya, Senegal and Tanzania and staff in Namibia, Uganda, Cameroon, Mali and Zimbabwe. This unique network for a life science company is currently essential to support the COVID-19 testing efforts in sub-Saharan Africa as we have team members in each of these countries. We are poised to implement the swab production system immediately and without delay, get people tested and help control the pandemic.”
Prof. Patricia Schlagenhauf, Co-Director of the WHO Collaborating Centre for Travellers’ Health, at the University of Zurich (UZH) and COVID-19 research collaborator with GobiX co-founder M. Bielecki, said “Having access to tests and test kits is so important especially in resource limited, vulnerable countries. Without tests, developing countries will not be able to monitor and control the spread of COVID-19.”