Fuelled in large part by the coronavirus pandemic, 2021 brought new challenges no one was prepared for, changing the way we live, we act and how we connect with each other. For us, the gMendel team, 2021 was as demanding as it was defining.
Research and development
Our R&D activity has been in full swing all year around, in view of the commercial launch of the first version of Phivea™Platform. We have done many tests with healthy and chromosomal aberration positive samples to optimise our technology. In November, we received more than 10,000 samples (DNA in tube) from Coriell Institute for Medical Research and our R&D Lab is currently fully occupied with the verification and subsequent validation of our technology.
We presented part of our research in 4 important congresses, the ASHG (American Society for Human Genetics), the Sanford Research Rare Disease Summit, NORD – Rare Diseases and Orphan Drugs Breakthrough Summit and the Nanopore Community Meeting.
Quality assurance
Following 4,5 months of intensive work, together with Star, our strategic partner in meeting regulatory requirements, we managed to finalise and fully document our Quality Management System, according to international standards, a truly major accomplishment, considering the short timeframe! Following this great milestone, we are now legally entitled to commercially launch the first version of our Phivea™Platform, the novel screening tool for the detection of 6 chromosomal aberrations, in the beginning of 2022.
Collaborations
We believe that all things can be reimagined, and that innovation emerges through collaboration. To further build on our AI-empowered technology, which we developed with Netcetera (our software technology partner), we started a new partnership with the ahedd Digital Innovation Hub of the NCSR Demokritos, Greece. Across the continent, we are about to start collaborations with one of the largest companies in the Brazilian diagnostics industry, as well as with the largest public and private hospitals. We are also about to start collaboration with a key healthcare industry player in the USA.
Networking and advocacy
We engaged with diverse networks and advocacy groups with the aim to contribute to actions and policies that lead to social, financial and environmental sustainability. At an international level, we joined leading networks EURORDIS, a non-governmental patient-driven alliance of patient organisations representing 984 rare disease patient organisations in 74 countries, and NORD, a patient advocacy organization with over 300 members dedicated to individuals with rare diseases. Locally, we joined Barcelona Health Hub, a non-profit association working to become a global reference for digital medicine, as well as the digital healthcare Master Class Programme, organized by The Trade Council of Denmark, a new initiative that aims to support Danish SMEs that wish to enter the Brazilian market, connecting them directly with partners, customers and key decision-makers.
Awards
In August, we were shortlisted as finalists at the Golden Egg start-up competition in Copenhagen. The Golden Egg competition awards the three most compelling start-up ideas and offers them a network and advice from industry people.
Brand identity
This was the year we developed our brand identity and visual communication in collaboration with g Design. During the first half of the year, we worked vigorously to launch our website and social media channels (LinkedIn, Twitter, YouTube), which are now the main tools we use to communicate about our technology and activities to our communities.
LOOKING AHEAD
To us, 2022 already presents a range of exciting opportunities to come. From leveraging robust technology for screening and diagnosis of genetic disorders to becoming a strong voice in influencing public policy for disease management, we are looking ahead filled with a sense of commitment to utilizing the expertise of our people, emphasizing our innovation capabilities and strongly engaging with international networks and advocacy groups that can bring change.
OUR STRATEGIC COMMITMENTS FOR 2022
Commitment #1
Continue building interconnected partnerships with industry and communities
We expect to enhance our current collaborations and partnerships and initiate new ones in many countries. We also expect to participate in more conferences and congresses and be active members of more advocacy groups.
Commitment #2
Continue extending our Phivea™ Platform from Q2/2022 onwards
After releasing our initial version of Phivea™Platform under the 98/79/EC In Vitro Diagnostic Medical Devices (IVD) directive, as we go forward, next versions of Phivea™Platform releases will be according to 2017/746 IVD regulation.
Commitment #3
Become ISO 13485-certified by Q1/2022
To this end, starting in January 2022, we will go through an external audit, which will be executed by Lloyd’s Register.
Commitment #4
Close our first funding round by Q2/2022
We will accelerate our efforts to close our first funding round by Q2 and also get grants through EU research and innovation programs.
Commitment #5
Start commercialization in some EU countries by Q3/2022
After registration and approval from the Danish regulatory authorities early 2022, we will continue registration and approval in more EU markets such as Greece, Poland and Spain. Next, we plan to start pilot projects within private/public hospitals and private diagnostic centers. Through these projects, we will be able to collect more data and receive invaluable customer input for our future products.
Commitment #6
Move to blockchain technology for highest security and patient data encryption in Q4/2022
Safe operations (privacy and proper interpretation of personal data), as well as commercial and technological innovation (machine learning and human expertise) are the cornerstones needed to deliver better value (sustainable impact) for health care professionals and people with rare diseases/genetic disorders (and their families). To this end, from Q4, we are moving from SHA hashing and RSA asymmetric key-based algorithms, to blockchains. Blockchain technology is decentralized, incorruptible, enabling highest security and patient data encryption.
We look forward to 2022!