gMendel® is a MedTech Companion Diagnostics as a Service company for genetic disorders & beyond. gMendel® has developed an AI cloud-based end-to-end IVD certified technology for accurate, fast & affordable diagnosis. Moreover, gMendel®’s technology is automated, transcending the need for bioinformatician ‘s intervention, reducing the experimental errors & costs. This improves accessibility and has a potential to revolutionize genetic analysis without changes to current health care protocols.
Research & Technology
We achieved Proof of Concept for deletions, insertions, point mutations, whole exome seq. & DNA region customisation with amplicon & probe, and enhanced Phivea® platform, a comprehensive decision support software for healthcare professionals. To analyze different gene sequences, we developed the machine learning algorithm Torchlex. Torchlex reduces computational complexity and significantly increases the speed of analysis, while maintaining the same quality and accuracy compared to Next Generation Sequencing. This method allows us to significantly reduce the cost and speed of analysis per gene sample. Throughout the year, we actively explored various options, carefully evaluating factors such as scalability, security, ease of integration, and compatibility with existing healthcare systems in our pursuit of the highest levels of data security. This has led to significant progress in adopting blockchain technology within our Phivea® platform. We’re pleased to share that we’ve laid a strong foundation and evaluated potential solutions. We are ready to take the next step by implementing the first use case, using smart contracts to securely record proofs of data existence in the form of hashes on the blockchain.
Quality management system & Intellectual Property
We maintained our ISO13485 certification within the scope “Design and Development and Service Provision of In Vitro Diagnostic Medical device software”. We worked intensively to continue meeting the regulatory requirements for our Quality Management System.
Our first patent was published on Dec 7 (WO2023/232940 A1; PCT/ EP2023/064684)
International Collaborations & Partnerships
We continued our strategic partnerships with Netcetera AG (Software Development CO, CH); Star Global (QA/RA); GenXone S.A. (DNA Seq. Lab, PL); Oxford Nanopore Tech (Biotech Co, UK), and established a new partnership with Agilent Technologies (US). We have also strong collaborations with: Univ. of Copenhagen, DK; National Centre for Scientific Research ”Demokritos”, GR; Univ. of Ss. Cyril & Methodius in MK; Coriell Institute for Medical Research, USA.
Board of Directors
We strengthened our Board of Directors with two new members. Our board now consist of Hanna Pyokari (co-founder, focus on Financial Planning & Budgeting), Dr. Zoran Zdraveski (focus on Strategy & IPR) and Prof. Deepak Asudani (focus on Health Systems & US expansion). The Board continuous to guide the company forward, especially through shaping public private partnerships, a key factor in unlocking the potential of the gMendel® technology for mass screening of genetic disorders & beyond.
Funding
In 2023, we raised funding from public and private institutions such as a) Innovation Fund Denmark (project concluded successfully in May 2023); b) EU Eureka Eurostars (project is ongoing until March 2025); c) EU Eureka Innowwide (project concluded successfully in Nov 2023) as well as the Danish angel investors iFutura, Quaternity and CVX ventures.
Key customers
We have signed cooperation agreements with hospitals, distributors and public bodies across Europe, North America, South America and Middle East and we are ready to start pilots for Companion Diagnostics for Spinal Muscular Atrophy (SMA), Cystic Fibrosis (CF), Anemia and Epilepsy.
Publications, Participation in Conferences & other Events
In November, we submitted our first paper to Nature Group: Schack, A. et al, SCAN: a nanopore-based, cost effective decision-supporting tool for mass screening of aneuploidies.During the year, our team has actively participated in numerous conferences, delegations and meetings across the world, from the U.S. to Japan, with the aim to inform patients, scientists, healthcare professionals and regulators about the gMendel® technology and its benefits for early and accurate diagnosis. All our publications, posters, abstracts are published on the gMendel® website: https://www.g-mendel.com/PUBLICATIONS/.
Communication with Funding Institutions
Social Media
LinkedIn:100+ announcements on LinkedIn and approx. 2,700 followers.
Our strategic commitments for 2024
Commitment #1: Start commercialization of our Companion Diagnostics as a Service (CDxaaS) in Europe, North America, South America and Middle East. 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. After successful pilots we will start generating revenues (Q4 2024)
Commitment #2: Continue building interconnected partnerships with public health systems, industry, KOLs and communities. We expect to enhance our current collaborations and partnerships and initiate new ones in selected countries. We also expect to participate in more conferences and congresses and be active members of more advocacy groups.
Commitment #3: PoC for cfDNA and experimentation with multi-omics & clinical data.
Commitment #4: Blockchain technology for highest security & reliability. First use case, using smart contracts to securely record proofs of data existence in the form of hashes on the blockchain.
Commitment #5: Expand our IP with additional patents and publications.
Commitment #6: Close our seed funding round (Q1 2024) and raise additional grants.
Thanks for your continuous support! Together, we are building tomorrow’s healthcare for genetic disorders/rare diseases towards precision treatments.
HAPPY NEW YEAR 2024!
gMendel® Executive Management