GaDia SA is a Swiss Company developing new rapid Point-of-care predictive diagnostic tests for the detection and differentiation of healthcare-acquired infections. They are specialized in rapid tests for infectious diseases. GaDia’s mission is to help physicians to reduce the mortality of healthcare-acquired infections by providing accurate and relevant rapid diagnostic tests.
Guided Solutions were able to connect with Percevent Ducrest, CEO & Founder of GaDia to catch a sneak peek of what the industry can expect from the innovative start-up over the next year and dive into how GaDia is innovating to solve some major shortcomings in the Diagnostic rapid test space.
Please tell us more about you?
My name is Percevent Ducrest and I am the CEO and co-founder of GaDia SA. I studied Life Sciences with a Microbiology focus and am also an international Tennis Umpire. As such, I have had the chance to officiate in various international tournaments including the Australian Open and Wimbledon.
Tell us about GaDia?
GaDia SA is a Swiss start-up founded in 2019, focused on developing rapid diagnostic tests in the field of infectious diseases and nosocomial diseases.
Our areas of expertise are fungal, bacterial and viral infections as well as antimicrobial resistance. Our objective is to give healthcare professionals the easy and right tool to diagnose and treat quickly life-threatening diseases.
We have actually in our pipeline several tests for fungal infection (Candida and Aspergillus infections), bacterial infections (bacterial sepsis rapid test), viral infections (COVID rapid test 100% Swiss Made) and antimicrobial resistance rapid test (under development)
How did you come up with the idea? How was the technology first developed?
The idea and the technology were developed during my master thesis. Subsequently, I received a grant from a Swiss innovation foundation to continue the development of the product.
What differentiates your device to other technology on the market (if any)?
Our test is patented and uses the well-known Lateral Flow Technology, the same technology used for pregnancy rapid tests or COVID tests.
GaDia innovation is the combination of newly targeted and patented biomarkers specific to fungal infections. The test is performed at the patient bed (Point of care), is easy to use and rapid (15 minutes), reducing the risk of wrong interpretation. Moreover, the science used allows GaDia to predictively detect the fungal infections 2-4 days before it reaches the systemic stage (Bloodstream Infection or sepsis), therefore reducing mortality.
How has the company been funded till now? Can you tell us about your main investors?
We received a grant from The Ark Foundation in 2018 to continue the assay development initiated in my studies. In 2019, 2 C-level partners holding Bachelor and Master degrees in Finance and Management joined GaDia, bringing wide expertise in corporate management positions in pharmaceutical and medical device businesses in Switzerland and abroad. We are currently looking for more investors to grow our business.
What regulatory milestones have you achieved to date and when do you expect full market approval?
Our ISO13485 QMS is complete and we are waiting for a formal ISO13485 audit by BSI.
What is your Regulatory strategy?
Our ISO13485 certification is expected beginning of 2022 by the IVDR approved certified/notified body BSI. We would like to work with the same certified/notified body for the ISO13485 audit and CE marking under the new IVDR
Then, the product will be ready for launch (end of 2022), CE making will be applied after the audit of BSI notified body (under the new IVDR)
What have been the most notable challenges you have faced?
Developing a product to market stage is not without its challenges. I would say that so far the challenges I have faced have been in relation to the new IVDR, our studies being delayed due to COVID and of course, successfully completing the funding round.
Looking back is there anything you would have done differently?
I would say that if I could go back in time, I would have started the funding round much earlier.
Based on your experience as a founder, what advice would you give to other MedTech entrepreneurs that might be starting on this same journey?
It is important to have the right team around you in place – build a strong team and healthy team spirit. The right team is important for the progress but also as support thought the difficult moments.
Another important aspect is the regulatory one – do not forget about it! And of course – work faster on your product.
What are the next major milestones that are on the horizon for the next 24 months?
We are entering very exciting times with a few major milestones for GaDia SA:
- Q1-2022: ISO13485 audit and certification
- 2022: Clinical study on CandiDia rapid fungal test
- Q4-2022: CE marking and launch of CandiDia rapid fungal test
- 2021-2022: close the Serie A funding round
