Helio Diagnostics: A Leader in In Vitro Diagnostics
Helio Diagnostics:
Your dedicated European partner for In Vitro Diagnostics.
With over 25 years of experience, Helio Diagnostics specializes in the development and manufacturing of advanced diagnostic devices. This robust team prides itself on delivering top-notch services to clients in the rapidly evolving In Vitro Diagnostics (IVD) sector.
About Helio Diagnostics
Helio Diagnostics, led by CEO Stéphane Debono, combines extensive industry experience with a visionary approach to In Vitro Diagnostics. The Board of Directors incorporates respected figures such as Corinne Danan, Philippe Dhamelincourt, Vincent Fert, and Fabienne Hermitte, all committed to in-depth technical expertise and operational agility.
Our Vision
Stéphane Debono emphasizes Helio Diagnostics' mission as becoming a leading reference in European IVD outsourcing: “The diagnostic industry is evolving quickly, necessitating partners who blend technical strength with operational efficiency. With our unwavering focus on IVD, we are poised to be the go-to partner for top-tier diagnostic companies globally.”
Trusted Partnerships
Helio Diagnostics has fostered strong relationships with major diagnostic brands, illustrating its reliability as a manufacturing partner:
“Helio Diagnostics is an indispensable ally for our Ipsogen RUO and IVD products, consistently providing reliable manufacturing and technical support. Their expertise in technology transfer and lifecycle management has been invaluable for our IVD-R product registrations.” - Thierry Bernard, CEO at QIAGEN.
“We chose Helio Diagnostics for the ongoing supply of our Prosigna IVD nCounter test. Their previous work impressed us, and we trust them to support our customers outside the US.” – Marc Stapley, Veracyte’s CEO.
Exploring Market Opportunities
The global IVD outsourcing market, valued at $13 billion, is projected to grow annually by 7.5%. Despite this growth, the landscape remains fragmented, with only a handful of specialized end-to-end Contract Development and Manufacturing Organizations (CDMOs) available.
Helio Diagnostics aims to bridge this gap, positioning itself as the preferred European partner dedicated entirely to IVD. With a capable team and seamless “plug-and-play” integration, Helio Diagnostics is delivering tailored solutions that leading diagnostic companies rely on.
Our Comprehensive Services
From concept through to commercialization, Helio Diagnostics takes a holistic approach to the full IVD lifecycle:
- Feasibility & Development: Focused on assay design, development studies, and pilot production.
- Performance Verification: Engaging in analytical and clinical validations.
- Industrialization and Tech Transfer: Ensuring effective scale-up, process verification, and validation.
- Quality Assurance & Regulatory Affairs: Upholding ISO 13485 and regulatory compliance with CE-marking and global submissions.
- Manufacturing & Logistics: Overseeing kit production, implementing cold chain management, and facilitating worldwide shipping.
- Lifecycle Management: Conducting post-launch monitoring and continuous improvement efforts.
With a strong emphasis on flexibility and operational excellence, Helio Diagnostics aims to empower innovating diagnostic leaders in oncology and infectious diseases, among other fields. The seasoned team leverages their collective expertise to help partners navigate the complexities of technical and regulatory challenges, thus speeding up time to market and ensuring compliant solutions.
Our Mission
At Helio Diagnostics, we are dedicated to being the reliable European partner for diagnostic enterprises. Our focus is on accelerating innovation, optimizing efficiency, and driving global success in the diagnostics arena.
Contact Us
For any inquiries:
Stephane Debono, President and CEO
stephane.debono@heliodiag.com
Marie Puvieux, Press Officer
Contact Number: +33 6 10 54 36 72
heliodiag@atcg-partners.com
Frequently Asked Questions
What is Helio Diagnostics known for?
Helio Diagnostics is known for its expertise in contract development and manufacturing services specifically for In Vitro Diagnostics.
Who leads Helio Diagnostics?
The company is led by CEO Stéphane Debono and governed by a diverse Board of Directors with extensive industry experience.
What types of solutions does Helio Diagnostics provide?
They offer development and validation, regulatory support, scalable manufacturing, global logistics, and lifecycle management.
Which companies partner with Helio Diagnostics?
Helio Diagnostics partners with leading diagnostic companies, including QIAGEN and Veracyte.
What is the mission of Helio Diagnostics?
The mission of Helio Diagnostics is to accelerate innovation and provide flexible solutions to diagnostics companies worldwide.
