We are excited to share that GenDx updated its website to better showcase our comprehensive Companion Diagnostics (CDx) services. Our goal is to support partners in the pharmaceutical and biotech industries through State-of-the-Art NGS-based diagnostics and support the journey from initial concept to clinical implementation. Find our updated pages here and learn everything about what we have to offer for you.
What is a CDx?
A CDx is a specialized in vitro diagnostic device that provides information critical for the safe and effective use of a corresponding pharmaceutical therapy.
Many modern precision medicine treatments are tailored towards specific biomarkers or a unique genetic profile of the disease and/or patient. A patient’s eligibility or susceptibility to such a treatment therefore depends on their genetic profile or the presence/absence of specific biomarkers. A CDx can act as the key to unlock this patient specific information, ensuring that the right therapy is matched with the right patient at the right time.
Why is CDx important?
With the advances of Precision Medicine, therapies continue to move from a “one-size-fits-all” to a more personalized approach. For the success of such approaches, a CDx is vital for several reasons:
- Patient Identification: A CDx can identify the specific individuals most likely to benefit from a particular therapy, improving overall success rates.
- Risk Stratification: By screening for genetic markers, a CDx can identify patients at an increased risk for serious adverse reactions, significantly enhancing safety.
- (US specific) Therapy Monitoring: It allows clinicians to monitor treatment responses, enabling them to optimize dosage and efficacy throughout the patient’s journey.
- Regulatory Success: For many new precision therapies, having a validated CDx is a requirement for regulatory approval, ensuring that the drug is used exactly as intended.
What can GenDx offer?
As GenDx, we can be your partner from start to finish in the CDx space. We understand the challenges of co-developing a CDx alongside the development of new precision medicine therapies. We offer a client-first approach, in combination with cutting-edge technology and deep regulatory expertise, specifically for complex and polymorphic genes like HLA, KIR, and MICA/MICB.
Here is how we support your therapeutic strategy:
- End-to-End Expertise: We handle everything in-house—from initial R&D and assay development to manufacturing and market access.
- Proven Regulatory Experience: We were the first in the transplantation field to attain IVDR certification for our HLA typing reagents and software. We offer proven support for both European and USA (FDA) approvals.
- Rapid Development Timelines: Depending on your requirements, we can move from a CE-marked legacy device to a tailor-made clinical performance study assay in as little as 6–9 months.
- Best-in-Class Software: Our NGSengine software is world-renowned for its accuracy in analyzing NGS-based HLA typing, providing the reliable data needed for complex clinical decisions.
- Flexible & Collaborative Approach: Whether you need help with bridging studies, interventional studies, or global registration, our dedicated project teams work closely with you to meet your specific requirements.
Ready to accelerate your precision medicine project with us? Explore our updated Companion Diagnostics page to learn more about our solutions, our portfolio; spanning applications for NGS, Sanger sequencing, and qPCR/dPCR, and see how we can help you turn your therapy into a clinical reality.
