GenDx, your trusted partner for Companion Diagnostics
We are proud to introduce our Companion Diagnostics (CDx) service, designed to revolutionize personalized medicine. The HLA typing of a patient can potentially predict the response of a patient to a particular therapeutic product (read more here). Including HLA typing as a Companion Diagnostic in clinical trials can significantly impact future patient care and treatment modalities. Decisions made during the initial stages of pharmacological clinical trials (Phase I or II) can significantly influence the design and documentation requirements of the Companion Diagnostic. At GenDx, we offer our cutting-edge technology and extensive expertise to aid in that process.
With Companion Diagnostics
Identify patients
who are most likely to benefit from a particular therapeutic product
Identify increased risk
of serious side effects as a result of treatment with a particular therapeutic product
Monitor response to treatment
with a particular therapeutic product to adjust treatment and achieve improved safety or effectiveness
What we offer
With our experience and expertise in the field, we can offer:
- Excellent state-of-the-art NGS based molecular diagnostics
- All HLA loci as single locus test or multiplexed together (including HLA-A, B, C, DRB1, DRB3/4/5, DQB1, DPB1, DQA, DPA1)
- CE marked Reagents and software devices under IVDR
- Regulatory proficiency with EU IVDR & FDA legislation
- Robust network of collaborators to facilitate clinical trials and CDx submissions
- Beyond HLA typing: KIR or MICA/MICB typing, screening for loss of heterozygosity and more