A companion diagnostic (CDx) is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.

Companion diagnostics can:

• identify patients who are most likely to benefitfrom a particular therapeutic product;
• identify patients likely to be at increased risk forserious side effects as a result of treatment with a particulartherapeutic product; or
• monitor response to treatment with a particulartherapeutic product for the purpose of adjusting treatment to achieveimproved safety or effectiveness.[1]

Up to now，FDA has approved 49 CDx kits, including PD-L1/BCR-ABL/MMR/MSI,etc biomarkers^[2]. MEDx is a leading innovative company in companion diagnostics and can provide total solution provider for precision medicine in China.

Taking advantage of the comprehensive translational platforms including genomics, proteomics, cytomics, and pathology, MEDx offers our customers the integrated solutions from biomarker discovery, target validation, molecular testing, and patient stratification for drug clinical trials, to the IVD/CDx R&D and commercialization. With a world-class technical team and a rich IVD/CDx pipeline, MEDx collaborates with hundreds of world-renowned pharmaceutical companies.

MEDx built up the high  quality system and the world’s leading StarLIMS system used for laboratory information management and has been rewarded with many certifications China CNAS, ISO17025, and US CAP ISO 13485 etc. MEDx is also the founding member of China Precision Medicine and Companion Diagnosis Committeeunder the Chinese Society of Biotechnology

【1】  https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics

【2】  https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools