Companion Diagnostics
The use of companion diagnostic device to detect the status of biomarkers in subjects' biological samples can provide important information for the safety and effectiveness of drug use, including helping to screen out specific populations that benefit from a certain type of drug treatment, identify specific populations at increased risk of serious adverse reactions to a certain type of drug treatment, and adjust doses to improve the safety or effectiveness of a certain type of drug.
Your companion diagnostic path may be:
1. Confirm that the marketed in vitro diagnostic device (IVD) can be used as companion diagnostic device;
2. Codevelopment of IVD companion diagnostics and therapeutic products, and take the data of joint research of drugs and companion diagnostic devices as supporting evidence for the listing of both;
3. Use clinical trial analysis method (Clinical Trial Assay, "CTA") for biomarker analysis of cases in drug clinical trials, and the corresponding companion diagnostic devices are relatively lagging behind, and then take the bridge test data to prove the equivalence of companion diagnostic device and key clinical trial CTA as supporting evidence for the listing.
KingMyLab Solution
For pathway 1, we use the marketed IVD companion diagnostics and complete the verification in the central laboratory, and have provided sample testings for multiple clinical trials. The platforms involved are immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), fluorescence quantitative PCR (qPCR), next-generation sequencing NGS, etc., and the companion diagnostic markers include PD-L1, HER2, ALK, EGFR, etc.
For pathways 2 and 3, for drug clinical trials with the development of companion diagnostic devices, we recommend to cooperate with our scientific team as soon as possible and plan the development of companion diagnostics as soon as possible. If there are sufficient basic research data to support the biomarkers but without clinical validation in the early stage, considering the risk of clinical trials, the development time and cost of the companion diagnostic devices, we suggest to consider using KingMylab's strong translational medicine ability to quickly establish the laboratory self-developed test (LDT) to support early clinical trials. According to the results of the study of biomarkers in early clinical trials, will help the decision making on whether to use a certain biomarker for population enrichment. We have rich LDT experiences and have completed the development and validation of hundreds of biomarker LDTs on different technology platforms.
Once the development of companion diagnostic device is confirmed, we will integrate the powerful IVD partner resources in the KingMed ecosystem, draw on each other's strengths, co-create the ecology, and work closely with the sponsor and IVD partner. Based on the progress requirements of clinical trials, the companion diagnostic device will be developed by the IVD partners and validated and capacity trained in our central laboratory, while the companion diagnostic laboratory tests will be carried out.
After the companion diagnostic devices and drugs are launched, we can rely on the leading independent clinical laboratory service capacity of KingMed Diagnostics to help the companion diagnostics quickly meet clinical needs.
