IVD-CDx platform

본문 바로가기

IVD-CDx platform

In vitro companion diagnostics (IVD-CDx) involves biomarker-based in vitro devices that are intended to assist physicians in the identification of patient populations that may potentially benefit from a specific treatment.

We have established technologies to develop IVD-CDx system for our drug pipelines and set up the FDA approved IVD-CDx platforms based on immunohistochemistry and molecular genetics analysis technologies with automated systems.

[References] In vitro Companion Diagnostic Devices 'Guidance for industry and FDA staff' Document issued on August 6, 2014
Ventana systems for Herceptin
  • Inform HER-2/NEU
  • Inform HER2 Dual ISH DNA Probe Cocktail
  • Pathway Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody
cobas® Oncology biomarker tests
  • Real-Time PCR detects the presence of mutations in cancer genes
Roche cobas® z480 analyzer
  • cobas® BRAF Mutation Test (IVD-CDx) for Zelboraf®
  • cobas® EGFR Mutation Test (IVD-CDx) for Tarceva®
Therascreen Oncology biomarker tests
  • QIAGEN therascreen® EGFR RGQ PCR kit for Gilotrif ®
  • QIAGEN therascreen® KRAS RGQ PCR kit for Erbitux ® and Vectibix®
Droplet digital PCR Oncology biomarker tests
  • Bio-Rad QX200 Droplet Digital PCR
  • QuantaSoft™ Version 1.6.6
NGS Oncology biomarker tests by Ion Proton system
  • Exome sequencing
  • RNA sequencing
  • Targeted sequencing
Roche cobas® z480 analyzer
  • cobas® KRAS Mutation Test (IVD)