Companion Diagnostic Test

COMPANION DIAGNOSTIC TEST

Companion diagnostic (CDx) tests are in vitro diagnostic (IVD) devices used in parallel to a therapeutic product, such as targeted therapy for cancer patients, to determine and guide its applicability.

Our extensive NGS-based CDx test development and first-in-class kit manufacturing facilities make us an excellent partner in accelerating the commercialization of your therapeutic product.

ESSENCARE®

EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit

Reversible terminator sequencing

  • NGS-based test approved by Chinese National Medical Products Administration (NMPA)
  • Ultra-high analytical sensitivities:
    • 1% for substitutions (SNPs) and insertion/deletions (indels)
    • 2.5% for gene rearrangements (fusions)

WHO IS IT FOR

Non-small cell lung cancer (NSCLC) patients seeking targeted therapy

SAMPLE TYPES
Icon Tumour Tissue

Tumor tissue (FFPE block/slides, or frozen tissue)

Essencare® Report

  • Companion diagnostic test for targeted therapy

BIOMARKER
NMPA-APPROVED THERAPY*
EGFR exon 19 deletion & EGFR L858R
Iressa® (gefitinib), Conmana® (Icotinib)
EGFR T790M
Tagrisso® (osimertinib)
ALK rearrangements
Xalkori® (crizotinib)
ROS1 rearrangements
Xalkori® (crizotinib)

*Iressa® and Tagrisso® are registered trademarks of the AstraZeneca group of companies. Xalkori® is a registered trademark of Pfizer Inc. Conmana® is a registered trademark of Betta Pharmaceuticals.

  • Other biomarkers tested

GENE NAME
MUTATIONS
EGFR
G719 mutations, L861Q
BRAF
V600E
KRAS
G12 and G13 mutations
HER2
exon20 insertions

Contact us today to learn more about Essencare®

LET’S ACCELERATE PRECISION CANCER CARE, TOGETHER.

Learn more about our products and services or contact us today to discuss how we can partner together.

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