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
Tumor tissue (FFPE block/slides, or frozen tissue)
Essencare™ Report
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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.
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Other biomarkers tested
GENE NAME |
MUTATIONS |
EGFR |
G719 mutations, L861Q |
BRAF |
V600E |
KRAS |
G12 and G13 mutations |
HER2 |
exon20 insertions |
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.