IN VITRO DIAGNOSTICS
In vitro diagnostics (IVD) are tests conducted on human samples, which may be used in precision medicine to determine and guide the applicability of targeted therapy, immunotherapy or other drug treatment for cancer patients.
Our extensive NGS-based IVD tests development and first-in-class kit manufacturing facilities make us an excellent partner in accelerating the commercialization of your therapeutic product.
ESSENCARE™ CDx
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
FFPE Tumor 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 |
GENESEEQPRIME™ TMB
Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit
Reversible terminator sequencing
- NGS-based test approved by Chinese National Medical Products Administration (NMPA)
- An overall concordance rate of over 90% compared to the gold standard WES-TMB
- Limit of detection has been demonstrated to be at 2% VAF for various common variant types or 5% tumor cell content in the reference samples
WHO IS IT FOR
Non-small cell lung cancer (NSCLC) patients seeking immune checkpoint inhibitor therapy
SAMPLE TYPES
FFPE Tumor tissue
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.