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.
FDA-cleared
GENESEEQPRIME® NGS Tumor Profiling Assay (FFPE)
425-gene panel, TMB, MSI,ERBB2 amplifications, andALK/ROS1/RET/NTRK1 translocationsFor all solid tumors
Please refer to the Instructions for Use (IFU) for the intended use.
CE-IVD Approved
GENESEEQPRIME™
GENESEEQ PRIME NGS Tumor Gene Detection Kit
437-gene panel, TMB, MSIFor all solid tumors
GENESEEQPRIME™ HRD
GENESEEQ HRD (Homologous Recombination Deficiency) Detection Kit
Genome-wide HRD score437-gene panel, TMB, MSIFor all solid tumors
HEMASALUS™
GENESEEQ Blood Cancer Gene Detection Kit
475 gene at DNA level232 fusion genes at RNA levelFor all hematologic malignancies
SHIELDING ULTRA™
Geneseeq Multi-Cancer Minimal Residual Disease Detection Kit
A full-course perioperative MRD monitoring 2365 cancer-related genes for solid tumors
CANSCAN™
Geneseeq Multi-Cancer Early Detection Kit
Multi-cancer early detection (MCED)Assess multi-omics features of cfDNA through blood test
NMPA Approved
ESSENCARE™ CDx
EGFR/ALK/ROS1/BRAF/KRAS/HER2 Gene Mutation Detection 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 Detection 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
PANTRKARE™
NGS-Based NTRK1/2/3 Gene Fusion Detection Kit
China’s first NMPA-approved NGS-based pan-solid tumor companion diagnostic:
- Supports three NMPA-approved CDx applications for TRK-targeted therapies in China:
- ROZLYTREK® (entrectinib), with Roche
- AUGTYRO™ (repotrectinib), with Zai Lab
- VELMARTO® (eratrectinib), with Vcare PharmaTech
- Helps identify patients with NTRK fusion-positive solid tumors who may be eligible for matched TRK-targeted therapies
- Clinically validated in a multicenter study involving more than 2,400 clinical samples across 33 tumor types, with more than 200 unique NTRK fusion variants identified
WHO IS IT FOR
Solid tumor patients being evaluated for NTRK fusion-positive targeted therapy
SAMPLE TYPES
FFPE Tumor tissue
LET’S ACCELERATE PRECISION CANCER CARE, TOGETHER.
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