CE-Marked CDx kit solution for non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and gastrointestinal stromal tumor (GIST).

Detect gene mutations at the standard recommended (TierⅠ and tierⅡ variants) by clinical guidelines, including all the EMA/FDA/NMPA-approved targeted therapy.

With a starting material requirement as low as 30ng, our kits are suitable for small samples such as those obtained from needle biopsies.

Key Features and Benefits

● Efficient and Accurate Library Construction

Utilizing Single-Tube-Hybridization, Anti-Contamination-Adapter, and Dual-End-Barcode techniques, the kit ensures rapid and simplified operation, minimizing the risk of contamination while maximizing conversion efficiency.

● Intelligent and Efficient Data Analysis

OncoMaster, a comprehensive data analysis system, integrates a robust knowledge base and advanced patented algorithms along with high-performance analysis processes, enabling rapid and efficient data interpretation.

● Small in Size, Big on Performance

Despite its compact size of 53kb, the panel covers the vast majority of variants in tierⅠ and tierⅡ associated with lung cancer, colorectal cancer, and gastrointestinal stromal tumors.

● Excellent User Experience

The kit’s operation is straightforward and user-friendly, ensuring a seamless experience for all users. Equipped with the fully automated library preparation system, Nexus BR, NGS detection becomes even more convenient.

Performance Validations

Accuracy

117 clinical samples and commercial references With an accuracy of 100%,
no missed or false-positive mutations

Specificity

15 benign lung tissues and cell line samples
npa=100%

Biomarker Panels

EGFR

MET

ERBB2

ALK

BRAF

KRAS

ROS1

RET

PIK3CA

NRAS

HRAS

KIT

PDGFRA

Non-small cell lung cancer (NSCLC):

EGFR、ALK、ROS1、RET、MET、ERBB2、BRAF、PIK3CA、KRAS

Colorectal cancer (CRC):

BRAF、PIK3CA、KRAS、NRAS、HRAS

Gastrointestinal stromal tumor (GIST):

KIT、PDGFRA

Specifications

Certification

CE-IVD

Tests/Kit

48

Alteration detected

SNV, Indel, Fusion and CNV

Sample type

FFPE tissue

Sequencing Type

PE150

Sequencer

Illumina MiSeq