FDA approves the first multi-biomarker NGS companion diagnostic kit
Companion diagnosis is an in vitro diagnostic technique associated with targeted drugs. It mainly selects the best drug users in different types of disease populations by detecting the expression levels of proteins and mutant genes in humans. Medical .
Concomitant diagnosis has become an indispensable tool for oncologists today. Analysts expect that the global companion diagnostic market will reach nearly $10 billion in three years.
There is growing evidence that cancer is a complex and diverse disease, patients may exhibit similar symptoms and have the same pathological changes, which may be caused by completely different genetic changes. Because of this heterogeneity, cancer patients with the same pathological type have a very different response rate to currently available drugs. "The same disease, the same treatment plan" can not meet the patient's treatment needs, individualized medical treatment (same disease and treatment) has become the trend of the times.
FDA approves the first multi-biomarker NGS companion diagnostic kit
On June 23, the FDA approved the first companion diagnostic kit based on NGS technology that can analyze changes in response in three non-small cell lung cancer (NSCLC) treatments. This is the first FDA-approved screening for multiple markers. Tumor second generation gene sequencing detection.
It is reported that this product was developed by Thermo Fisher Scientific, Inc., under the product name Oncomine DX Target Test, which is used to screen BRAF, ROS1 and EGFR mutant second-generation gene sequencing tests for NSCLC patients.
In addition, the kit is based on Thermo Fisher's ion ampliseq technology and will be run on the PGM DX system. Sample processing is performed in accordance with FDA 510(k) guidelines for formalin-fixed paraffin embedding on tissue samples. Machine analysis.
This product can be used to identify AstraZeneca's EGFR inhibitor Iressa (gefitinib), Pfizer's ALK and ROS1 inhibitor Xalkori (crizotinib), and Novartis's MEK inhibitor Mekinist (trametinib) and inhibitor Tafinlar (dabrafenib) The best subject for these 4 drugs.
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