Chinese FDA Approves Novogene CDx Test for NSCLC Therapies

NEW YORK (GenomeWeb) – Tianjin Novogene Bioinformatics Technology announced today that the Chinese Food and Drug Administration has approved the firm’s NovoFocus NSCLC CDx assay.

The next-generation sequencing-based diagnostic test simultaneously analyzes tumor samples for multiple genomic mutations that are targeted by several CDFA-approved therapies for non-small cell lung cancer, including Iressa (gefitinib), Tagrisso (osimertinib), and Xalkori (crizotinib).

Following the CDFA approval, researchers can use the test to identify NSCLC patients who may respond to the targeted therapies.

Beijing-based Tianjin Novogene Bioinformatics Technology is a subsidiary of Novogene. In June, Novogene’s Singapore-based subsidiary NovogeneAIT inked a deal with Lucence to develop NGS-based tests for precision cancer treatment for the Asian market. In May, Novogene received CLIA certification for its US clinical laboratory, which provides customers with whole-genome sequencing services.

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