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Novogene Receives CFDA Approval for NovoFocus NSCLC CDx Test

Novogene Receives CFDA Approval for NovoFocus NSCLC CDx Test

Beijing, China – August 15, 2018 –Tianjin Novogene Bioinformatics Technology Company LTD, a fully-owned subsidiary of Novogene Co., received CFDA approval for its NovoFocus NSCLC CDx Test today. This is a next-generation sequencing (NGS)-based diagnostic test that simultaneously analyzes tumor samples for multiple genomic mutations associated with several CFDA-approved targeted therapies for non-small cell lung cancer (NSCLC), which accounts for ~80% of all lung cancers in China.

The NovoFocus NSCLC CDx Test was developed on the Thermo Fisher Ion Proton™ sequencing platform (approved by CFDA as “DA8600” in January 2017 for the diagnosis of cancer and inherited diseases). The reagent kits for sample processing and library construction, as well as the data analysis and result reporting software system, were developed by Novogene. Following this CFDA approval, results from the sequencing and analysis of three genes, EGFR, ALK and ROS1, can be used to identify NSCLC patients who may be eligible for treatment by CFDA-approved targeted therapies Gefitinib (IRESSA®), Osimertinib (TAGRISSO®) and Crizotinib (XALKORI®), respectively. Results on the other three genes, KRAS, BRAF and PIK3CA, can be considered by clinicians together with other test results and the patient’s disease characteristics during clinical decision making.

Figure: CFDA announcement for the approval of the NovoFocus NSCLC CDx Test (red box: translated to English below)

Ion Proton™ is a registered trademark of Thermo Fisher; IRESSA® and TAGRISSO® are registered trademarks of AstraZeneca; and XALKORI® is a registered trademark of Pfizer.

About Novogene

Novogene is a leading provider of genomic services and solutions with cutting-edge NGS and bioinformatics expertise and the largest sequencing capacity in the world. Novogene utilizes scientific excellence, a commitment to customer service and unsurpassed data quality to help our clients realize their research goals in the rapidly evolving world of genomics. With 1,800 employees, multiple branches around the world, 49 NGS-related patents, as well as over 950 publications in top-tier journals such as Nature and Science, the company has rapidly become a world leader in NGS services. For more information, visit