Thermo Fisher’s NGS assay receives FDA approval

The U.S Food and Drug Administration (FDA; MD, USA) has approved Thermo Fisher Scientific’s (MA, USA) next-generation sequencing (NGS) assay as a companion diagnostic for ZEGFROVY and for tumor profiling.

The FDA approved the Oncomine^TM Dx Express Test on the Ion Torrent^TM Genexus^TM Dx Integrated Sequencer as an in vitro diagnostic assay for use as a companion diagnostic (CDx) for Dizal Pharmaceutical’s (Shanghai, China) ZEGFROVY (sunvozertinib), a medication used to treat non-small cell lung cancer, and in tumor profiling. The Oncomine Dx Express Test is able to deliver essential genomic insights in as little as 24 hours, bringing rapid NGS to decentralized clinical trials and enhancing the accessibility of precision oncology tools.

A patient’s tumor profile can guide precision oncology care, but delays in obtaining results can hinder clinicians’ ability to use this information to inform decisions, potentially meaning some patients miss out on targeted therapies. Inefficiencies or lack of access to testing also prevent some patients from accessing personalized care, highlighting the need for timely genomic profiling.

“NGS has been instrumental in advancing precision oncology, but these insights often aren’t available early enough to inform real-world care,” said Kathy Davy, President of clinical next-generation sequencing at Thermo Fisher Scientific.

The Oncomine Dx Express Test is intended for use as a CDx for ZEGFROVY to identify patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations. The test has also been approved for tumor profiling in solid tumors. The Genexus Dx Integrated Sequencer automates the NGS workflow, including sample preparation all the way to data analysis and reporting, making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results and tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology.

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“With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment. We’ve been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey, bringing rapid, decentralized NGS CDx to drug development. We are proud of our collaboration with Dizal to bring ZEGFROVY to the US market.”