In an interaction with MedTech Spectrum, Jane Li, Senior Director of Pharma CDx and CRO Partnerships at Thermo Fisher Scientific, discussed the recent FDA approval of the Oncomine Dx Express Test. Designed as a next-generation sequencing (NGS)-based companion diagnostic, the test offers rapid and accurate detection of clinically significant mutations, including EGFR exon 20 insertions. This enables clinicians to identify non-small cell lung cancer (NSCLC) patients who may benefit from targeted therapies such as ZEGFROVY. Li noted that the approval marks a key advancement in making precision oncology more accessible, aligning with Thermo Fisher’s ongoing commitment to deliver fast, clinically actionable insights that personalise care and improve outcomes for cancer patients across diverse treatment settings.

How does the FDA approval of the Oncomine Dx Express Test as a companion diagnostic for ZEGFROVY take care for NSCLC patients with EGFR exon 20 insertion mutations?

The FDA approval of the Oncomine Dx Express Test advances patient care by enabling rapid and decentralised genomic testing to identify NSCLC patients with EGFR exon 20 insertion mutations who may benefit from sunvozertinib. Patients in this subgroup have historically had limited treatment options and complex diagnostic pathways that often required sending samples to large laboratories, resulting in long turnaround times.