FDA Approves NGS-Based Companion Diagnostic for EGFR Exon20 Insertion Mutant Non-Small Cell Lung Cancer Tumor Tissue

CARLSBAD, Calif., Dec. 9, 2021 -- The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT^® (amivantamab-vmjw)*, Janssen Biotech, Inc.'s (Janssen's) targeted therapy.

"The FDA's approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the U.S. who may benefit from this important new therapy," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "In situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine. We look forward to expanding registration of the test as a companion diagnostic for RYBREVANT globally to help improve outcomes for more patients."

This is the second approval for Oncomine Dx Target Test as a CDx for EGFR Exon20 insertion mutant patients and the 12^th NSCLC global approval overall. The test is the first and only FDA-approved next-generation sequencing (NGS) CDx on formalin-fixed, paraffin-embedded (FFPE) tissue for determining RYBREVANT eligibility in patients whose disease has progressed on or after platinum-based chemotherapy. 

Lung cancer is the leading cause of cancer deaths worldwide.¹ EGFR mutations are an important therapeutic target in NSCLC; EGFR Exon20 insertion mutations, specifically, are associated with resistance to immune checkpoint inhibitor therapies and poor patient prognosis.² Further, EGFR Exon20 insertion mutations are often under-detected by conventional, single-gene testing methods.^4,5 This is driving the need for more comprehensive biomarker testing with NGS technology, which simultaneously interrogates multiple biomarkers for early identification and appropriate characterization of cancer patient samples.

Thermo Fisher's Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017, and it is now approved in the U.S. for six targeted therapies for NSCLC and one for cholangiocarcinoma. The test has also been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC. The test is the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries. This includes the U.S., multiple European nations, Japan, South Korea and the Middle East, covering more than 550 million lives globally.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

* For full RYBREVANT Prescribing Information, including Important Safety Information, visit www.rybrevant.com.

¹ https://www.who.int/news-room/fact-sheets/detail/cancer
² https://www.nature.com/articles/s41392-019-0038-9
⁴ Riess JW, Gandar DR, Frampton GM, et al. Diverse EGFR Exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. J Thorac Oncolo. 2018;13(10):1560-1568. 10.1016/j.jtho.2018.06.019.
⁵ Bauml JM, Viteri S, Minchom A, et al. Underdiagnosis of EGFR Exon 20 insertion mutation variants: estimates from NGS-based real-world datasets. Oral presentation presented at: International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer Singapore (WCLC 2020); January 28-31, 2021; Worldwide Virtual Event.