Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers

Approval also marks the second NGS-based companion diagnostic to identify RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC)

The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly’s Retevmo (selpercatinib). This marks the Oncomine Dx Target Test’s first approval as a CDx for a therapy targeting RET-positive thyroid cancer and second approval associated with RET-positive NSCLC.

Initially approved in 2020, Retevmo is a selective RET kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. RET (rearranged during transfection) alterations are found in approximately 2% of patients with NSCLC, which is the leading cause of adult cancer death in the United Statesⁱ, 60% of patients with MTC and 20% in other thyroid cancers.ⁱⁱ

The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, helping to quickly match patients with the appropriate targeted therapy. It is also approved in Japan as a companion diagnostic for Retevmo in the same indications. The test is the only globally distributable NGS CDx solution that has received regulatory approval in 17 countries for 15 targeted therapies, covering more than 550 million lives globally.

Garret Hampton, president, clinical next generation sequencing and oncology at Thermo Fisher Scientific in his statement regarding the approval said, “Following the Oncomine Dx Target Test’s first approval in 2017, we have worked to advance access to companion diagnostics for targeted therapies on a global scale.” He also added, “As we continue to pursue additional approvals alongside our biopharma partners, we remain committed to broadening access to NGS-based testing to ensure patients and clinicians everywhere can benefit from it.”

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 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.

ⁱ https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html

ⁱⁱ https://www.cell.com/trends/cancer/fulltext/S2405-8033(21)00148-5

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