- The FDA approved Thermo Fisher Scientific Inc’s TMO Oncomine Dx Target Test as a companion diagnostic (CDx) to select patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and thyroid cancer who may be eligible for Eli Lilly And Co’s LLY Retevmo (selpercatinib) treatment.
- Related: FDA Approves Lilly’s Retevmo, the First and Only RET Inhibitor For Solid Tumor Indications.
- This marks the Oncomine Dx Target Test’s first approval as a CDx for a therapy targeting RET-positive thyroid cancer and the second approval associated with RET-positive NSCLC.
- The Oncomine Dx Target test is a next-generation sequencing-based test that can detect multiple alterations at once from a small sample size.
- 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.
- Price Action: TMO shares closed lower by 1.10% at $508.66 on Tuesday.
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