Thermo Fisher's Oncomine Dx Test Is First FDA Approved NGS-Based Companion Diagnostic To Detect Thyroid Cancers

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.