Thermo Fisher's Oncomine Dx Test Is First FDA Approved NGS-Based Companion Diagnostic To Detect Thyroid Cancers - Thermo Fisher Scientific (NYSE:TMO)

  • 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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