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Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA's Approval as a NGS-Based CDx for the Treatment of NSCLC

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Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA's Approval as a NGS-Based CDx for the Treatment of NSCLC

Shots:

  • The US FDA has approved Oncomine Dx Target Test as a CDx to identify EGFR exon 20 insertion mutations in patients with NSCLC who undergo treatment with amivantamab
  • The approval allows clinicians to use FFPE tissue samples to identify patients in the US. The test can assess 23 genes that are associated with NSCLC & are currently approved in 15+ countries including the US, EU, Japan, South Korea & Middle East
  • The approval marks 2nd indication for Oncomine Dx Target Test as a CDx for patients with EGFR exon 20 insertion mutations. The test is 1st FDA-approved NGS CDx that is used on FFPE tissue to identify patients for treatment with amivantamab who have progressed on or after Pt-based CT

 Ref: PR Newswire | Image: Thermo Fisher

Click here to­ read the full press release 

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