[FDA] List of cleared or approved companion diagnostic devices (in vitro and imaging tools)

FDA updated of the list of cleared or approved companion diagnostic devices (in vitro and imaging tools).

 

- Device: CRCDx RAS mutation detection assay kit

- Generic name: somatic gene mutation detection system

- Applicant: EntroGen, Inc

- PMA number: P220005 

- Approval order statement

  Approval for the CRCdx® RAS Mutation Detection Kit. The device is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result in accordance with the approved therapeutic product labeling.

 

 

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) | FDA

List of Cleared or Approved Companion Diagnostic Devices

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