Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: THERASCEEN EGFR RGQ PCR KIT
• Generic Name: Somatic gene mutation detection system
• Applicant: QIAGEN GmbH; QIAGEN Strasse 1; Hilden 40724
• PMA Number: P120022
• Supplement Number: S001
• Date Received: 09/18/2014
• Decision Date: 07/10/2015
• Product Code: OWD
• Advisory Committee: Pathology
• Clinical Trials: NCT01203917
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR EXTENDING THE LABEL CLAIM OF THE THERASCREEN® EGFR RGQ PCR KIT TO INCLUDE AN INDICATION FOR IRESSA (GEFITINIB). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERASCREEN® EGFR RGQ PCR KIT AND IS INDICATED FOR:THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRIF (AFATINIB) OR IRESSA (GEFITINIB), EGFR TYROSINE KINASE INHIBITORS (TKIS), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) AND IRESSA (GEFITINIB) HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WHOSE TUMORS HAVE L861Q, G719X, S768I, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN EGFR RGQ PCR KIT.SPECIMENS ARE PROCESSED USING THE QIAAMP DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION AND DETECTION.