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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceCobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
ROCHE
4300 hacienda drive
po box 9002
pleasanton, CA 94588
PMA NumberP120019
Supplement NumberS019
Date Received02/23/2018
Decision Date08/22/2018
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R and T790M Exon 19 deletions, L858R and T790M* IRESSA® (gefitinib) Exon 19 deletions and L858R Exon 19 deletions and L858RPatients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Note: *The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2:Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861QTAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 20 insertions, S768I, and L861QIRESSA® (gefitinib) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.
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