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: Oncomine Dx Target Test
• Generic Name: Next generation sequencing oncology panel, somatic or germline variant detection system
• Applicant: Life Technologies Corporation; 5781 Van Allen Way; Carlbad, CA 92008
• PMA Number: P160045
• Supplement Number: S035
• Date Received: 03/08/2022
• Decision Date: 08/11/2022
• Product Code: PQP
• Docket Number: 22M-1951
• Notice Date: 08/19/2022
• Advisory Committee: Pathology
• Clinical Trials: NCT03505710
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to expand the indications for use to include a companion diagnostic indication for the detection of ERBB2 activating mutations (SNVs and exon 20 insertions) in non-small cell lung cancer patients who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2