Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOncomine Dx Express Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLife Technologies Corporation
7335 Executive Way
Fredrick, MD 21704
PMA NumberP240040
Date Received11/12/2024
Decision Date07/02/2025
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03974022
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
Approval for the Oncomine Dx Express Test. The test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect substitutions, insertions, and deletions in 42 genes from DNA, copy number variants (CNVs) in 10 genes from DNA, and fusions or splice variants in 18 genes from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor samples, using the Genexus Dx™ Integrated Sequencer. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling (see approval order for Table 1).Additionally, the test is intended to provide tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 
-
-