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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantExact Sciences Corporation
5505 Endeavor Lane
Madison, WI 53719
PMA NumberP210040
Date Received12/28/2021
Decision Date12/12/2022
Product Code PQP 
Docket Number 22M-3219
Notice Date 12/16/2022
Advisory Committee
Clinical TrialsNCT03785249
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Agilent Resolution ctDx FIRST assay. The device is a qualitative next generation sequencing-based, in vitro diagnostic test that uses targeted hybrid-capture sequencing technology to detect and report single nucleotide variants (SNVs) and deletions in two genes. The Agilent Resolution ctDx FIRST assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who may benefit from treatment with the targeted therapy listed in Table 1, in accordance with the approved therapeutic labeling.Table 1. Companion Diagnostic IndicationIndication: Non-small cell lung cancer (NSCLC); Biomarker: KRAS G12C; Therapy: KRAZATI (adagrasib) A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. Patients with NSCLC who are negative for the biomarker listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarker using an FDA-approved tumor tissue test, if feasible.Additionally, the test is intended to provide tumor mutation profiling for SNVs and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with NSCLC. The test is for use with patients previously diagnosed with NSCLC and in conjunction with other laboratory and clinical findings.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.The Agilent Resolution ctDx FIRST assay is a single-site assay performed at Resolution Bioscience, Inc.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001