Resolution ctDx FIRST
Designed for Liquid.
Developed for Action.
Resolution ctDx FIRST is a liquid biopsy NGS assay optimized for cancer genomic profiling.

ctDx FIRST is an FDA approved companion diagnostic to KRAZATITM (adagrasib) for the detection of KRAS G12C in non-small cell lung cancer (NSCLC) and provides tumor mutation profiling for single nucleotide variants (SNVs) and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines.

Additionally, the professional services portion of the test report includes comprehensive genomic profiling on 109 genes across 4 types of alterations.

Using our proprietary technology, we can detect fusions without a priori knowledge§ of the gene partner.1,*

Insight into clinically significant classes of alterations,2 including fusions3-5 and CNAs,6 which have been historically challenging to detect with cfDNA-based tests

109
genes associated with solid tumor malignancies
103
genes with SNV/Indel detection††
54
genes with copy number amplification detection
13
genes with fusion detection

Assay Panel

Mutations (Hover over each mutational type to highlight genes covered)
ABL1  
AKT1  
AKT2  
ALK  
AR  
ARAF  
ARID1A  
ATM  
ATR  
ATRX  
B2M  
BAP1  
BARD1  
BRAF  
BRCA1  
BRCA2  
BRD4  
BRIP1  
CCND1  
CCND2  
CCNE1  
CD274  
CDK12  
CDK4  
CDK6  
CDKN2A  
CHEK1  
CHEK2  
CTNNB1  
DDR2  
DNMT3A  
EGFR  
ERBB2  
ERBB3  
ERBB4  
ERCC2  
ESR1  
EZH2  
FANCA  
FANCC  
FANCL  
FBXW7  
FGF3  
FGFR1  
FGFR2  
FGFR3  
FGFR4  
FLT3  
GNA11  
GNAQ  
GNAS  
HGF  
HRAS  
IDH1  
IDH2  
JAK1  
JAK2  
KEAP1  
KIT  
KRAS  
MAP2K1  
MAP2K2  
MDM2  
MET  
MLH1  
MSH2  
MSH6  
MTOR  
MYC  
MYD88  
NF1  
NF2  
NPM1  
NRAS  
NRG1  
NTRK1  
NTRK2  
NTRK3  
PALB2  
PDGFRA  
PDGFRB  
PIK3CA  
PMS2  
POLE  
PTCH1  
PTEN  
PTPN11  
RAC1  
RAD50  
RAD51B  
RAD51C  
RAD51D  
RAD54L  
RAF1  
RB1  
RET  
RICTOR  
ROS1  
SMARCA4  
SMARCB1  
SMO  
STAG2  
STK11  
TERT  
TP53  
TSC1  
TSC2  
VEGFA  
VHL  
Footnotes:
CLIA-certified, not FDA approved
§NRTK3: Only fusions with ETV6 fusion partner are detected
*In conjunction with validated probe placement and tiling density, our proprietary primer extension technology enables capture of fusion partner without knowing the adjacent genomic sequence
††SNV/indels: 64% of genes have full coding sequence (CDS) coverage

Intended Use:
The Resolution ctDx FIRST assay 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 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 non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib), in accordance with the approved therapeutic labeling. 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 KRAS G12C biomarker should be reflexed to tissue biopsy testing 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 KRAS G12C are not prescriptive or conclusive for labeled use of any specific therapeutic product. The Resolution ctDx FIRST assay is a single-site assay performed at Resolution Bioscience, Inc.

References:
1. Data on file. 2022.
2. Chakravrty, D.; Gao, J.; Phillips, S.; Kundra, R.; Zhang, H.; Wang, J.; Rudolph, J. E.; Yaeger, R.; Soumerai, T.; Nissan, M. H.; Chang, M. T.; Chandarlapaty, S.; Traina, T. A.; Paik, P. K.; Ho, A. L.; Hantash, F. M.; Grupe, A.; Baxi, S. S.; Callahan, M. K.; Snyder, A.; Chi, P.; Danila, D. C.; Gounder, M.; Harding, J. J.; Hellmann, M. D.; Iyer, G.; Janjigian, Y. Y.; Kaley, T.; Levine, D. A.; Lowery, M.; Omuro, A.; Postow, M. A.; Rathkopf, D.; Shoushtari, A. N.; Shukla, N.; Voss, M. H.; Paraiso, E.; Zehir, A.; Berger, M. F.; Taylor, B. S.; Saltz, L. B.; Riely, G. J.; Ladanyi, M.; Hyman, D. M.; Baselga, J.; Sabbatini, P.; Solit, D. B.; Schultz, N. OncoKB: A Precision Oncology Knowledge Base. https://www.oncokb.org/actionableGenes#levels=1§ions=Tx (accessed 2022-09-15).
3. Paweletz, C. P.; Sacher, A. G.; Raymond, C. K.; Alden, R. S.; O'Connell, A.; Mach, S. L.; Kuang, Y.; Gandhi, L.; Kirschmeier, P.; English, J. M.; Lim, L. P.; Jänne, P. A.; Oxnard, G. R. Bias-corrected Targeted Next-Generation Sequencing for Rapid, Multiplexed Detection of Actionable Alterations in Cell-free DNA from Advanced Lung Cancer Patients. Clin. Cancer Res. 2016, 22 (4), 915-922. DOI: 10.1158/1078-0432.CCR-15-1627-T.
4. Mondaca, S.; Lebow, E. S.; Namakydoust, A.; Razavi, P.; Reis-Filho, J. S.; Shen, R.; Offin, M.; Tu H.; Murciano-Goroff, Y.; Xu, C.; Makhnin, A.; Martinez, A.; Pavlakis, N.; Clarke, S.; Itchins, M.; Lee, A.; Rimner, A.; Gomez, D.; Rocco, G.; Chaft, J. E.; Riely, G. J.; Rudin, C. M.; Jones, D. R.; Li, M.; Shaffer, T.; Hosseini, S. A.; Bertucci, C.; Lim, L. P.; Drilon, A.; Berger, M. F.; Benayed, R.; Arcila, M. E.; Isbell, J. M.; Li, B. T. Clinical Utility of Next-Generation Sequencing-based ctDNA Testing for Common and Novel ALK Fusions. Lung Cancer. 2021, 159, 66-73. DOI: 10.1016/j.lungcan.2021.06.018.
5. Supplee, J. G.; Milan, M. S. D.; Lim, L. P.; Potts, K. T.; Sholl, L. M.; Oxnard, G. R.; Paweletz, C. P. Sensitivity of next-generation sequencing assays detecting oncogenic fusions in plasma cell-free DNA. Lung Cancer. 2019, 134, 96-99.
6. Viailly, P.; Sater, V.; Viennot, M.; Bohers, E.; Vergne, N.; Berard, C.; Dauchel, H.; Lecroq, T.; Celebi, A.; Ruminy, P.; Marchand, V.; Lanic, M.; Dubois, S.; Penther, D.; Tilly, H.; Mareschal, S.; Jardin, F. Improving High-Resolution Copy Number Variation Analysis from Next Generation Sequencing Using Unique Molecular Identifiers. BMC Bioinformatics. 2021, 22 (120). DOI: 10.1186/s12859-021-04060-4.

PR7001-0232