Tempus xF

xF Liquid Biopsy Test
Features
- 1
SNVs (single nucleotide variants) & insertions and deletions (indels): 105 Genes
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- 2
Immunotherapy Metrics: Microsatellite Instability High (MSI-H)
- 3
Copy Number Gains/Amplifications: 6 Genes
- 4
Copy Number Losses/Deletions: 2 Genes (BRCA1 & BRCA2)
- 5
Rearrangements/Fusion: 7 Genes
- 6
DNA Sequencing Depth: average 20,000x (raw reads)/5,000x (unique reads)
- 7
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Specimen types
- 1
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To monitor mechanisms of resistance
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To gain a comprehensive view of a patient¡¯s metastatic disease
Inter-, intra-tumorÀÇ ÀÌÁú¼ºÀº °íÇü Á¶Á÷ ¹× cfDNA ¾×ü »ý°Ë Å×½ºÆ®¿¡ Ȱ¿ë ½Ã ÁßøµÇÁö ¾Ê°í ÀáÀçÀûÀ¸·Î actionableÇÑ °á°ú µµÃâ. ÀÌ·¯ÇÑ Á¢±ÙÀº ¸ðµç Á¾¾ç ºÎÀ§¿¡ °ÉÃÄ Æ÷°ýÀûÀÎ Æò°¡¸¦ Á¦°øÇÒ ¼ö ÀÖÀ½(8)(9)(10)

REFERENCES
- Chabon, J., Simmons, A., Lovejoy, A. et al. (2016). doi:10.1038/ncomms11815
- Ihuegbu, N., Banks, K., Fairclough, S. et al. (2016). doi:10.1200/JCO.2016.34.15_suppl.e20643
- Fribbens, C., O¡¯Leary, B., Kilburn, L. et al. (2016). doi:10.1200/JCO.2016.67.3061
- Weigelt, B., Comino-Méndez, I., de Bruijn, I. et al. (2017). doi:10.1158/1078-0432.CCR-17-0544
- Azad, A., Volik, S., Wyatt, A. et al. (2015). doi:10.1158/1078-0432.CCR-14-2666
- Parikh, A.R., Leshchiner, I., Elagina, L. et al. (2019). doi:10.1038/s41591-019-0561-9
- Clifton, K., Rich, T., Parseghian, C. et al. (2019). doi:10.1200/PO.19.00141
- Aggarwal, C., Thompson, J., Black, T., et al. (2019). doi:10.1001/jamaoncol.2018.4305
- Schwaederle, M., Patel, S., Husain, H. et al. (2017). doi:10.1158/1078-0432.CCR-16-2497
- Maxwell, K., Soucier-Ernst, D., Tahirovic, E. et al. (2017). doi:10.1007/s10549-017-4257-x
Product

LIQUID BIOPSY
xF Plasma ctDNA (105 genes)Auto-conversion options from xT in event of tissue NGS failure/QNS
Testing for Solid Tumors
CANCER SITE | PANEL TEST | Normal specimen from clinic | Cancer specimen from clinic | Cancer specimen | |
---|---|---|---|---|---|
Solid tumor where a biopsy specimen is available | xT Solid Tumor | - | - | FFPE resection / biopsy | |
Solid tumor where a biopsy specimen is not readily available | xF Liquid Biopsy | - | Peripheral blood | - |
Testing for Hematologic Malignancies
CANCER SITE | PANEL TEST | Normal specimen from clinic | Cancer specimen from clinic | Cancer specimen | |
---|---|---|---|---|---|
Lymphoma (not in leukemic form) | xT Solid Tumor | Normal saliva | - | FFPE resection / biopsy | |
Leukemia, MDS, MPN | xT Heme | - | Peripheral blood or bone marrow aspirate | OR | FFPE bone marrow clot |
Multiple myeloma | xT Heme | Normal saliva | bone marrow aspirate | OR | FFPE bone marrow clot |
xF GENE PANEL
A non-invasive, liquid biopsy panel of 105 genes focused on oncogenic and resistance mutations in cell-free DNA (cfDNA). This panel is designed to provide clinical decision support for solid tumors.
- SNVs (single nucleotide variants) and insertions and deletions (indels) are detected in all 105 genes
- Copy Number Amplifications (CNAs), Copy Number Deletions (CNDs)©ö, and gene rearrangements (translocations) are detected in a subset of genes
- DNA Sequencing Depth: average 20,000x (raw reads)/5,000x (unique reads)
- Specimen Requirements: Two Streck tubes of peripheral blood (8.5mL each)
The report includes genomic alterations in select genes, microsatellite instability status©÷, median variant allele fraction (mVAF), therapy options and clinical trials matched to the patient¡¯s genomic profile, as well as clinical history.
xF GENE PANEL
AKT1 | BRAF | CDK6 | FGFR1 | HRAS | MAP2K1 | MYCN | PDGFRA | RET | TERT |
AKT2 | BRCA1 | CDKN2A | FGFR2 | IDH1 | MAP2K2 | NF1 | PDGFRB | RHEB | TP53 |
ALK | BRCA2 | CTNNB1 | FGFR3 | IDH2 | MAPK1 | NF2 | PIK3CA | RHOA | TSC1 |
APC | BTK | DDR2 | FGFR4 | JAK1 | MET | NFE2L2 | PIK3R1 | RIT1 | TSC2 |
AR | CCND1 | DPYD | FLT3 | JAK2 | MLH1 | NOTCH1 | PMS2 | RNF43 | UGT1A1 |
ARAF | CCND2 | EGFR | FOXL2 | JAK3 | MPL | NPM1 | PTCH1 | ROS1 | VHL |
ARID1A | CCND3 | ERBB2 (HER2) | GATA3 | KDR | MSH2 | NRAS | PTEN | SDHA | |
ATM | CCNE1 | ERRFI1 | GNA11 | KEAP1 | MSH3 | NTRK1 | PTPN11 | SMAD4 | |
ATR | CD274 (PD-L1) | ESR1 | GNAQ | KIT | MSH6 | PALB2 | RAD51C | SMO | |
B2M | CDH1 | EZH2 | GNAS | KMT2A | MTOR | PBRM1 | RAF1 | SPOP | |
BAP1 | CDK4 | FBXW7 | HNF1A | KRAS | MYC | PDCD1LG2 | RB1 | STK11 |
GENE REARRANGEMENTS
ALK | BRAF | FGFR2 | FGFR3 | NTRK1 | RET | ROS1 |
COPY NUMBER GAINS
CCNE1 | CD274 (PD-L1) | EGFR | ERBB2 (HER2) | MET | MYC |
COPY NUMBER LOSSES
BRCA1 | BRCA2 |
PERFORMANCE SPECIFICATIONS
Variant Allele Fraction (VAF) | Sensitivity3 | |
---|---|---|
Single Nucleotide Variants (SNV) | >0.5% | >99.9% |
0.50% | >99.9% | |
0.25% | 97% | |
0.10%4 | 70.4% | |
Insertions and Deletions | >0.5% | 98.8% |
0.50% | 96.0% | |
0.25% | 81.0% | |
Copy Number Amplifications (CNAs) | >0.5% | >99.9% |
0.5% | >99.9% | |
Rearrangements/Fusions | >0.5% | 97.4% |
0.50% | 70.8% |
ANALYTICAL SPECIFICITY
Variant Type | Specificity3 |
---|---|
SNV | >99.9% |
INDEL | >99.9% |
CNA | 96.2% |
Fusion | >99.9% |
1. BRCA1 and BRCA2 copy number loss are reported when detected
2. MSI status will be reported when the specimen is determined to be MSI-High
3. Established using reference materials
4. For selected hot spot regions