Oncotype SEQ Liquid Select

Analytical Performance

High-quality standards from the industry leader

Oncotype SEQ Liquid Select is part of an integrated suite of patient-focused assays from Genomic Health—the trusted leader in genomic testing with more than 800,000 cancer patients worldwide.

Liquid Select leverages Genomic Health expertise, including Tumor Board review.

Analytical performance* demonstrates high per-sample sensitivity and specificity for variant detection1

SNV Indel Fusion CNV (gain)
Sensitivity Level to achieve a 95% detection rate 0.56% AF 0.19% AF 0.37% AF 2.7 copies
Lowest level detected 0.1% AF 0.1% AF 0.1% AF 2.4 copies
Specificity per sample >99% >99% >99% >99%

SNV = single nucleotide variants; INDEL = insertions and deletions; CNV = copy number variation; AF = allele fraction.
* Demonstrated in analytical validation with variant positive reference cell line samples (n=105) at 30–50 ng DNA input. Detection limits were selected above the Limit of Blank (LoB) corresponding to >99% per sample specificity among 73 cfDNA samples from 60 healthy volunteers.
†Represents mean AF/copies across variants tested.
‡Lowest level tested during analytical validation. Levels lower than this may be reported.

Genes and Alteration(s) Detected

Gene SNV Indel Fusion CNV (gain)
ALK
AR
BRAF
BRCA1
BRCA2
EGFR
ERBB2
ESR1
KIT
KRAS
MET
NRAS
PDGFRA
PIK3CA
PTEN
RET
ROS1

Assay Limitations

Genomic alterations may exist in a patient’s tumor that are not identified or reported by Liquid Select, including: genomic alterations other than those described in the above table, genomic alterations that are present at frequencies below the detection threshold, and genomic alterations that have insufficient evidence of clinical relevance [at the time of reporting]. Although allele fractions for SNVs and InDels are shown on the report, performance characteristics have only been established for a qualitative assay. In cases where both SNVs and InDels are detected, the allele fractions should not be compared relative to one another. Allele fractions represent the percentage of cfDNA in plasma with the genomic alteration and not the percentage of DNA in the tumor with the genomic alteration. The presence of high molecular weight DNA from lysed white blood cells may increase the likelihood of a technical failure or negative report, but it does not impact the specificity of the assay. Liquid Select may not be able to distinguish genomic alterations in genes from genomic alterations in pseudogenes.

REFERENCE

1. Svedman C, et al. ESMO 2016.

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