Metadata record for the manuscript: Analytical validation of a targeted liquid biopsy assay with comprehensive molecular and clinical profiling of circulating tumor DNA from 1,000 patients

Summary

This
metadata record provides details of the data supporting the claims of the
related manuscript: “Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA”.

The
related study presents extensive validation studies of the Tempus xF liquid
biopsy assay (a 105-gene, hybrid-capture, next-generation sequencing (NGS)
assay that detects single-nucleotide variants, insertions/deletions, copy
number variants, and chromosomal rearrangements) using reference standards,
cell lines, and patient samples that establish high sensitivity, specificity,
and accuracy in variant detection.

Type of data:
liquid biopsy

Subject of
data: Homo sapiens

Sample size:
1000

Recruitment:
randomly selected cancer patients who had clinical plasma specimens sequenced
with the xF panel at CAP/CLIA-certified Tempus Labs, Inc.

Data
access

The de-identified clinical data that
support findings from the retrospective profiling study have been deposited in
the Vivli repository (https://vivli.org/) in the file ‘xf_1000_De-identified_Phenotypic_Data_and_ctFE.tsv’
under the following accession: T20.01 (https://search.vivli.org/?search=T20.01). Access is restricted, and interested
parties must make an authorised request to the Vivli repository.

The
following supplementary tables are openly available in accessible format as
part of this figshare data record:

- Supplementary
Table 4.xlsx. This table underlies Figure 1 of the related article: Inter-assay
comparison between Tempus xF, ddPCR, and Tempus xT results.

- Supplementary
Table 1. Analysis Variants detected by the Tempus xF assay

- Supplementary
Table 2. Overview of samples and experiments

- Supplementary
Table 3. Probabilistic noise filtering methodology improves variant

Raw data
from the validation experiments were generated and analysed as part of a
CAP/CLIA validation. As such, they are not publicly available but have been
thoroughly reviewed by those governing authorities.

Corresponding author(s) for this study

Nike
Beaubier, Tempus Labs, Chicago, IL, USA. [e-mail].

Study
approval

The
study protocol was submitted to the Advarra Institutional Review Board (IRB),
which determined the research was exempt from IRB oversight and approved a
waiver of HIPAA authorization for this study.