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

<b>Summary</b><br>

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: <i>Homo sapiens</i>

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.

<b>Data
access</b>

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 <i>figshare </i>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.

<b>Corresponding author(s) for this study</b>

Nike
Beaubier, Tempus Labs, Chicago, IL, USA. [e-mail].<br>
<br>
<b></b>

<b>Study
approval </b>

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.