GTR Test Accession:
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GTR000569040.1
NYS CLEP
CAP
Last updated in GTR:
2024-11-07
View version history
GTR000569040.5,
last updated:
2022-09-01
GTR000569040.4,
last updated:
2021-09-16
GTR000569040.3,
last updated:
2021-09-15
GTR000569040.2,
last updated:
2020-09-17
GTR000569040.1,
registered in GTR:
2019-09-27
GTR000569040.1,
registered in GTR:
2024-11-07
Last annual review date for the lab: 2024-10-28
LinkOut
At a Glance
Test purpose:
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Drug Response;
Predictive;
Prognostic; ...
Conditions (1):
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Solid tumor
Genes (105):
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Methods (2):
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Molecular Genetics - Microsatellite instability testing (MSI): Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients with advanced and metastatic solid cancers; Monitoring of a …
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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xF
Specimen Source:
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- Cell-free DNA
- Peripheral (whole) blood
- Plasma
Who can order: Help
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
Contact Policy:
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Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order:
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To order the Tempus test:
1. Retrieve the Tempus xF collection kit. All required forms are contained in the box.
2. Complete the Requisition Form. A physician's signature is required.
4. Complete the Financial Assistance Form with the patient.
5. Fax the Requisition Form, Financial Assistance Form, and accompanying …
1. Retrieve the Tempus xF collection kit. All required forms are contained in the box.
2. Complete the Requisition Form. A physician's signature is required.
4. Complete the Financial Assistance Form with the patient.
5. Fax the Requisition Form, Financial Assistance Form, and accompanying …
Order URL
Test service:
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DNA sequencing for 105 genes
Comment: SNVs (105 genes), indels (105 genes), amplifications (6 genes), copy number loss (2 genes), gene rearrangements (7 genes)
Comment: SNVs (105 genes), indels (105 genes), amplifications (6 genes), copy number loss (2 genes), gene rearrangements (7 genes)
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Yes
Test strategy:
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The Tempus xF assay is a non-invasive, liquid biopsy panel designed to provide clinical decision support for solid tumors. It detects genomic alterations circulating in patients' peripheral blood, including single nucleotide variants (SNVs)/insertions and deletions (indels) in 105 genes, copy number gains (CNGs) in 6 genes, copy number losses (CNLs) …
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Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Lab contact for this test
Conditions
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Total conditions: 1
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
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Total genes: 105
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 2
Method Category
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Test method
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Instrument
Microsatellite instability testing (MSI)
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000 System
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000 System
Clinical Information
Test purpose:
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Drug Response;
Predictive;
Prognostic;
Therapeutic management
Target population:
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Patients with advanced and metastatic solid cancers; Monitoring of a patient’s response to treatment/ development of resistance;
Patients with tumors that are not accessible (e.g. tumor location, patient health); Patients with tissue specimens insufficient for sequencing (pathology rejection, insufficient quantity/ quality of DNA, etc.)
View citations (12)
- Ghatalia P, Smith CH, Winer A, Gou J, Kiedrowski LA, Slifker M, Saltzberg PD, Bubes N, Anari FM, Kasireddy V, Varshavsky A, Liu Y, Ross EA, El-Deiry WS. Clinical Utilization Pattern of Liquid Biopsies (LB) to Detect Actionable Driver Mutations, Guide Treatment Decisions and Monitor Disease Burden During Treatment of 33 Metastatic Colorectal Cancer (mCRC) Patients (pts) at a Fox Chase Cancer Center GI Oncology Subspecialty Clinic. Front Oncol. 2018;8:652. doi:10.3389/fonc.2018.00652. Epub 2019 Jan 17. PMID: 30705875.
- PMID: 25185240
- PMID: 26546295
- PMID: 27784960
- PMID: 28146051
- PMID: 28419195
- PMID: 28500398
- PMID: 28945887
- PMID: 29512873
- PMID: 30240661
- PMID: 30462523
- PMID: 30916594
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Tempus uses an internally-built proprietary algorithm based on ACMG/AMP/ASCO guidelines for variant classification. Variants are reported in a tiered structure based on classification and therapeutic actionability. Variants with insufficient evidence to be classified as either pathogenic, likely pathogenic, likely benign or benign are classified as Variants of Uncertain Significance (VUS). … View more
Tempus uses an internally-built proprietary algorithm based on ACMG/AMP/ASCO guidelines for variant classification. Variants are reported in a tiered structure based on classification and therapeutic actionability. Variants with insufficient evidence to be classified as either pathogenic, likely pathogenic, likely benign or benign are classified as Variants of Uncertain Significance (VUS). … View more
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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No.
No.
Sample reports:
Recommended fields not provided:
Clinical validity,
Clinical utility,
Is research allowed on the sample after clinical testing is complete?,
Sample positive report
Technical Information
Test Platform:
Other
Availability:
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Tests performed
Entire test performed in-house
Test performance comments
Tempus xF test is performed in its entirety at Tempus Labs, Chicago, IL.
Entire test performed in-house
Test performance comments
Tempus xF test is performed in its entirety at Tempus Labs, Chicago, IL.
Analytical Validity:
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The sensitivity of the Tempus xF panel is >99% for single nucleotide variants (SNVs) and copy number gains (CNGs) at ≥0.5% variant allele fraction (VAF), and >98% for insertions/deletions (indels) and >97% for rearrangements >0.5% VAF. BRCA1 and BRCA2 copy number loss is reported when detected. The specificity is >99.9% …
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View citations (1)
- https://pubmed.ncbi.nlm.nih.gov/34215841/
Assay limitations:
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Not Intended For:
▪ Hematologic malignancies
▪ Early-stage (stage I/II) cancers
▪ Primary CNS malignancies
View citations (1)
- https://pubmed.ncbi.nlm.nih.gov/34215841/
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
VUS:
Software used to interpret novel variations
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Not provided
Laboratory's policy on reporting novel variations Help
Tempus reports novel variants if detected somatically and classified as pathogenic, likely pathogenic, or VUS.
Not provided
Laboratory's policy on reporting novel variations Help
Tempus reports novel variants if detected somatically and classified as pathogenic, likely pathogenic, or VUS.
Recommended fields not provided:
Test Confirmation,
Description of internal test validation method,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
NYS CLEP Approval:
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Number:
63002
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.