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Percepta Genomic Sequencing Classifier
Clinical Genetic Test
Help
offered by
Veracyte, Inc.
GTR Test Accession: Help GTR000596284.2
NYS CLEP
RESPIRATORY DISEASE
Last updated in GTR: 2023-01-03
View version history
Last annual review date for the lab: 2024-01-02 LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (1): Help
Disorder of lung
Chromosomal regions/ Mitochondria (1): Help
Whole exome
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Current or former smokers, without a lung cancer diagnosis, who …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Veracyte, Inc.
View lab's website
Test short name: Help
Percpeta GSC
Manufacturer's name: Help
Veracyte, Inc
Specimen Source: Help
Who can order: Help
  • Nurse Practitioner
  • Health Care Provider
  • Physician Assistant
  • Licensed Physician
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Robert Monroe, PhD, MD, ABPath, SM(ASCP), Lab Director
support@veracyte.com
650-243-6300
Contact Policy: Help
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: Help
Testing can only be ordered by medical provider with valid NPI. Sample collection kits are provided by Veracyte to the ordering physician. Both the sample collection vial and requisition form are submitted to Veracyte via pre-labeled shippers, sent via FEDEX Monday -Saturday.
Order URL
Test service: Help
Custom Sequence Analysis
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Clinical Information
Test purpose: Help
Diagnosis
Target population: Help
Current or former smokers, without a lung cancer diagnosis, who are identified with lung nodules <30mm and have a non-diagnostic/inconclusive bronchoscopy
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Johnson MK, Wu S, Pankratz DG, Fedorowicz G, Anderson J, Ding J, Wong M, Cao M, Babiarz J, Lofaro L, Walsh PS, Kennedy GC, Huang J. Analytical validation of the Percepta genomic sequencing classifier; an RNA next generation sequencing assay for the assessment of Lung Cancer risk of suspicious pulmonary … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 71359
Status: Approved
Additional Information
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.