GTR Test Accession:
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GTR000503131.10
NYS CLEP
Last updated in GTR:
2020-07-21
View version history
GTR000503131.10,
last updated:
2020-07-21
GTR000503131.9,
last updated:
2020-05-26
GTR000503131.8,
last updated:
2019-10-16
GTR000503131.7,
last updated:
2018-01-25
GTR000503131.6,
last updated:
2017-01-24
GTR000503131.5,
last updated:
2016-08-19
GTR000503131.4,
last updated:
2016-01-28
GTR000503131.3,
last updated:
2016-01-21
GTR000503131.2,
last updated:
2014-05-20
GTR000503131.1,
registered in GTR:
2013-06-04
Last annual review date for the lab: 2024-01-25
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At a Glance
Methods (1):
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Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Pregnant women
Clinical validity:
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Panorama® is a screening test for common aneuploidies (trisomy 13, …
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Dentist
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
- Registered Nurse
CPT codes:
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Contact Policy:
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Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order:
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Contact Natera, Inc at 650-249-9090 for kit. Alternatively, 2 x 10cc Streck tubes at room temperature.
Order URL
Order URL
Test service:
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Genetic counseling
Comment: pre and post test consults available
Comment: pre and post test consults available
Test development:
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Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required:
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No
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,
Test strategy
Conditions
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Total conditions: 12
Condition/Phenotype | Identifier |
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Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 10
Chromosomal region/Mitochondrion | Associated condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
SNP Detection
* Instrument: Not provided
Clinical Information
Test purpose:
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Screening
Clinical validity:
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Panorama® is a screening test for common aneuploidies (trisomy 13, trisomy 18, trisomy 21, sex chromosome aneuploidy, and triploidy). Panorama’s Extended panel also includes screening for these microdeletion syndromes: 22q11.2 deletion syndrome, Prader Willi syndrome, Angelman syndrome, Cri du Chat syndrome, and 1p36 deletion syndrome. By utilizing SNPs and unique …
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View citations (2)
- Dar P, Curnow KJ, Gross SJ, Hall MP, Stosic M, Demko Z, Zimmermann B, Hill M, Sigurjonsson S, Ryan A, Banjevic M, Kolacki PL, Koch SW, Strom CM, Rabinowitz M, Benn P. Clinical experience and follow-up with large scale single-nucleotide polymorphism-based noninvasive prenatal aneuploidy testing. Am J Obstet Gynecol. 2014;211(5):527.e1-527.e17. doi:10.1016/j.ajog.2014.08.006. Epub 2014 Aug 08. PMID: 25111587.
- Wapner RJ, Babiarz JE, Levy B, Stosic M, Zimmermann B, Sigurjonsson S, Wayham N, Ryan A, Banjevic M, Lacroute P, Hu J, Hall MP, Demko Z, Siddiqui A, Rabinowitz M, Gross SJ, Hill M, Benn P. Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes. Am J Obstet Gynecol. 2015;212(3):332.e1-9. doi:10.1016/j.ajog.2014.11.041. Epub 2014 Dec 02. PMID: 25479548.
Target population:
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Pregnant women
View citations (2)
- Committee Opinion No. 640: Cell-Free DNA Screening For Fetal Aneuploidy. Obstet Gynecol. 2015;126(3):e31-e37. doi:10.1097/AOG.0000000000001051. PMID: 26287791.
- Gregg AR, Skotko BG, Benkendorf JL, Monaghan KG, Bajaj K, Best RG, Klugman S, Watson MS. Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18(10):1056-65. doi:10.1038/gim.2016.97. Epub 2016 Jul 28. PMID: 27467454.
Recommended fields not provided:
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?,
Sample negative report,
Sample positive report
Technical Information
Test Comments:
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For singleton pregnancies: Panorama® is a screening test for common aneuploidies (trisomy 13, trisomy 18, trisomy 21, sex chromosome aneuploidy, triploidy and 22q11.2). By utilizing SNPs and unique bioinformatics to differentiate between the maternal and fetal genotype, Panorama has high sensitivity and specificity in the NIPT industry for these conditions. …
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Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Using the Next-generation Aneuploidy Test Using SNPs (NATUS) algorithm, the PanoramaTM prenatal screening test is >99% sensitive and >99% specific for Trisomy 21 (Down Syndrome), Trisomy 13 (Patau Syndrome), triploidy, and fetal sex. Sensitivity for Trisomy 18 (Edwards Syndrome) is 96.4% and for Monosomy X is 92.9% with specificity for …
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View citations (2)
- Faas BH, Odibo AO, Cirigliano V, Schielen P, Pergament D, Devers P, Oepkes D, Benn P. Summary of the ISPD Preconference Day, June 3, 2012, Miami Beach. Prenat Diagn. 2013;33(1):1-5. doi:10.1002/pd.4007. Epub 2012 Nov 07. PMID: 23132177.
- Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low-risk cohort. Pergament E, et al. Obstet Gynecol. 2014;124(2 Pt 1):210-218. doi:10.1097/AOG.0000000000000363. PMID: 25004354.
Assay limitations:
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Samples not accepted for multiple gestation when an egg donor and/or a surrogate is used. Samples are also not accepted for patients who have had bone marrow transplant.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Description of internal test validation method,
PT Provider,
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:
8417
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
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.