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ProstateNow
Clinical Genetic Test
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offered by
GoPath Diagnostics
View lab's test page
LinkOut
GTR Test Accession: Help GTR000607920.1
NYS CLEP
CAP
CANCERREPRODUCTIVE HEALTHINHERITED DISEASE ... View more
Last updated in GTR: 2023-06-15
View version history
Last annual review date for the lab: 2023-06-14 LinkOut
At a Glance
Test purpose: Help
Monitoring; Mutation Confirmation; Predictive; ...
Conditions (4): Help
Malignant tumor of prostate; Familial prostate carcinoma; Malignant tumor of testis; ...
Genes (14): Help
ATM (11q22.3), ATR (3q23), BRCA1 (17q21.31), BRCA2 (13q13.1), CHEK2 (22q12.1), ...
Methods (1): Help
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Those who would benefit from this test are: 1. All …
Clinical validity: Help
Based on the results from our validation study, the assay …
Clinical utility: Help
Avoidance of invasive testing; Guidance for management; Predictive risk information for patient and/or family members
Ordering Information
Offered by: Help
GoPath Diagnostics
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Test Order Code: Help
ProstateNow
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

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.
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.
How to Order: Help
contact gopath labs to review ordering instructions and coordination for genetic counseling
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Genetic counseling
Test additional service: Help
Custom mutation-specific/Carrier testing
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Test strategy: Help
per physician or genetic counselor, if patient's family history warrants larger panel, testing can reflex to 88 gene panel
View citations (1)
  • Pilié PG, Johnson AM, Hanson KL, Dayno ME, Kapron AL, Stoffel EM, Cooney KA. Germline genetic variants in men with prostate cancer and one or more additional cancers. Cancer. 2017;123(20):3925-3932. doi:10.1002/cncr.30817. Epub 2017 Jun 28. PMID: 28657667.
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test
Conditions Help
Total conditions: 4
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 14
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina HiSeq™2000 system
Clinical Information
Test purpose: Help
Monitoring; Mutation Confirmation; Predictive; Prognostic; Risk Assessment; Screening; Therapeutic management
Clinical validity: Help
Based on the results from our validation study, the assay can detect SNV variants in a highly accurate performance with 98.1% of sensitivity, 100% of specificity as well as over 99% of positive and negative predictive values.
Clinical utility: Help
Avoidance of invasive testing
View citations (8)
  • Germline mutations in HOXB13 and prostate-cancer risk. Ewing CM, et al. N Engl J Med. 2012;366(2):141-9. doi:10.1056/NEJMoa1110000. PMID: 22236224.
  • Genetic variants associated with predisposition to prostate cancer and potential clinical implications. Goh CL, et al. J Intern Med. 2012;271(4):353-65. doi:10.1111/j.1365-2796.2012.02511.x. PMID: 22308973.
  • Stadler ZK, Schrader KA, Vijai J, Robson ME, Offit K. Cancer genomics and inherited risk. J Clin Oncol. 2014;32(7):687-98. doi:10.1200/JCO.2013.49.7271. Epub 2014 Jan 21. PMID: 24449244.
  • Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019;10(2):63-89. doi:10.14740/wjon1191. Epub 2019 Apr 20. PMID: 31068988.
  • Germline and Somatic Mutations in Prostate Cancer for the Clinician. Cheng HH, et al. J Natl Compr Canc Netw. 2019;17(5):515-521. doi:10.6004/jnccn.2019.7307. PMID: 31085765.
  • Brandão A, Paulo P, Teixeira MR. Hereditary Predisposition to Prostate Cancer: From Genetics to Clinical Implications. Int J Mol Sci. 2020;21(14). doi:10.3390/ijms21145036. Epub 2020 Jul 16. PMID: 32708810.
  • Sipeky C, Talala KM, Tammela TLJ, Taari K, Auvinen A, Schleutker J. Prostate cancer risk prediction using a polygenic risk score. Sci Rep. 2020;10(1):17075. doi:10.1038/s41598-020-74172-z. Epub 2020 Oct 13. PMID: 33051487.
  • Shi Z, Platz EA, Wei J, Na R, Fantus RJ, Wang CH, Eggener SE, Hulick PJ, Duggan D, Zheng SL, Cooney KA, Isaacs WB, Helfand BT, Xu J. Performance of Three Inherited Risk Measures for Predicting Prostate Cancer Incidence and Mortality: A Population-based Prospective Analysis. Eur Urol. 2021;79(3):419-426. doi:10.1016/j.eururo.2020.11.014. Epub 2020 Nov 28. PMID: 33257031.

Guidance for management
View citations (4)
  • Pritchard CC, Mateo J, Walsh MF, De Sarkar N, Abida W, Beltran H, Garofalo A, Gulati R, Carreira S, Eeles R, Elemento O, Rubin MA, Robinson D, Lonigro R, Hussain M, Chinnaiyan A, Vinson J, Filipenko J, Garraway L, Taplin ME, AlDubayan S, Han GC, Beightol M, Morrissey C, Nghiem B, Cheng HH, Montgomery B, Walsh T, Casadei S, Berger M, Zhang L, Zehir A, Vijai J, Scher HI, Sawyers C, Schultz N, Kantoff PW, Solit D, Robson M, Van Allen EM, Offit K, de Bono J, Nelson PS. Inherited DNA-Repair Gene Mutations in Men with Metastatic Prostate Cancer. N Engl J Med. 2016;375(5):443-53. doi:10.1056/NEJMoa1603144. Epub 2016 Jul 06. PMID: 27433846.
  • Pilié PG, Johnson AM, Hanson KL, Dayno ME, Kapron AL, Stoffel EM, Cooney KA. Germline genetic variants in men with prostate cancer and one or more additional cancers. Cancer. 2017;123(20):3925-3932. doi:10.1002/cncr.30817. Epub 2017 Jun 28. PMID: 28657667.
  • Christenson ES, Antonarakis ES. PARP inhibitors for homologous recombination-deficient prostate cancer. Expert Opin Emerg Drugs. 2018;23(2):123-133. doi:10.1080/14728214.2018.1459563. Epub 2018 Apr 04. PMID: 29595348.
  • Teyssonneau D, Margot H, Cabart M, Anonnay M, Sargos P, Vuong NS, Soubeyran I, Sevenet N, Roubaud G. Prostate cancer and PARP inhibitors: progress and challenges. J Hematol Oncol. 2021;14(1):51. doi:10.1186/s13045-021-01061-x. Epub 2021 Mar 29. PMID: 33781305.

Predictive risk information for patient and/or family members
View citations (3)
  • Stadler ZK, Schrader KA, Vijai J, Robson ME, Offit K. Cancer genomics and inherited risk. J Clin Oncol. 2014;32(7):687-98. doi:10.1200/JCO.2013.49.7271. Epub 2014 Jan 21. PMID: 24449244.
  • Brandão A, Paulo P, Teixeira MR. Hereditary Predisposition to Prostate Cancer: From Genetics to Clinical Implications. Int J Mol Sci. 2020;21(14). doi:10.3390/ijms21145036. Epub 2020 Jul 16. PMID: 32708810.
  • Darst BF, Sheng X, Eeles RA, Kote-Jarai Z, Conti DV, Haiman CA. Combined Effect of a Polygenic Risk Score and Rare Genetic Variants on Prostate Cancer Risk. Eur Urol. 2021;80(2):134-138. doi:10.1016/j.eururo.2021.04.013. Epub 2021 May 01. PMID: 33941403.

Target population: Help
Those who would benefit from this test are: 1. All men with a positive family history of cancers or prostate cancers. 2. Prostate cancer patients with high-risk, very-high-risk, regional or metastatic prostate cancer, regardless of family history. 3. Individuals with Ashkenazi Jewish ancestry 4. Prostate cancer patients for selection of … View more
View citations (11)
  • Germline mutations in HOXB13 and prostate-cancer risk. Ewing CM, et al. N Engl J Med. 2012;366(2):141-9. doi:10.1056/NEJMoa1110000. PMID: 22236224.
  • Genetic variants associated with predisposition to prostate cancer and potential clinical implications. Goh CL, et al. J Intern Med. 2012;271(4):353-65. doi:10.1111/j.1365-2796.2012.02511.x. PMID: 22308973.
  • Stadler ZK, Schrader KA, Vijai J, Robson ME, Offit K. Cancer genomics and inherited risk. J Clin Oncol. 2014;32(7):687-98. doi:10.1200/JCO.2013.49.7271. Epub 2014 Jan 21. PMID: 24449244.
  • Pilié PG, Johnson AM, Hanson KL, Dayno ME, Kapron AL, Stoffel EM, Cooney KA. Germline genetic variants in men with prostate cancer and one or more additional cancers. Cancer. 2017;123(20):3925-3932. doi:10.1002/cncr.30817. Epub 2017 Jun 28. PMID: 28657667.
  • Germline and Somatic Mutations in Prostate Cancer for the Clinician. Cheng HH, et al. J Natl Compr Canc Netw. 2019;17(5):515-521. doi:10.6004/jnccn.2019.7307. PMID: 31085765.
  • Brandão A, Paulo P, Teixeira MR. Hereditary Predisposition to Prostate Cancer: From Genetics to Clinical Implications. Int J Mol Sci. 2020;21(14). doi:10.3390/ijms21145036. Epub 2020 Jul 16. PMID: 32708810.
  • Sipeky C, Talala KM, Tammela TLJ, Taari K, Auvinen A, Schleutker J. Prostate cancer risk prediction using a polygenic risk score. Sci Rep. 2020;10(1):17075. doi:10.1038/s41598-020-74172-z. Epub 2020 Oct 13. PMID: 33051487.
  • Shi Z, Platz EA, Wei J, Na R, Fantus RJ, Wang CH, Eggener SE, Hulick PJ, Duggan D, Zheng SL, Cooney KA, Isaacs WB, Helfand BT, Xu J. Performance of Three Inherited Risk Measures for Predicting Prostate Cancer Incidence and Mortality: A Population-based Prospective Analysis. Eur Urol. 2021;79(3):419-426. doi:10.1016/j.eururo.2020.11.014. Epub 2020 Nov 28. PMID: 33257031.
  • Teyssonneau D, Margot H, Cabart M, Anonnay M, Sargos P, Vuong NS, Soubeyran I, Sevenet N, Roubaud G. Prostate cancer and PARP inhibitors: progress and challenges. J Hematol Oncol. 2021;14(1):51. doi:10.1186/s13045-021-01061-x. Epub 2021 Mar 29. PMID: 33781305.
  • Shi Z, Lu L, Resurreccion WK, Yang W, Wei J, Wang Q, Engelmann V, Zheng SL, Cooney KA, Isaacs WB, Helfand BT, Lu J, Xu J. Association of germline rare pathogenic mutations in guideline-recommended genes with prostate cancer progression: A meta-analysis. Prostate. 2022;82(1):107-119. doi:10.1002/pros.24252. Epub 2021 Oct 21. PMID: 34674288.
  • Shi Z, Zhan J, Wei J, Ladson-Gary S, Wang CH, Hulick PJ, Zheng SL, Cooney KA, Isaacs WB, Helfand BT, , Koelsch BL, Xu J. Reliability of Ancestry-specific Prostate Cancer Genetic Risk Score in Four Racial and Ethnic Populations. Eur Urol Open Sci. 2022;45:23-30. doi:10.1016/j.euros.2022.09.001. Epub 2022 Sep 17. PMID: 36353656.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Interpretation and classification of clinical significance of the detected variant are based on catalogued information from the NCBI ClinVar database (http://www.ncbi.nlm.nih.gov/clinvar/variation/), LOVD database (http://databases.lovd.nl/ shared/genes/) and other locus specific databases as well as information from published literatures.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Yes.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes. our GeneticsNow service covers it all - please use our website https://gopathdx.com or email geneticsnowsupport@gopathlabs.com
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Is research allowed on the sample after clinical testing is complete?
Technical Information
Test Platform:
Bioinformatics Analysis and Reporting (softgenetics (registered
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Result Summary of Validation: Twenty-nine out of 38 samples selected for the validation study contained at least 1 variant and a total of 52 known variants were included for the analysis. All known variants had been either previously confirmed by our Sanger sequencing method or reported in the samples by … View more
Assay limitations: Help
Two blood samples with known pathogenic variants (BRCA2, c.3308T>G and BLM, c.3558+1G>T) were selected for validation of the Limit-Of-Detection (LOD) performance of the assay. The 3 selected variants were serially diluted using normal DNA from the original allele frequencies of around 50% to 15%, 10%, 5% and 1% respectively. Sample … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
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 Help
NextGENe

Laboratory's policy on reporting novel variations Help
formal reports
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
NYS CLEP Approval: Help
Number: 9661
Status: Approved
Additional Information

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.