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Items: 1 to 20 of 100

1.

Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing.

Kim AS, Bartley AN, Bridge JA, Kamel-Reid S, Lazar AJ, Lindeman NI, Long TA, Merker JD, Rai AJ, Rimm DL, Rothberg PG, Vasalos P, Moncur JT.

JAMA Oncol. 2018 Jun 1;4(6):838-841. doi: 10.1001/jamaoncol.2017.4021.

2.

Performance Comparison of Different Analytic Methods in Proficiency Testing for Mutations in the BRAF, EGFR, and KRAS Genes: A Study of the College of American Pathologists Molecular Oncology Committee.

Moncur JT, Bartley AN, Bridge JA, Kamel-Reid S, Lazar AJ, Lindeman NI, Long TA, Merker JD, Rai AJ, Rimm DL, Rothberg PG, Vasalos P, Kim AS.

Arch Pathol Lab Med. 2019 Apr 10. doi: 10.5858/arpa.2018-0396-CP. [Epub ahead of print]

PMID:
30969158
3.

Next-Generation Sequencing (NGS) Methods Show Superior or Equivalent Performance to Non-NGS Methods on BRAF, EGFR, and KRAS Proficiency Testing Samples.

Surrey LF, Oakley FD, Merker JD, Long TA, Vasalos P, Moncur JT, Kim AS.

Arch Pathol Lab Med. 2019 Mar 13. doi: 10.5858/arpa.2018-0394-CP. [Epub ahead of print]

PMID:
30865489
4.

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

Tazawa Y.

Breast Cancer. 2016 Jan;23(1):19-23. doi: 10.1007/s12282-015-0586-y. Epub 2015 Jan 22.

PMID:
25605056
5.

The Clinical and Economic Impact of Inaccurate EGFR Mutation Tests in the Treatment of Metastatic Non-Small Cell Lung Cancer.

Cheng MM, Palma JF, Scudder S, Poulios N, Liesenfeld O.

J Pers Med. 2017 Jun 28;7(3). pii: E5. doi: 10.3390/jpm7030005.

6.

College of american pathologists proposal for the oversight of laboratory-developed tests.

Vance GH.

Arch Pathol Lab Med. 2011 Nov;135(11):1432-5. doi: 10.5858/arpa.2011-0304-SA. Review.

PMID:
22032569
7.

Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

Caliendo AM, Hanson KE.

J Clin Microbiol. 2016 Apr;54(4):829-33. doi: 10.1128/JCM.00063-16. Epub 2016 Jan 20.

8.

Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

Caliendo AM, Couturier MR, Ginocchio CC, Hanson KE, Miller MB, Walker KE, Frank GM; Infectious Diseases Society of America; the American Society for Microbiology; and the Pan-American Society for Clinical Virology.

Clin Infect Dis. 2016 Jul 15;63(2):151-4. doi: 10.1093/cid/ciw260. Epub 2016 Apr 26.

PMID:
27118790
9.

Laboratory-Developed Tests: A Legislative and Regulatory Review.

Genzen JR, Mohlman JS, Lynch JL, Squires MW, Weiss RL.

Clin Chem. 2017 Oct;63(10):1575-1584. doi: 10.1373/clinchem.2017.275164. Epub 2017 Jul 7. Review.

10.

Update on the College of American Pathologists Experience With High-Risk Human Papillomavirus Proficiency Testing for Cytology.

Ghofrani M, Zhao C, Davey DD, Fan F, Husain M, Laser A, Ocal IT, Shen RZ, Goodrich K, Souers RJ, Crothers BA.

Arch Pathol Lab Med. 2016 Dec;140(12):1371-1374. Epub 2016 Aug 24.

PMID:
27557412
11.

Proficiency testing experience with College of American Pathologists' programs at a university hospital in China from 2007 to 2011.

Liu X, Dai Q, Jiang Y.

Arch Pathol Lab Med. 2014 Jan;138(1):114-20. doi: 10.5858/arpa.2012-0526-OA.

PMID:
24377819
12.

Good clinical laboratory practices improved proficiency testing performance at clinical trials centers in Ghana and Burkina Faso.

Ibrahim F, Dosoo D, Kronmann KC, Ouedraogo I, Anyorigiya T, Abdul H, Sodiomon S, Owusu-Agyei S, Koram K.

PLoS One. 2012;7(6):e39098. doi: 10.1371/journal.pone.0039098. Epub 2012 Jun 29.

13.

CAP/ACMG proficiency testing for biochemical genetics laboratories: a summary of performance.

Oglesbee D, Cowan TM, Pasquali M, Wood TC, Weck KE, Long T, Palomaki GE.

Genet Med. 2018 Jan;20(1):83-90. doi: 10.1038/gim.2017.61. Epub 2017 Jun 29.

14.
15.

Proficiency Testing of Standardized Samples Shows Very High Interlaboratory Agreement for Clinical Next-Generation Sequencing-Based Oncology Assays.

Merker JD, Devereaux K, Iafrate AJ, Kamel-Reid S, Kim AS, Moncur JT, Montgomery SB, Nagarajan R, Portier BP, Routbort MJ, Smail C, Surrey LF, Vasalos P, Lazar AJ, Lindeman NI.

Arch Pathol Lab Med. 2019 Apr;143(4):463-471. doi: 10.5858/arpa.2018-0336-CP. Epub 2018 Oct 30.

PMID:
30376374
16.

Evaluation of blood lead proficiency testing: comparison of open and blind paradigms.

Parsons PJ, Reilly AA, Esernio-Jenssen D, Werk LN, Mofenson HC, Stanton NV, Matte TD.

Clin Chem. 2001 Feb;47(2):322-30.

17.

Highly accurate molecular genetic testing for HFE hereditary hemochromatosis: results from 10 years of blinded proficiency surveys by the College of American Pathologists.

Press RD, Eickelberg G, McDonald TJ, Halley J, Long T, Tafe LJ, Weck KE.

Genet Med. 2016 Dec;18(12):1206-1213. doi: 10.1038/gim.2016.34. Epub 2016 Apr 28.

PMID:
27124787
19.

A new generation of companion diagnostics: cobas BRAF, KRAS and EGFR mutation detection tests.

Angulo B, Lopez-Rios F, Gonzalez D.

Expert Rev Mol Diagn. 2014 Jun;14(5):517-24. doi: 10.1586/14737159.2014.910120. Review.

PMID:
24844134
20.

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