Regulating Laboratory-Developed Tests

Author:

O'Leary Timothy J.

Publisher

Elsevier BV

Subject

Molecular Medicine,Pathology and Forensic Medicine

Reference19 articles.

1. Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a PL100-578 (1988)

2. Executive Order 13563: Improving Regulation and Regulatory Review. Signed: January 18, 2011. Federal Register: 76 FR 3821, January 21, 2011

3. Kutz G. Direct-to-consumer genetic tests. Misleading test results are further complicated by deceptive marketing and other questionable practices. Washington (DC): Government Accountability Office (US); 2010. Report No.: GAO-10-847T

4. Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening;Naryshkin;Drug Healthc Patient Saf,2012

5. Retraction–Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial;Bonnefoi;Lancet Oncol,2011

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