Publications:
Klein RD. Daubert v. Merrell Dow: Scientific Evidence in the Courtroom. JAMA. 1994; 271:1578.
Yilmaz Y, Klein R, Qumsiyeh M. Trisomy 6 acquired in lymphoid blast transformation of CML with t(9;22). Cancer Genet Cytogenet. 2003; 145(1):86-7.
Klein RD, Howe J, Magriples U, McPhedran P. Eclampsia in a woman homozygous for the prothrombin G20210A mutation. Thromb and Haemost 2004; 91:201-202.
Klein RD, Salih S, Bessoni J, Bale AE. Clinical testing for multiple endocrine neoplasia type 1 in a DNA diagnostic laboratory. Genet Med 2005;7:131-138.
Klein RD, Campbell S, Howanitz PJ. CAP Point of Care Checklist Frequently Asked Questions. Point of Care 2005;4:75-85.
Klein RD, Dykas DJ, Bale AE. Clinical testing for the nevoid basal cell carcinoma syndrome (NBCCS) in a DNA diagnostic laboratory. Genet Med 2005;7:611-619.
Campbell S, Klein RD. Waived Tests and Testing. Clin Microbiol Newsl 2006;28:89-93.
Klein RD, Campbell S. Health Care Fraud and Abuse Laws. Arch Pathol Lab Med 2006;130:1169-1177.
Klein RD, Thorland EC, Gonzales PR, Beck PA, Dykas DJ, McGrath J, Bale AE.A multiplex assay for the detection and mapping of complex glycerol kinase deficiency. Clin Chem 2006;52:1864-1870.
Campbell S, Klein RD. HIV Testing At Home: Boon or Bane? J Clin Microbiol 2006;44:3473-3476.
Klein RD, Kant JA. Opportunity Knocks: The Pathologist as Laboratory Genetics Consultant. Arch Pathol Lab Med 2006;130:1603.
Klein RD. Medical-Process Patents, N Engl J Med 2007;356:753-754.
Klein RD. Gene Patents Jeopardize Genetic Testing. Genetic Engineering and Biotechnology News 2007; 27(9):12.
Klein RD. Hereditary Breast and Ovarian Cancer: The BRCA1 and BRCA2 Genes. NewsPath, May 2007. College of American Pathologists, Chicago, IL. Available at http://www.CAP.org.
Klein RD. The Pain-protective Haplotype: Introducing the Modern Genetic Test. Clin Chem 2007;53:1007-1009.
Klein RD, Mahoney MJ. Medical-Legal Issues in Prenatal Diagnosis. Clin Perinatol 2007;34:287-297.
Klein, RD. Gene Patents and Genetic Testing in the United States. RAJ Devices 2007;15:241-244.
Klein, RD. Gene Patents and Genetic Testing in the United States. RAJ Pharma 2007;18:531-534.
Klein RD. Gene Patents and Personalized Medicine. Personalized Medicine 2007;4:237-241.
Klein RD. Gene Patents and Genetic Testing. Adv Admin Lab 2007;16:18-20.
Klein, RD. Gene Patents and Genetic Testing in the United States. Nat Biotechnol 2007;25:989-990.
Klein RD. Gene Patents and Genetic Testing in the United States. Drug and Market Development 2007;18:26-28.
Klein RD, Mahoney MJ. LabCorp v. Metabolite Labs: The Supreme Court Listens, but Declines to Speak. J Law Med Ethics 2008;36:141-9.
Klein RD, Jin L, Rumilla K, Young WF, Lloyd RV. Germline SDHB mutations are common in patients with apparently sporadic sympathetic paragangliomas. Diagn Mol Pathol 2008;17:94-100.
Klein RD. Genetic Testing and Primary Care. JAMA 2008;299:2275.
Klein RD, Lloyd RV, Young WF. Hereditary Paraganglioma-Pheochromocytoma Syndromes. In: GeneReviews at GeneTests: Medical Genetics Information Resource (database online). Copyright, University of Washington, Seattle. 1997-2012. http://www.genetests.org
Erickson ML, Champion MH, Klein R, Ross RL, Neal ZM, Snyder EL. Management of Blood Shortages in a Tertiary Care Academic Medical Center: The Yale New Haven Hospital Frozen Blood Reserve. Transfusion 2008;48:2252-63.
Klein RD. Analysis: Secretary’s Advisory Committee on Genetics, Health, & Society Report falls short. Hum Pathol 2009;40:147-55.
Klein RD. Interview. Pharmacogenomics 2009;10:9-12.
Klein RD. Legal developments and practical implications of gene patenting on targeted drug discovery and development. Clin Pharmacol Ther 2010;87:633-5.
Klein RD, Marcucci G: Familial Acute Myeloid Leukemia (AML) with Mutated CEBPA (October 2010) in: GeneReviews at GeneTests: Medical Genetics Information Resource [database online]. Copyright, University of Washington, Seattle, 1997-2014. Available at http://www.genetests.org.
Klein RD. US court’s decision in AMP v USPTO advances personalised medicine. Regulatory Affairs Pharma, October 2010; 6-7.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: Does genomic profiling to assess CVD risk improve cardiovascular health? Genet Med 2011;12:839-43.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: Routine testing for factor V Leiden (R506Q) and prothrombin (20210G>A) mutations in adults with a history of venous thromboembolism and their adult family members. Genet Med 2011;13:67-76.
Association for Molecular Whole Genome Analysis Working Group. The Association for Molecular Pathology’s Approach to Supporting a Global Agenda to Embrace Personal Genomic Medicine. J Mol Diagn 2011;13:249-51.
Hall L, Wilson JA, Bernard K, Carbone MP, El Mubarak HS, Hallam SE, Klein RD, Pancholi P, Schoonmaker MM, Spector EB, Vitazka P, et al. Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline. CLSI document MM19-P. Wayne, PA; Clinical Laboratory Standards Institute 2011.
Klein RD. Gene Patents and Personalized Medicine. ASCO Educational Book 2012; 81-83.
Schrijver I, Aziz N, Farkas DH, Furtado M, Gonzalez AF, Greiner TC, Grody WW, Hambuch T, Kalman L, Kant JA, Klein RD, Leonard DG, Lubin IM, Mao R, Nagan N, Pratt VM, Sobel ME, Voelkerding KV, Gibson JS. Opportunities and Challenges Associated with Clinical Diagnostic Genome Sequencing: A Report of the Association for Molecular Pathology. J Mol Diagn 2012;14:525-40.
Veenstra DL, Piper M, Haddow JE, Pauker SG, Klein R, Richards CS, Tunis SR, Djulbegovic B, Marrone M, Lin JS, Berg AO, Calonge N. Improving the efficiency and relevance of evidence-based recommendations in the era of whole-genome sequencing: an EGAPP methods update. Genet Med 2013;15:14-24.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Calonge N, Fisher NL, Berg AO, Campos-Outcalt D, Djulbegovic B, Ganiats TG, Haddow JE, Klein RD, Lyman DO, Offit K, Pauker SG, Piper M, Richards CS, Strickland OL, Tunis SR, Veenstra DL. Recommendations from the EGAPP Working Group: can testing of tumor tissue for mutations in EGFR pathway downstream effector genes in patients with metastatic colon cancer improve health outcomes by guiding decisions regarding anti-EGFR therapy. Genet Med 2013;15:517-27.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Calonge N, Fisher NL, Berg AO, Campos-Outcalt D, Djulbegovic B, Ganiats TG, Haddow JE, Klein RD, Lyman DO, Offit K, Pauker SG, Piper M, Richards CS, Strickland OL, Tunis SR, Veenstra DL. Recommendations from the EGAPP Working Group: does genomic profiling to assess type 2 diabetes risk improve health outcomes? Genet Med 2013;15:612-7.
Klein RD. Molecular Diagnostics: Molecular Med Tri-Con 2013. Expert Rev Mol Diagn 2013;6:527-8.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Calonge N (Chair), Klein RD (Vice-chair), Berg AO, Berg JS, Armstrong K, Botkin J, Campos-Outcalt D, Djulbegovic B, Fisher NL, Ganiats TG, Haddow JE, Hayes M, Janssens AC, Kaye C, Lyman DO, Offit K, Pauker SG, Phillips KA, Piper M, Richards CS, Scott JA, Strickland OL, Teutsch S, Tunis SR, Veenstra DL, Williams MS, Zallen DT. The EGAPP Initiative: Lessons Learned. Genet Med 2014;16:217-24.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Calonge N (Chair), Klein RD (Vice-chair), Berg JS, Campos-Outcalt D, Djulbegovic B, Ganiats T, Janssens CJW, Offit K, Pauker SG, Piper M, Richards CS, Strickland OL, Tunis S, Williams MS, Zallen D. Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? Genet Med 2014;16:338-46.
Klein RD. AMP v. Myriad: The Supreme Court Gives a Win to Personalized Medicine. J Mol Diagn 2013;15:731-2.
Ferreira-Gonzalez A, Emmadi R, Day SP, Klees RF, Leib J, Lyon E, Nowak JA, Williams M, Pratt V, Klein RD. Revisiting Oversight and Regulation of Molecular-based Laboratory Developed-Tests: A Position Statement of the Association for Molecular Pathology. J Mol Diagn 2014;16:3-6.
Klein RD. Intellectual Property and Regulation of Molecular Pathology Tests. Cancer J 2014;20:85-90.
Lenk TJ, Lubin IM, Ross D, Bankowski MJ, Bennett SF, Burnham C, Duncavage EJ, Farwell LM, Feldblyum TV, Furtado MR, Getman DK, Hambuch TM, Klein RD, Platt JL, Ramamurthy L, Scheffer H, Stockley T, Vitazka P, Winn-Deen ES.
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline. CLSI document MM09-A. Wayne, PA; Clinical Laboratory Standards Institute 2014.
Schully SD, Lam TK, Dotson WD, Chang CQ, Aronson N, Birkeland ML, Brewster SJ, Boccia S, Buchanan AH, Calonge N, Calzone K, Djulbegovic B, Goddard KAB, Klein RD, Klein TE, Lau J, Long R, Lyman GH, Morgan RL, Palmer CGS, Relling MV, Rubinstein WS, Swen JJ, Terry SF, Williams MS, Khoury MJ. Evidence Synthesis and Guideline Development in Genomic Medicine: Current Status and Future Prospects. Genet Med 2015;17:63-7.
Klein RD. Reimbursement in Molecular Pathology: Bringing Genomic Medicine to Patients. Clin Chem 2015;61:136-8.
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Calonge N (Chair), Klein RD (Vice-chair), Berg JS, Campos-Outcalt D, Djulbegovic B, Ganiats T, Janssens CJW, Offit K, Pauker SG, Richards CS, Strickland OL, Tunis S, Williams MS, Zallen D. Recommendations from the EGAPP Working Group: Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer? Genet Med 2016;18:770-9.
Klein, RD. New approaches to molecular pathology testing in advanced lung cancer, Pathology Innovations, Cleveland Clinic, Fall 2015.
Joseph L, Cankovic M, Caughron S, Chandra P, Emmadi R, Hagenkord J, Hallam S, Jewell KE, Klein RD, Leib J, Nowak J, Pratt VM, Rothberg P, Temple-Smolkin R, Lyon E, Association for Molecular Pathology’s Framework for the Evidence Needed to Demonstrate Clinical Utility Task Force. Framework for Addressing Clinical Utility of Molecular Diagnostic Testing: A Report of the Association of for Molecular Pathology. J Mol Diagn 2016;18:605-19.
Reynolds J, Zhou Y, Jakubowski M, Wang Z, Brainard J, Klein R, Farver C, Almeida F, Cheng Y. Next-Generation Sequencing of Liquid-based Cytology Non-small Cell Lung Cancer Samples. Cancer Cytopathol 2017;125:178-87.
Conley RB, Dickson D, Zenklusen JC, Al Naber J, Messner D, Atasoy A, Chaihorsky L, Collyar D, Compton C, Ferguson M, Khozin S, Klein RD, Kotte S, Kurzrock R, Lin CJ, Liu F, Marino I, McDonough R, McNeal A, Miller V, Schilsky RI, Wang LI. Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus. Cell 2017;171:982-986.
Klein RD. Current Policy Challenges in Genomic Medicine. Clin Chem (e-publication ahead of print, November 8, 2019).
Book Chapters
Klein RD and Edberg SC. Applications, Significance of and Methods for the Measurement of Antimicrobial Concentrations in Human Body Fluids. In: Lorian V. ed. Antibiotics in Laboratory Medicine. 5th ed. Baltimore, MD: Williams & Wilkins 2005.
Zhang L and Klein R. Pathogenesis of Non-Hodgkin Lymphoma Derived from Infectious Diseases. In: Tao J and Sotomayor E. eds. Hematologic Cancers: From Molecular Pathology to Targeted Therapeutics (Cancer Growth and Progression). New York: Springer 2012.
Klein RD. Legal Issues. In: Pfeifer J, Kulkarni S eds. Clinical Genomics: A Guide to Clinical Next Generation Sequencing. Boston, MA: Elsevier 2014.
Klein RD. Patents and Proprietary Assays. In: Netto G, Schrijver I eds. Genomic Applications in Clinical and Anatomic Pathology. New York NY: Springer 2015.
Klein RD. Patents and Proprietary Assays. In: Netto G, Schrijver I eds. Genomic Applications in Clinical and Anatomic Pathology. New York NY: Springer 2019.