Journal Article
. 2010 Nov;28(11).
doi: 10.1038/nbt1110-1157.

A policy approach to the development of molecular diagnostic tests

Kevin A Schulman 1 Sean R Tunis  
Affiliations
  • PMID: 21057480
  •     13 References
  •     3 citations

Abstract

Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.

Ethical and scientific implications of the globalization of clinical research.
Seth W Glickman, John G McHutchison, +4 authors, Kevin A Schulman.
N Engl J Med, 2009 Feb 21; 360(8). PMID: 19228627
Highly Cited.
Parity, oral contraceptives, and the risk of ovarian cancer among carriers and noncarriers of a BRCA1 or BRCA2 mutation.
B Modan, P Hartge, +10 authors, National Israel Ovarian Cancer Study Group.
N Engl J Med, 2001 Jul 28; 345(4). PMID: 11474660
A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer.
Anil Potti, Sayan Mukherjee, +10 authors, Joseph R Nevins.
N Engl J Med, 2006 Aug 11; 355(6). PMID: 16899777
Highly Cited.
The prognostic role of a gene signature from tumorigenic breast-cancer cells.
Rui Liu, Xinhao Wang, +7 authors, Michael F Clarke.
N Engl J Med, 2007 Jan 19; 356(3). PMID: 17229949
Highly Cited.
Economic implications of potential changes to regulatory and reimbursement policies for medical devices.
Shelby D Reed, Alisa M Shea, Kevin A Schulman.
J Gen Intern Med, 2008 Jan 10; 23 Suppl 1. PMID: 18095045    Free PMC article.
Coverage options for promising technologies: Medicare's 'coverage with evidence development'.
Sean R Tunis, Steven D Pearson.
Health Aff (Millwood), 2006 Sep 13; 25(5). PMID: 16966717
Why Medicare has not established criteria for coverage decisions.
Sean R Tunis.
N Engl J Med, 2004 May 21; 350(21). PMID: 15152066
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
Oncogenic pathway signatures in human cancers as a guide to targeted therapies.
Andrea H Bild, Guang Yao, +12 authors, Joseph R Nevins.
Nature, 2005 Nov 08; 439(7074). PMID: 16273092
Highly Cited.
Gene expression signatures, clinicopathological features, and individualized therapy in breast cancer.
Chaitanya R Acharya, David S Hsu, +15 authors, Anil Potti.
JAMA, 2008 Apr 05; 299(13). PMID: 18387932
Fueling innovation in medical devices (and beyond): venture capital in health care.
D Clay Ackerly, Ana M Valverde, +2 authors, Kevin A Schulman.
Health Aff (Millwood), 2008 Dec 04; 28(1). PMID: 19049999
Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose.
Mark J Rieder, Alexander P Reiner, +7 authors, Allan E Rettie.
N Engl J Med, 2005 Jun 03; 352(22). PMID: 15930419
Highly Cited.
Pharmacogenomics--drug disposition, drug targets, and side effects.
William E Evans, Howard L McLeod.
N Engl J Med, 2003 Feb 07; 348(6). PMID: 12571262
Highly Cited.
Overhauling the reimbursement system for molecular diagnostics.
Nafees N Malik.
Nat Biotechnol, 2011 May 10; 29(5). PMID: 21552233
Cancer biomarkers: selecting the right drug for the right patient.
Gary J Kelloff, Caroline C Sigman.
Nat Rev Drug Discov, 2012 Feb 11; 11(3). PMID: 22322254
Highly Cited. Review.
How much diagnostic safety can we afford, and how should we decide? A health economics perspective.
David E Newman-Toker, Kathryn M McDonald, David O Meltzer.
BMJ Qual Saf, 2013 Oct 31; 22 Suppl 2. PMID: 24048914    Free PMC article.