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Diagnostics 2016, 6(1), 4; doi:10.3390/diagnostics6010004

Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer

1
Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USA
2
Ernest Mario School of Pharmacy, Rutgers University, 160 Frelinghuysen Rd, Piscataway Township, NJ 08854, USA
3
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA
4
UT Southwestern Medical Center, 2330 Inwood Road, Dallas, TX 75235, USA
5
Penn Presbyterian Medical Center, Department of Pathology, Philadelphia, PA 19104, USA
6
The Pathological Institute Celle, Wittinger Str. 14, 29223 Celle, Germany
7
Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Zhen Cheng
Received: 24 November 2015 / Revised: 28 December 2015 / Accepted: 29 December 2015 / Published: 6 January 2016
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Abstract

Identification of alterations in ALK gene and development of ALK-directed therapies have increased the need for accurate and efficient detection methodologies. To date, research has focused on the concordance between the two most commonly used technologies, fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). However, inter-test concordance reflects only one, albeit important, aspect of the diagnostic process; laboratories, hospitals, and payors must understand the cost and workflow of ALK rearrangement detection strategies. Through literature review combined with interviews of pathologists and laboratory directors in the U.S. and Europe, a cost-impact model was developed that compared four alternative testing strategies—IHC only, FISH only, IHC pre-screen followed by FISH confirmation, and parallel testing by both IHC and FISH. Interviews were focused on costs of reagents, consumables, equipment, and personnel. The resulting model showed that testing by IHC alone cost less ($90.07 in the U.S., $68.69 in Europe) than either independent or parallel testing by both FISH and IHC ($441.85 in the U.S. and $279.46 in Europe). The strategies differed in cost of execution, turnaround time, reimbursement, and number of positive results detected, suggesting that laboratories must weigh the costs and the clinical benefit of available ALK testing strategies. View Full-Text
Keywords: Anaplastic lymphoma kinase (ALK) gene rearrangement; immunohistochemistry (IHC); fluorescent in situ hybridization (FISH); non-small cell lung cancer (NSCLC); cost-impact model Anaplastic lymphoma kinase (ALK) gene rearrangement; immunohistochemistry (IHC); fluorescent in situ hybridization (FISH); non-small cell lung cancer (NSCLC); cost-impact model
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Doshi, S.; Ray, D.; Stein, K.; Zhang, J.; Koduru, P.; Fogt, F.; Wellman, A.; Wat, R.; Mathews, C. Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer. Diagnostics 2016, 6, 4.

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