Economic analysis of alternative strategies for detection of ALK rearrangements in non small cell lung cancer

Shivang Doshi, David Ray, Karen Stein, Jie Zhang, Prasad Koduru, Franz Fogt, Axel Wellman, Ricky Wat, Charles Mathews

Research output: Contribution to journalArticle

14 Scopus citations

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.

Original languageEnglish (US)
Article number4
JournalDiagnostics
Volume6
Issue number1
DOIs
StatePublished - Mar 1 2016

Keywords

  • Anaplastic lymphoma kinase (ALK) gene rearrangement
  • Cost-impact model
  • Fluorescent in situ hybridization (FISH)
  • Immunohistochemistry (IHC)
  • Non-small cell lung cancer (NSCLC)

ASJC Scopus subject areas

  • Clinical Biochemistry

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