What does it take to create a competitive companion diagnostic? Bharathi Vennapusa outlines her role in the development and approval of the ALK CDx – a fully-automated immunohistochemistry assay that identifies lung cancer patients who may be eligible for treatment with crizotinib.
- A career in industry can be hugely rewarding for pathologists, especially with the rising interest in companion diagnostics
- Working to develop the ALK CDx assay, Bharathi Vennapusa explains how regulators are rethinking their strategy to encourage personalized therapy and diagnostic approvals
- Challenges remain to developing a good companion diagnostic, though, including difficulty in procuring tissue and reimbursement
- But there continues to be substantial growth in the field which, in the future, is likely to see more multiplexing and digital solutions
Bharathi Vennapusa is Director Clinical Operations at Ventana Medical Systems, Tucson, USA.
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References
- M Soda et al., “Identification of the transforming EML4-ALK fusion gene in non-small cell lung cancer”, Nature, 448, 561-566 (2007). PMID: 17625570. DW Kim et al., “Results of a global phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC)”, J Clin Oncol, 30, 7533 (Suppl) (2012).
