Expert review of molecular diagnostics
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Expert Rev. Mol. Diagn. · Jan 2016
ReviewLung cancer screening: utility of molecular applications in conjunction with low-dose computed tomography guidelines.
Finding early-stage lung cancer where there is a higher chance for patient survival remains a major healthcare challenge. Low-dose spiral computed tomography for high-risk patients can increase the detection of cancers with certain tradeoffs, such as increased radiation exposure and surgical risks for false-positive cases. New molecular markers and assays show considerable promise to further reduce healthcare costs and improve lung cancer survival rates but require further validation. This review summarizes and discusses the current state of research in lung cancer screening and highlights developments in biomarker research for lung cancer diagnostics.
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Expert Rev. Mol. Diagn. · Jan 2016
EditorialCompanion diagnostic assays for PD-1/PD-L1 checkpoint inhibitors in NSCLC.
The immune checkpoint inhibitors pembrolizumab and nivolumab together with their diagnostic assays have recently been granted market authorization for treatment of advanced non-small-cell lung cancer in the USA. The two assays, PD-L1 IHC 22C3 pharmDx and PD-L1 IHC 28-8 pharmDx (both by Dako, Glostrup, Denmark), are the first PD-L1 IHC assays to obtain regulatory approval through the Premarket Approval process. ⋯ These diagnostic assays are able to identify the group of non-small-cell lung cancer patients who will benefit most from treatment with the immune checkpoint inhibitors. However, so far, it is only the PD-L1 IHC 22C3 pharmDx assay, which is linked to the use of pembrolizumab, that has obtained regulatory status as a companion diagnostic.