Current and future trends in non–small cell lung cancer biomarker testing: The American experience

Abstract

Biomarker testing in patients with advanced stage non–small cell lung cancer provides essential information that can be used to select the most appropriate therapy. The regular updates of guideline recommendations reflect the growing number of biomarkers that must be assessed, and as such signal the shift from single‐gene assays to more comprehensive genomic profiling using next‐generation sequencing modalities. Cytology and small biopsy specimens have proven to be more than adequate substrates for these types of ancillary molecular testing; however, other alternative testing substrates are beginning to emerge. These include so‐called liquid biopsies as well the supernatant fluid from cytology specimens, both of which have demonstrated promise for use in the clinical realm. This review will briefly cover the current state of non–small cell lung cancer biomarker testing in the United States, with a focus on these novel nonconventional substrates that are increasingly being incorporated into testing paradigms.

Molecular diagnosis in non-small-cell lung cancer: expert opinion onALKandROS1testing

“…Cytological smears fixed in alcohol or an alcoholic solution are suitable in protocols aimed at biomarker determination. [8][9][10] National and international guidelines recommend, when possible, creating cell blocks for subsequent paraffin processing. This facilitates the application of similar protocols as those of tissue biopsies.…”

Budget impact of tepotinib in the treatment of adult patients with metastatic non-small cell lung cancer harboring METex14 skipping alterations in the United States

“…Testing rates were derived from market research conducted by EMD Serono, [31] and driven by the anticipation that testing is likely to become increasingly common over time due to A c c e p t e d M a n u s c r i p t advances in testing capabilities, the proliferation of new treatments, and changing general attitudes among healthcare practitioners toward the utility of testing in the context of treatment for NSCLC. [32] As such, testing rates of 49%, 75%, and 85% were applied in the base-case analysis for years 1, 2 and 3, respectively. Alternative assumptions around testing were explored as scenario analyses.…”

“…Given technological progress in the diagnostics space, continuous increases in testing capacities, and a general trend toward increasing acceptance of testing as a tool for guiding optimal therapeutic decision-making, [32] a scenario assuming higher testing rates was conducted. This scenario assumed testing rates to be up to 20% higher than the base-case, capped at 100% (i.e., 59% vs. 49% [base-case] in year 1, 90% vs. 75%…”

Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies: Guidelines from the College of American Pathologists (CAP)

“…In an era of predictive oncology and precision medicine, pathologists are keenly aware of the need to collect adequate tissue not only to arrive at a diagnosis but also to provide predictive and prognostic information that would guide patient care [1][2][3][4][5]. This is especially true in the realm of non-small cell lung cancer (NSCLC), where biomarker testing is routinely used for the clinical management of patients with advanced stage disease [5][6][7][8]. The list of clinically relevant biomarkers in NSCLC is constantly expanding.…”