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- Title
Comparison of Test Results for IHC, FISH and NGS when Screening for Molecular Markers.
- Authors
Janssen, Adam; Thuy Nguyen; Block, Miriam; Magharyous, Hany; Christiansen, Jason; Lamoureux, Jennifer
- Abstract
A consequence of personalized medicine is that as the number of potential therapies that target uncommon molecular variant markers grows, clinical testing is faced with the challenge of accurately stratifying patients for therapy. An example of these rare alterations are gene rearrangements, such as those found in the NTRK, ROS1 and ALK genes. This effort can be confounded by the fact that in small patient populations (e.g., for targeted kinase inhibitor therapies) the prevalence in a patient population can be as little as ~1-10%. Rare patient populations like this make the development of testing platforms challenging due the limited availability of materials. A number of testing methods can be employed by a laboratory depending on their volume and cost. Immunohistochemistry (IHC) is both high throughput and cost efficient, but is not specific to rearrangements. Fluorescence in situ hybridization (FISH), while currently the most common diagnostic detection of gene rearrangements, does not provide information regarding the gene fusion partner, while Next Generation Sequencing (NGS) is expensive and labor intensive. We have compared the clinical testing results from a combination of FISH and IHC testing to NGS testing. These results were generated from a subset of patients prospectively enrolled in a phase 1 clinical trial of the targeted therapy, entrectinib (n=23). Entrectinib targets tumors who harbor gene rearrangements in NTRK, ROS1 and ALK The outcome results demonstrate that testing by RNA based NGS testing is more predictive of patient response (ORR=66.7%) than FISH/IHC alone (38.5%). These results provide important information as the detection of gene rearrangements moves from the clinical trial setting to routine practice.
- Publication
Clinical Laboratory Science, 2017, Vol 31, Issue 3, p165
- ISSN
0894-959X
- Publication type
Academic Journal