HTG EdgeSeq ALKPlus Assay EU for ALK status testing in non-small-cell lung cancer

Level of innovation

All 3 commentators thought that the test was novel. One noted that it was differentiated from other methods of ALK status testing through the patient report and hands-off approach. Another specialist noted that minimal lung tissue (that is, stored FFPE specimens) was needed for testing.

Potential patient impact

One commentator noted that HTG EdgeSeq ALKPlus Assay EU represents testing closer to the point of care than other methods of ALK status testing. Another felt that the assay could help standardise ALK status testing, and pointed out that it does not need another lung biopsy to be done. In contrast the third commentator felt that the test did not offer any advantages over other methods of testing.

One specialist commentator noted that once a MiSeq system is procured, it can be used in many pathways. Another stated that this test might have a higher detection rate than FISH, but that this is unlikely to be the case with IHC. One commentator felt that the test could lead to more accurate prediction of response to crizotinib, but another stated that there was no evidence to predict any potential impact.

Potential system impact

One commentator stated that ALK status testing is already adequate in practice. They noted that there may be cost savings through less reporting consultant time, but that any savings would be small compared with the increased cost per test. Another specialist observed that the test's reproducibility could benefit the NHS, as well as its reduced need for interpretation. One commentator noted that using the test would mean more sample transfers between testing centres, because not every centre has its own machine. Two specialist commentators agreed that the test would be cost incurring for the NHS.

General comments

Two commentators noted that next-generation sequencing (such as that done by HTG EdgeSeq ALKPlus Assay EU) generates a large amount of data, which may represent a substantial IT service commitment for data storage and maintenance.

One specialist noted that the research-use-only full patient report of multiple mutations may be useful if it can be validated internally by laboratories.