Genetic Test Registry Finds Growth of Oncology, NGS-Based Tests

By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies

The number of cancer gene tests has grown tremendously in the past two years, particularly in the field of oncology where the number of tests grew by 156 percent, an abstract presented at the 2016 American Society of Clinical Oncology annual meeting (Chicago, June 2-6).

Researchers from the National Institutes of Health (NIH) conducted a landscape scan of test offerings as part of the Institutes’ Genetic Testing Registry (GTR). GTR is a free, publicly available website that intends to centralize access to comprehensive information about genetic tests. Test information is voluntarily submitted by providers, including the test’s purpose, methodology, validity, clinical utility, and laboratory contacts and credentials.

In the present study, NIH researchers compared GTR content of orderable genetic tests available in February 2014, 2015, and 2016. The database query included laboratory and test attributes such as methods, genes, and indications. They defined a gene panel as having more than four targets and a commonly tested gene as being in more than 99 tests.

The researchers found that as of February 2016, GTR had 32,969 tests for 5,996 conditions offered by 462 labs in 41 countries.* This is a 138 percent increase in test count over 24 months. For the oncology subset, there were 5,568 tests for tumors, hereditary cancer syndromes, and pharmacogenetics. Oncology represented 17 percent of all GTR tests and grew 153 percent over the previous 12 months. Cancer genes comprise more than one-third (29 out of 80) of the most commonly tested genes.

Interestingly, next-generation sequencing (NGS) methodology rose from 10 percent of molecular tests to 27 percent over 24 months. Of the 8,438 NGS tests, 79 percent report a single gene result, while panels comprise 16.4 percent (n=1,380) of NGS tests. In total, GTR has 156 NGS cancer gene panels that test between five and 112 genes.

“Cancer genes, panels, and NGS feature prominently in laboratory test offerings, writes lead author Wendy Rubinstein, M.D., Ph.D., director of the GTR. “A new phenomenon is the ability to selectively order one or more genes performed as part of a much larger NGS assay. The ordering clinician can thereby avoid reporting of markers that may be added to improve sensitivity but have unclear validity or utility.”

*G2 Intelligence more recently assessed the GTR database, and as of June 22, 2016, GTR included 46,420 tests from 472 laboratories for 10,411 conditions representing 4,948 genes.