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Launch of Moffitt STAR* Assay Shines Light on Cancer
By Dr. Theresa Boyle
The study of genetic changes in cancer tissue moved from the lab bench to clinical testing decades ago. With the advent of "next generation sequencing (NGS)" technology, otherwise known as "massively parallel sequencing," the amount of genetic information that can be derived from a small amount of cancer tissue has increased dramatically. Clinical testing has advanced from testing of just one location of one gene at a time for only the most clinically important changes to simultaneous and comprehensive testing of hundreds of genes for both clinically important as well as less well understood changes at a historically low cost.
In February, 2018, the Morsani Advanced Diagnostics Laboratories at the Moffitt Cancer Center launched the Moffitt STAR* (Solid Tumor Actionable Result) panel. This panel is based on the Illumina TruSight™ Tumor 170 (TST170) assay which is a next-generation sequencing assay designed to cover 170 genes that are commonly designated as drivers in solid tumors. The assay evaluates both DNA and RNA and focuses on detecting actionable gene changes (mutations), such as small variants, large deletions and insertions, gene amplifications, fusions and splice variants. The development and the launch of Moffitt STAR* was made possible through collaboration with industry partners, Illumina Inc and PierianDx (bioinformatics support).
The launch of the Moffitt STAR* genetic assay in February was much needed because of the many FDA-approved targeted therapies which are proven by clinical trials to be better than other therapies, but only if matched to patients with cancers that harbor specific genetic changes. These targeted therapies include FDA-approved therapies for lung cancers with EGFR, ALK, ROS1, and BRAF mutations. Furthermore, a subset of patients with lung cancers with a high number of mutations (high tumor mutation burden) may have a better chance of responding to immunotherapy.
Many key actionable mutations only occur rarely, such as NTRK gene fusions, and there often is not enough tissue or assays available to test for these rare mutations one at a time. The Moffitt STAR* assay now allows the molecular laboratory to screen patient tumors comprehensively for numerous genetic changes in 170 genes efficiently in a single test using a relatively small amount of tissue. This important advance enables evaluation of patients for eligibility to receive treatment with a FDA approved targeted therapy, or to be considered for clinical trial enrollment. Moffitt STAR* is essentially an “all in one” test that provides information about well-known clinically actionable changes and also detects other genetic changes that might not be actionable immediately, but could be helpful later. Work is in progress to prove that this assay is also capable of reliably detecting tumor mutational load and microsatellite instability, indicators of a higher likelihood of response to immunotherapy. Once this work is complete, even more information will be included on the Moffitt STAR* report. Since the launch of Moffitt STAR* in February, cancer specimens from over 300 patients have been tested.