More than double the number of tumor tissue samples met the minimum tumor surface area requirement for comprehensive genomic profiling testing using Strata Oncology’s next-generation assay compared to other leading commercial tumor profiling tests, according to research published in JCO Precision Oncology on August 19.
Study findings demonstrate that the StrataNGS test can substantially increase patient access to tissue-based tumor profiling.
Medical Oncologists Michael Guarino, M.D, and Jamil Khatri, M.D., of the Helen F. Graham Cancer Center & Research Institute at ChristianaCare were co-authors of the study.
The Graham Cancer Center has partnered with Strata Oncology since 2018 to offer next-generation tumor profiling to patients with advanced or rare cancers. Based on test results, eligible patients are matched to the best available clinical trials or most innovative therapy.
As of June 1, 2021, 2,793 cancer patients have had their tumors profiled with 784 patients matched to a precision oncology therapy and 625 patients having their tumors matched to open clinical trials.
“We are excited that this study shows that more of our patients can benefit from the opportunity to participate in precision medicine clinical trials without leaving the state of Delaware,” said Dr. Guarino.
“This technology can successfully analyze the genome of more tumor tissue samples and that enables us to target more cancers with specific therapies, hopefully resulting in better outcomes for more patients.”
About the study
Study investigators at the Graham Cancer Center and at 27 other U.S. health systems analyzed more than 30,000 real-world tumor samples received for comprehensive genomic profiling and the performance of the StrataNGS test.
Key findings from the study include:
Of the 31,165 tested specimens, 10.7% had low (<20%) tumor content and 58.4% were small (<25mm2 tumor surface area). Additionally, 31.8% of samples had less than or equal to 10mm2 tumor surface area, including 10.7% with less than 2mm2 tumor surface area.
Only 41.6% of samples (12,957 of 31,165) had tumor surface greater than or equal to 25mm2, the minimum tumor surface requirement for several leading commercial hybrid capture-based comprehensive genomic profiling tests.
94% of samples (29,302 of 31,165) were successfully reported by StrataNGS.
“Tissue availability is one of the biggest obstacles to widespread use of comprehensive genomic profiling in clinical practice,” said lead author Scott Tomlins, M.D., Ph.D., who is co-founder and chief medical officer of Strata Oncology.
“For example, approximately 30% of patients with advanced non-small cell lung cancer have insufficient tissue for biomarker analysis.
“Despite advances in liquid biopsy testing, tissue remains the gold standard for tumor profiling, providing more comprehensive and reliable molecular insights.
“Through this study, we were able to show that StrataNGS, with its industry-leading low tumor tissue requirements, is uniquely positioned to help usher in a future where every patient with advanced cancer is molecularly profiled and receives their best possible treatment outcome.”
Tumor profiling requires a sample of the tumor tissue, either banked or from a new biopsy if that is part of the standard of care. Once Strata Oncology completes genome sequencing, a report detailing tumor mutations is sent to the Graham Cancer Center’s multidisciplinary team of experts for review.
If appropriate, the team matches the patient to an open clinical trial or recommends other therapeutic options. Patients who match to a clinical trial are further screened according to Institutional Review Board and trial eligibility criteria. Not all patients whose tumors are profiled match to a clinical trial.