Strata Oncology, Inc. (“Strata”), a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced the launch of Strata Select^TM, a first-of-its-kind molecular profiling test for patients with advanced cancer. The new diagnostic test features the Immunotherapy Response Score, a novel multivariate predictive biomarker algorithm for anti-PD-1/PD-L1 checkpoint inhibitor immunotherapy benefit.

Strata Select is available immediately for clinical use and is the first immunotherapy biomarker algorithm to be covered by Medicare across solid tumors meeting specified coverage criteria. The diagnostic test received a positive coverage determination from Palmetto MolDX under the policy “Next-Generation Sequencing for Solid Tumors.” 

“Strata Oncology’s mission is to provide oncologists and patients with precise, actionable insights for more personalized and effective cancer treatments,” said Dan Rhodes, PhD, co-founder and CEO of Strata Oncology. “Medicare coverage for our groundbreaking Strata Select test marks a significant milestone in our pursuit to deliver precision immunotherapy, empowering oncologists to make better-informed treatment decisions and enhance patient outcomes.”

The Immunotherapy Response Score integrates relevant biological factors (TMB, PD-L1, PD-1, and tumor microenvironment components) into a simple score to predict immunotherapy benefit across all solid tumors. Validation of the Immunotherapy Response Score was published earlier this year in Communications Medicine, with additional data presented at the 2023 AACR Annual Meeting and planned for presentation at the 2023 ASCO Annual Meeting. 

“Currently, there are patients who could greatly benefit from immunotherapy but never receive the opportunity, while others undergo treatment with little chance of success. Additionally, some patients receive a combination of immunotherapy and chemotherapy, when immunotherapy alone could be equally effective,” said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. “Strata Select addresses these challenges and empowers physicians to confidently treat patients likely to respond to immunotherapy, while avoiding ineffective treatment for those unlikely to benefit.”