Strata Oncology Announces Launch And Medicare Coverage For Strata Select, A First-Of-Its-Kind Immunotherapy Test

New diagnostic test stratifies the likelihood of immunotherapy benefit across solid tumors

Ann Arbor, MI /PRNewswire/ - Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced the launch of Strata Select™, 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 Ph.D., 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."

About Strata Oncology
Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and a large-scale clinical trial platform to identify and deliver optimal treatments for patients with cancer. For more information visit strataoncology.com.

About Strata Select
Strata Select is a pan-solid tumor molecular profiling test for patients with advanced cancer. Strata Select combines simultaneous DNA and quantitative RNA sequencing from a single small tumor tissue sample to provide treatment selection guidance for immunotherapy as well as other classes of therapy. Immunotherapy response prediction is based on the Immunotherapy Response Score, a proprietary, validated pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit. Strata Select also provides genomic signatures – tumor mutational burden (TMB) and microsatellite instability (MSI) -- and comprehensive genomic profiling results. Supplemental RNA expression-based results provide insights that can be informative for other classes of therapy, such as antibody-drug conjugates. All Strata Select reports are accompanied by a Strata Oncology Testing Summary, which is a concise, consolidated view of each patient's results and associated therapies. Learn more about Strata Select here.