Study to Evaluate Strata’s Ability to Detect Tumor Recurrence using Liquid Biopsy and Monitor Treatment Effectiveness for Patients with Early-Stage Solid Tumors

Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced plans to begin enrolling the Sentinel Trial in the first half of 2021. Sentinel is a prospective, observational study designed to enroll approximately 100,000 patients diagnosed with stage 1-3 solid tumors and indicated for surgery or definitive therapy. The study will evaluate the ability of Strata’s investigational liquid biopsy assay to detect disease recurrence and to monitor treatment effectiveness in patients across solid tumors.

“The Sentinel Trial will support the validation of our personalized recurrence monitoring assay for patients with solid tumors in a diverse population,” said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. “The study will also evaluate the utility of our approach for guiding treatment decisions in patients with early-stage solid tumors. To date, most advances in precision oncology have been in late-stage cancer. The clinical and molecular information generated in this study has the potential to advance precision cancer care to the early-stage.”

The Sentinel Trial will pair simultaneous DNA and RNA tissue-based molecular profiling with liquid biopsy-based recurrence monitoring. Study participants will receive the StrataNGS comprehensive genomic profiling test upfront to identify a personalized mutation profile and a treatment selection profile. Results will inform custom design of a personalized liquid biopsy test to detect tumor-specific genomic alterations with high clinical sensitivity and specificity.

Strata Oncology recently made StrataNGS^TM broadly available in the U.S. based on its experience processing more than 40,000 tissue specimens from patients with advanced cancer through the Strata Trial. Recent data showed that the StrataNGS test’s performance on small tumor tissue samples may provide treatment selection results for 50% more patients than other leading tumor profiling tests.

About StrataNGS

StrataNGS is a comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements in the industry (>2mm² surface area). The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.