Study shows StrataNGS substantially increases patient access to tissue-based comprehensive genomic profiling

Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced the publication of a new peer-reviewed study in which more than double the number of tumor tissue samples met minimum tumor surface area (TSA) for StrataNGS- a PCR-based comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements of any CGP test – versus other leading commercial hybrid capture-based CGP tests.

This new study published in JCO Precision Oncology presents an analysis of 32,048 consecutive tumor tissue samples received for StrataNGS testing as part of the Strata Trial. The study demonstrates that the multiplex PCR-CGP StrataNGS assay, coupled with an inclusive exception testing policy, can increase patient access to CGP and significantly expand the impact of biomarker-guided targeted and immunotherapies.

About the Study

In this study, investigators across 28 U.S. health systems characterized the attributes of >30,000 real-world tumor samples received for CGP and the performance of StrataNGS – which assesses all CGP variant classes – as applied to consecutively received and tested samples.

Key findings from the study include:

• Of the 31,165 tested specimens, 10.7% had low (less than 20%) tumor content and 58.4% were small (<25mm² TSA). Additionally, 31.8% of samples had less than or equal to 10mm² TSA, including 10.7% with less than 2mm² TSA.
• Only 41.6% of samples (12,957 of 31,165) had TSA greater than or equal to 25mm², the minimum TSA requirement for several leading commercial hybrid capture-based CGP 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 CGP in clinical practice.  For example, approximately 30% of patients with advanced non-small cell lung cancer have insufficient tissue for biomarker analysis.” said Scott Tomlins, M.D., Ph.D., co-founder and Chief Medical Officer, Strata Oncology. “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.”  

About the Study

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.