Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced results from validation studies demonstrating the reliable performance of the StrataNGS test were published in The Journal of Molecular Diagnostics. StrataNGS is a 429-gene, multiplex PCR-based comprehensive genomic profiling (CGP) test performed on co-isolated DNA and RNA from formalin-fixed paraffin-embedded (FFPE) tissue tumor specimens with >2mm² tumor surface area.

Through a unique assay configuration and novel bioinformatics pipeline optimized for multiplex PCR-based sequencing, StrataNGS demonstrated high sensitivity and specificity for detecting single nucleotide variants, insertions/deletions, gene fusions, copy number alterations, microsatellite instability and tumor mutation burden. Designed to provide comprehensive assessment of clinically actionable biomarkers from minute FFPE solid tumor tissue samples, StrataNGS substantially increases patient access to tissue-based CGP. A recent study of >30,000 real-world tumor tissue samples received for CGP found that only 41.6% of samples met minimum tissue requirements (>25mm² tumor surface area) for several leading hybrid capture-based CGP tests.

“StrataNGS demonstrated the sensitivity and specificity required for routine clinical practice while reporting all CGP variant classes from minute FFPE tissue samples,” said Scott Tomlins, M.D., Ph.D., co-founder and Chief Medical Officer, Strata Oncology. “Conventional tissue-based CGP and liquid biopsy tests often fail to meet either the sensitivity or success rate needed to deliver reliable results for each patient. StrataNGS nearly eliminates the insufficient tissue problem, while delivering the sensitivity required to confidently rule-in or out a treatment. This approach directly translates into treatment insights for more patients.”

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.