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IPM: What makes the Strata Oncology molecular profiling platform unique?
From the beginning, we’ve been laser-focused on bringing about a world in which each and every patient with cancer is treated with their best possible therapy. That’s why we built our platform operformancen multiplex PCR-based next-generation sequencing (NGS) technology ideally suited to delivering clinical-grade . Other companies in this space have instead relied on hybrid capture-based technology.
With our platform, we simultaneously sequence DNA and RNA to analyze all guideline-recommended genes and emerging biomarkers in solid tumors (not just hotspots). We candetect all classes of genomic variants, microsatellite instability (MSI), and tumor mutational burden (TMB), and we do it all with high sensitivity, high reliability, and ultra-low input requirements. Our sample requirement is just 2mm2 or greater tumor surface area (TSA).
IPM: Why is it important that the Strata Oncology platform performs well on small tissue samples?
When it comes to making precision treatment the standard of care for all patients with cancer, tissue is the issue. Conventional comprehensive genomic profiling (CGP) tests that rely on hybrid capture-based sequencing require samples with TSA of 25mm2 or more. We published data in 2021 showing that in a real-world series of more than 30,000 consecutive samples, approximately 59% of patients missed this threshold.1
Because our platform requires less than 1/10th the sample size of conventional tests, 93% of patients in that study met our input requirements (and we were able to deliver informative results for
many samples that came in under 2mm2 too).
If physicians know one thing about our CGP test, I want it to be that if there’s sufficient tissue to make a diagnosis, there is virtually always sufficient tissue for molecular profiling through Strata Oncology.
IPM: Is liquid biopsy a suitable alternative when the available tissue sample is small?
Measuring circulating tumor DNA (ctDNA) in blood can be a powerful tool for recurrence detection and/or treatment monitoring, but when it comes to understanding the molecular characteristics of a patient’s cancer in order to determine their optimal therapy, reduced sensitivity of CGP tests based on liquid biopsy limit its clinical application.
For example, studies have shown that in non-small cell lung cancer (NSCLC), 25% of actionable EGFR variants are missed by liquid biopsy.2 Similarly, in prostate cancer, approximately 21% of actionable variants in BRCA1/BRCA2/ATM are missed.3 Because of this reduced sensitivity, both of the FDA-approved liquid biopsy tests require negative results for the companion diagnostic biomarkers to be reflexed to tissue testing when feasible.2, 3 Importantly, our study showed there is nearly always sufficient tissue for analyzing these and other CGP biomarkers using our test.1
We think patients and physicians are best served by starting with tissue and using a testing platform that works for virtually every sample.
IPM: Beyond superior small sample performance, what else differentiates the Strata Oncology platform?
Strata Oncology’s comprehensive treatment guidance platform is setting a new standard for molecular testing.
We’re going beyond genomics. With our quantitative RNA expression algorithms and novel predictive biological signatures, we’re going to provide rapid, actionable insights from a single tissue sample that enable confident clinical decision-making across the cancer care continuum and for the full range of therapeutic modalities.
Because when it comes to cancer care, information is power.
References
- Tomlins et al. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021;5:1312-1324
- Guardant360® CDx Technical Information (Accessed 09-21-21)
- FoundationOne® Liquid CDx (F1 Liquid CDx) SSED. (Accessed 09-22-21)
Strata Oncology is a precision oncology company committed to accelerating the impact of precision medicine for patients with cancer.
For additional information: www.strataoncology.com