Advanced cancer patients are often unaware of the molecular features of their disease and the opportunity for entry into potentially life-saving clinical trials. There are currently hundreds of ongoing studies enrolling genetically-defined patient populations. In many cases, these targeted genetic alterations are rare (e.g. 1%) requiring 1,000 screened patients to identify 10 trial candidates. Most patients do not undergo routine tumor genome sequencing, so eligibility for such studies remains unknown to patients, all while providers and trial sponsors struggle to fully enroll studies in a timely manner, if at all.
The Strata Trial is an unprecedented and streamlined approach to accelerate precision medicine for cancer patients. The trial, a nationwide observational study providing no-cost tumor sequencing and clinical trial matching for 100,000 advanced cancer patients, aims to study the impact of sequencing on clinical trial enrollment. Our goal is to dramatically expand patient access to tumor sequencing and precision medicine trials, and to accelerate the approval of breakthrough cancer medicines. The Strata Trial provides tumor sequencing to all eligible cancer patients at no cost, and proactively matches patients to Strata's portfolio of affiliated pharma-sponsored clinical trials.
How does the Strata trial work?
- All late stage solid tumor and lymphoma patients at Strata Precision Oncology Network sites are eligible for screening.
- Eligible patients are consented and enrolled on the screening protocol.
- An archival FFPE tumor sample is shipped to Strata's CLIA laboratory for no-cost tumor sequencing.
- A report detailing tumor mutations and, if applicable, the matching trial is return to the provider.
- For patients with a matching trial, the provider screens the patient for additional eligibility criteria and may consent and enroll the patient on the protocol.
Detailed information about the Strata Trial is available at https://clinicaltrials.gov/ct2/show/NCT03061305.
Patients receive no-cost tumor sequencing and access to investigational therapies matched to the genomic profiles of their tumors.
Providers can expand access to precision medicine for advanced cancer patients and enhance critical research to better understand and treat cancer.
Pharmaceutical companies get access to biomarker-positive advanced cancer patients needed to increase trial enrollment to conduct transformative precision oncology clinical trials.
Strata Oncology Laboratory
High-throughput CLIA-certified cancer sequencing laboratory
Experienced cancer NGS laboratory team, led by pathologist and genome scientist Scott Tomlins, MD, PhD
- Capacity: 50,000 cases/ year
- Turn around time is less than 10 days
StrataNGS is a tumor sequencing test performed in Strata Oncology’s high-throughput CLIA-certified laboratory in Ann Arbor, MI. StrataNGS targets 87 genes by sequencing DNA and RNA from limited formalin-fixed paraffin-embedded tumor material. The test was designed to detect clinically actionable genetic variants for which there are associated approved therapies or clinical trials.
Results include Microsatellite instability (MSI) status, which may help predict response to immunotherapy.
The StrataNGS test was based in part on the Strata team's prior development and validation of the Oncomine Cancer Panel (1), which was also the basis for the National Cancer Institute's MATCH assay (2).
2. Lin CJ, et al. Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial. J Mol Diagn. 2017 Mar;19(2):313-327