SAN FRANCISCO (GenomeWeb) – Strata Oncology is on its way toward analyzing tumor profiles of more than 10,000 patients this year in an effort to streamline testing and enrollment into clinical trials for targeted therapies.
The company announced a goal in 2016 of profiling 100,000 cancer patients by the end of 2020 and has developed a unique business model for accomplishing that goal. It forges partnerships with healthcare systems and offers free testing to advanced cancer patients, then charges pharmaceutical companies for access to that data, which they can use to identify patients suitable for enrollment into their clinical trials.
Thus far, the Ann Arbor, Michigan-based company has partnered with 10 healthcare systems in the US. Most recently, it partnered with Aurora Healthcare and the University of Texas Health Sciences in March.
The company also has partnerships with Christiana Care's Helen F. Graham Cancer Center and Research Institute in Delaware, Kaiser Permanente-Northern California, Kettering Health Network in Ohio, Metro Minnesota Community Oncology Research Consortium, Ochsner Health System in Louisiana, the University of Alabama-Birmingham Comprehensive Cancer Center, the University of North Carolina Lineberger Comprehensive Cancer Center, and the University of Wisconsin Carbone Cancer Center.
Separately, Strata has also forged a partnership with the University of California, San Francisco specifically for metastatic prostate cancer patients.
Those 10 healthcare systems form Strata's Precision Oncology Network. The network makes up the core of Strata's offerings to pharmaceutical companies and provides clinical research opportunities for investigators at the various partner sites.
By partnering with Strata, pharmaceutical companies gain access to the data generated within that network, which includes de-identified molecular profiling data from NGS testing, as well as other relevant clinical data like treatment history and outcomes.
Last year, Strata announced partnerships with two pharmaceutical companies, Clovis Oncology and Epizyme, to identify patients with specific genetic alterations for the companies' clinical trials.
Strata CEO Dan Rhodes said that the firm's goals in 2018 are to continue to forge new partnerships with pharmaceutical companies, which it expects to do as it generates more patient data, and to scale up its ability to generate tumor profiling data. Currently, he said, the firm is analyzing patients' tumors at an annualized run-rate of 10,000 patients, but its goal is to increase that to 25,000 tests per year and eventually 50,000 per year.
All patients with advanced cancer at its partner healthcare systems are eligible for free profiling via a DNA and RNA 87-gene panel to which Strata recently added microsatellite instability testing. The panel is run using Thermo Fisher Scientific's Ion Torrent sequencing technology and is based in part on the Oncomine Cancer Panel, which is being used in the National Cancer Institute's Match trial.
Rhodes said that the firm grew slowly in 2017 as it sought to overcome the challenges associated with integrating NGS testing as a standard within a healthcare system. "Moving testing from an individual physician-patient encounter to something a health system does as a standard had a whole number of challenges," Rhodes said, including those associated with both pathology and IT and "just setting that practice norm with the treating oncologist," he said.
Now though, Rhodes said, Strata has a streamlined, formal protocol with IRB oversight. Strata returns a report to the physician with results that are integrated into the patients' electronic medical records. The report also highlights available clinical trials.
"The model is working," Rhodes said. "Now it's all about scale and getting to that critical mass."
Strata not only provides the physicians and health systems with the results of the individual patient's molecular test, but also enables the network's members to access the full de-identified dataset. That "creates research opportunities locally, and now that we're reaching a critical mass investigators are contemplating studies that leverage the whole network," Rhodes said.
Rhodes declined to provide exact numbers of patients tested and patients for whom the test revealed a targeted therapy or clinical trial, but said dozens of patients have enrolled in the pharma partners' clinical trials. More than 10 percent of patients tested match to an available trial, Rhodes said.
He said the firm plans to present an abstract at the American Society of Clinical Oncology meeting in June describing the first several thousand patients screened and their outcomes.
On the pharma side, Strata provides partners with access to the de-identified data and facilitates patient recruitment into clinical trials. Having health system-wide NGS testing is key for clinical trial recruitment, Rhodes said, since that gives the pharma companies "access to a large population of pre-screened patients that are concentrated across the healthcare partners." In some sense, Rhodes said, Strata's role is similar to that of a CRO, but it goes beyond clinical trial recruitment in that it also does the molecular testing. "I don't think any company has looked at the problem the way we have and devised a fully functional network of sites with prescreened patient populations," he said.
However, he acknowledged that in order to be attractive for pharmaceutical companies, large numbers of patients are required. "Other testing companies are ahead of us in terms of the numbers of patients profiled, but because the physicians just ordered a test and aren't enrolled in a system-wide screening protocol" it's not as easy to enroll those patients into clinical trials.
From a competition standpoint, Strata has a different business model than companies like Foundation Medicine, which markets an NGS-based tumor profiling assay. Physicians order and pay for the Foundation test and have access to a portal where they can identify and connect with oncologists who have treated patients with similar molecular profiles. Strata, by contrast, does the molecular profiling for free. But, it does so, not in a one-off situation but system-wide. Rhodes said it is most similar to large academic cancer centers, like Memorial Sloan Kettering or MD Anderson Cancer Center, which both have system-wide tumor profiling programs.
Those centers "have major efforts similar to what we're doing," he said, "so they don't have a need for our services." But, he noted, "there's a large segment of the market that desires precision oncology and no one is providing this full-stack solution." Those may be healthcare centers that don't have the ability to implement a patient-wide testing protocol internally.
Rhodes said that the ultimate goal is to have a database with massive amounts of patient data such that pharmaceutical companies can "plan a study based on the patients and genetic profiles available in the database, not a study to which pharma hopes they can accrue patients, but where they know the patients exist and that there's a pathway to enrollment."
Rhodes said that in the future, he would consider making changes, like adding information to the NGS test or offering slightly different partnership models for pharmaceutical companies depending on their needs.