100,000-patient prospective, observational study to evaluate ctDNA-based minimal residual disease (MRD) testing
ANN ARBOR, Mich., June 23, 2022 /PRNewswire/ -- Strata Oncology, Inc., a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced that Lehigh Valley Topper Cancer Institute and the University of Michigan Health Rogel Cancer Center have joined as clinical trial sites in the Strata Sentinel™ trial, a prospective, observational study of the StrataMRDTM minimal residual disease test that has the potential to shift the paradigm of cancer care, bringing the use of biomarker-matched precision therapies to earlier stages of the disease.
"The Strata Sentinel trial is a key piece of our strategy of developing integrated solutions to enable smarter and earlier cancer treatment," said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. "We are grateful to add Lehigh Valley Topper Cancer Institute and the University of Michigan Health Rogel Cancer Center to our growing list of partners that we are working with to not only collect clinical validation and utility data, but also to learn together to create the sustainable, scalable systems necessary to deliver the best possible treatment to every patient with cancer."
"At Lehigh Valley Topper Cancer Institute, we are continuously working to improve cancer care, including partnering with innovators to bring the latest technology to the patients we serve," said Suresh Nair, MD, Physician in Chief of the Lehigh Valley Topper Cancer Institute. "With the Strata Sentinel trial, we aim to demonstrate the utility of detecting recurrence as soon as possible using the ctDNA-based StrataMRD test. We will also evaluate the clinical benefit of treating patients with micrometastatic disease, including with biomarker-matched therapies chosen based on the extended treatment selection data provided by Strata Oncology platform."
"By helping identify cancer recurrences as early as possible, StrataMRD has tremendous potential to change how we care for patients after initial cancer treatment," said Todd Morgan, MD, the Jack Lapides, MD, Research Professor at the University of Michigan Medical School and the Chief of Urologic Oncology at University of Michigan Health. "We are pleased to partner with Strata Oncology to not only study the impact of StrataMRD on our patient population, but to work together to establish the workflows and data management systems necessary to implement precision oncology across a health system at scale."
Patients interested in learning more about the Strata Sentinel trial can visit ClinicalTrials.gov and search for the trial identifier: NCT05082701
The Strata Sentinel trial will evaluate the ability of the investigational StrataMRD test to detect cancer recurrence in advance of standard of care techniques across solid tumors, as well as the clinical benefit of treatment in early-stage patients who are or become circulating tumor DNA (ctDNA)-positive after surgery or therapy with curative intent. The Strata Sentinel trial will enroll approximately 100,000 patients with stage 1-3 solid tumors across 25 sites and is the largest trial of its kind to date. Information and samples from participants will be collected during standard of care visits with their doctors. Blood samples will be collected every 3 months and tested for the presence of ctDNA. If recurrence is detected, treating physicians may then use the comprehensive therapy selection profile information to guide treatment decisions, including enrollment in the Strata PATH™ clinical trial. All molecular profiling in the Strata Sentinel trial will be performed at Strata Oncology's Ann Arbor, MI CAP-accredited and CLIA-certified laboratory and outcomes data will be collected for up to five years.
StrataMRD is a tumor-informed, personalized circulating tumor DNA (ctDNA) test to detect tumor recurrence and monitor treatment effectiveness for patients. The investigational test is available through the Strata Sentinel trial. The ultra-sensitive, individualized blood test leverages multiplexed PCR amplicon-based NGS of blood-based ctDNA to monitor for a personalized set of informative mutations. StrataMRD is performed at the Strata Oncology Ann Arbor, MI CAP-accredited and CLIA-certified laboratory.
Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and large-scale clinical trials to identify and deliver optimal treatments for patients with cancer. For more information visit strataoncology.com.
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SOURCE Strata Oncology, Inc.