Strata Oncology expands trial of new cancer test

ANN ARBOR—Strata Oncology Inc., developers of novel cancer treatment, 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 StrataMRD 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, CEO and co-founder. “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.”

Patients interested in learning more about the Strata Sentinel trial can visit 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.

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