Study will evaluate performance of tumor-informed ctDNA-based minimal residual disease (MRD) testing and clinical benefit of therapy in ctDNA-positive patients

Strata Oncology, Inc., a precision oncology company advancing new molecular indications for cancer therapies, today announced enrollment of the first patient in the Strata Sentinel^TM trial, a prospective, observational study that will evaluate the ability of the investigational StrataMRD^TM 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 ctDNA-positive after surgery or other therapy with curative intent.

“We see an incredible opportunity to bring the precision oncology advances we’ve seen in late-stage cancer to patients with early-stage disease,” said Dan Rhodes, Ph.D., co-founder and Chief Executive Officer, Strata Oncology. “The hope for early-stage cancer patients is that their disease will be cured with their initial treatment, but we know many will have a recurrence. By characterizing patients’ tumors and then monitoring for MRD via a highly sensitive and specific liquid biopsy test, we can help their doctors make informed decisions as soon as possible about whether to put them on therapy, and whether a biomarker-matched targeted therapy, immunotherapy or antibody-drug conjugate may be optimal.”

StrataMRD is a tumor-informed, personalized ctDNA test to detect tumor recurrence and monitor treatment effectiveness. If a patient is found to be ctDNA-positive during the course of regular monitoring, a comprehensive therapy selection profile derived from the same tumor tissue sample used to develop the personalized test can help guide treatment decisions.

“We are pleased to be a part of the Strata Sentinel trial.  Bringing the latest innovations in precision oncology to our patients is critical to our vision of changing and saving lives,” said Marc Matrana, MD, Director, Precision Cancer Therapies Research Program, Endowed Professor of Experimental Therapeutics, and Associate Director of Clinical Cancer Research, Ochsner Cancer Institute, the site at which the first Sentinel patient has been enrolled. “We look forward to working with Strata Oncology to change the paradigm of care for patients with early-stage cancer.”

A key feature of StrataMRD is its 0.01% tumor content limit of detection, which is made possible by Strata’s personalized approach of exhaustively searching the blood for specific mutations known to occur in each patient’s tumor.

“In the future we’ll know very soon after initial treatment which early-stage cancer patients are or are not destined for recurrence,” said Rhodes. “With that information, we can get patients who need their optimal precision therapy long before a full-on recurrence of metastatic disease, and we can spare those patients who really are cured from the toxicities and costs of unnecessary adjuvant treatment.”

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 PATHTM 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.

About MRD
The treatment plan for patients with early-stage cancer often entails surgery, chemotherapy or radiation (or some combination of these) given with the intent of curing the disease. However, very small numbers of cancer cells that are undetectable using standard techniques like imaging may remain in the body. These remaining cells are called minimal residual disease (MRD) and often result in recurrence. MRD can be detected using circulating tumor DNA (ctDNA), which consists of small pieces of tumor-derived DNA that are shed into the bloodstream. Cancer that remains at low levels after initial treatment is also called micrometastatic.

About StrataMRD
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 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.