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SWOG to Use Oncocyte's DetermaIO Test in Cancer Biomarker Study

NEW YORK – Oncocyte announced today that the Southwest Oncology Group (SWOG) Cancer Research Network has selected its DetermaIO tumor microenvironment gene expression test for use in a prospective biomarker study of breast cancer tissues.

DetermaIO will serve as a defined secondary endpoint in the ongoing Phase III S1418 clinical trial. If successful, the study will support DetermaIO's use in identifying those patients who received standard preoperative chemotherapy and would likely benefit from one year of treatment with Merck's Keytruda (pembrolizumab) after surgery.

The tissues to be analyzed using DetermaIO were collected in primary triple negative breast cancer (TNBC) from individuals who had been treated with standard-of-care preoperative chemotherapy and still had residual cancer that could be detected after chemotherapy at the time of breast surgery.

Trial participants with cancer that measured over 1 cm and/or had positive lymph nodes were randomized for observation or one year of treatment with Keytruda.

The S1418 trial is being conducted by SWOG and sponsored by the National Cancer Institute through its Cancer Therapy Evaluation Program. SWOG selected DetermaIO as part of a grant proposal to the NCI's Biomarker, Imaging, and Quality of Life Studies Funding Program. Qualifying assays needed to be technically and clinically validated, and therefore ready for clinical use.

"Over their 66-year history, SWOG clinical trials have changed the standards of cancer care by providing unbiased, well-powered clinical studies to validate prescriptive outcomes that inform patient management guidelines," Rob Seitz, head of immune oncology at Oncocyte, said in a statement. "To be partnered with SWOG, in a prospectively designed biomarker study in a large, randomized clinical trial, marks a major milestone for DetermaIO."

Earlier this year, Oncocyte entered into a codevelopment and comarketing deal with Thermo Fisher, facilitating Oncocyte's entry into global markets. As part of the partnership, Oncocyte began developing an IVD version of DetermaIO compatible with Thermo Fisher's Genexus chip.