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Oncocyte, Fondazione Michelangelo to Evaluate DetermaIO Test for Immunotherapy Response Prediction

NEW YORK – Oncocyte said on Thursday that it is collaborating with the Fondazione Michelangelo in Milan, Italy to evaluate the company's DetermaIO test as a therapy response predictor in the NeoTRIPaPDL1 trial.

DetermaIO is a tissue-based gene expression assay, designed to evaluate signals associated with the tumor immune microenvironment. The test stratifies patients according to their likelihood of responding to immunotherapy.

Investigators from the Italian institution are conducting a prospectively designed, retrospective study of archived material from the NeoTRIPaPDL1 trial, which is evaluating the addition of atezolizumab (marketed by Genentech as Tecentriq) to chemotherapy in patients with early high-risk and locally advanced triple negative breast cancer compared to chemotherapy alone. Investigators said that the decision to use DetermaIO in their biomarker analysis is based on earlier research showing the assay could identify patients with both TNBC and other cancer types who respond to immunotherapy.

In particular, Oncocyte highlighted data presented at recent scientific conferences, where researchers from the West Clinic and MD Anderson Cancer Center presented results showing the test outperformed the two currently available biomarkers, PD-L1 and tumor mutational burden, in cohorts of TNBC and non-small cell lung cancer patients.

Luca Gianni president of Fondazione Michelangelo said in a statement that the prior data is "very promising and suggest that DetermaIO may enable the identification and selection of TNBC patients who are most likely to benefit from checkpoint inhibitors."

"We are very hopeful that DetermaIO's ability to comprehensively assess the tumor microenvironment will improve patient stratification and, ultimately, contribute to better tailored administration of immune-checkpoint therapy," he added.

Oncocyte CEO Ron Andrews said that the partnership adds to a growing list of efforts it hopes can lay the groundwork for expanding the use and adoption of DetermaIO. According to Andrews, building evidence for use of the assay in selecting patients for immunotherapy is something the company believes could be a significant revenue growth engine, assuming a potential $3 billion testing market for immunotherapy patient selection.