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Oncocyte, Italian Foundation to Investigate DetermaIO in Colorectal Cancer

NEW YORK – Oncocyte said Thursday that it has entered into a strategic collaboration with Gruppo Oncologico del Nord-Ovest, or GONO Foundation, of Pisa, Italy, to evaluate the company's immunotherapy response predictor DetermaIO in metastatic colorectal cancer.

DetermaIO measures the expression of genes that are thought to play a role in the interaction between a tumor and its immediate microenvironment. According to Oncocyte, this is the fifth tumor type in which its tissue-based assay is being evaluated, with previous efforts focused on lung, breast, bladder, and renal cancers.

Chiara Cremolini, president of the GONO Foundation and assistant professor at the University Hospital of Pisa, cited the growing body of data for DetermaIO in other cancer indications as a driver for its decision to evaluate the assay in CRC.

"Determining which metastatic colorectal cancer patients not bearing microsatellite instability who are currently excluded from immune therapy, but who may benefit from this treatment option, will be a very important milestone in treatment of this devastating disease," she said in a statement.

Cancer immunotherapies are already approved for CRC patients whose tumors show microsatellite instability, or MSI, but these individuals make up only about 10 percent of the overall metastatic colorectal cancer population. This has driven efforts to identify and validate novel biomarkers that could capture additional responders who are MSI-negative.

Oncocyte CSO Doug Ross said the firm views the new collaboration as a step forward in investigating the possibility of pan-cancer applicability for DetermaIO.

"If [we] can successfully identify additional patients who would respond to IO therapy but are not indicated by the MSI marker, this would become another significant step," added Heinz-Josef Lenz, a member of Oncocyte's medical advisory board and USC oncologist.

Financial terms of the agreement with GONO Foundation were not disclosed.