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Illumina, Kartos Therapeutics Partner to Develop TP53 Companion Diagnostic

NEW YORK – Illumina and Kartos Therapeutics announced a partnership on Thursday to develop a next generation sequencing-based TP53 companion diagnostic.

The diagnostic will be based on Illumina's pan-cancer comprehensive genomic profiling assay, TruSight Oncology 500, or TSO 500, and will be used to detect TP53 mutations in multiple hematologic indications. The partnership will initially focus on developing a companion diagnostic for Kartos's MDM2 inhibitor, KRT-232.

Kartos has several ongoing clinical trials for KRT-232 in TP53 wild-type blood cancers, including acute myeloid leukemia, myelofibrosis, polycythemia vera, chronic myelogenous leukemia, and B-cell malignancies.

"Kartos is dedicated to developing novel, targeted therapeutics that meaningfully improve the lives of patients with cancer," Jesse McGreivy, Kartos' CEO and CMO, said in a statement. "This partnership will allow us to capitalize on TSO 500 as we explore the expanded use of KRT-232, which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells across a variety of hematologic and solid tumor types."

Redwood City, California-based Kartos is also studying KRT-232 in some solid tumors with TP53 mutations, such as glioblastoma, soft tissue sarcoma, and Merkel cell carcinoma.

Illumina's TSO 500 is currently used only for research and can identify 523 known and emerging tumor biomarkers. The new diagnostic will be the first to use TSO 500 with peripheral whole blood as a sample type.

This year, Illumina has also inked companion diagnostic partnerships with Bristol Myers Squibb, Kura Oncology, Merck, Myriad Genetics, and Qiagen.