Illumina and Kartos Therapeutics have partnered to co-develop a next-generation sequencing-based TP53 companion diagnostic (CDx) for various hematologic indications.

The CDx will be based on Illumina’s genomic profiling assay, TruSight Oncology 500 (TSO 500), and be the first CDx to make use of TSO 500 with peripheral whole blood as the diagnostic sample type.

A research-use only pan-cancer assay, the TSO 500 system is designed for the detection of 523 known and emerging tumour biomarkers.

It uses both DNA and RNA from tumour samples to distinguish key variants, including small DNA variants, fusions and splice variants, which are essential to the development and progression of cancer.

Illumina chief medical officer Phil Febbo said: “With this partnership, Illumina will expand the TruSight Oncology offerings into hematologic malignancies.

“By leveraging our technology and harnessing the expertise at Kartos, we continue to advance Illumina’s commitment to develop standardised, globally distributable tools for precision oncology.”

The partnership will initially focus on co-developing various CDx claims in blood cancers for Kartos’ KRT-232, a selective oral MDM2 inhibitor that triggers p53 and therefore causes the death of tumour cells in TP53 wild-type cancers.

KRT-232 is presently in the clinical development stage for various TP53 wild-type haematological malignancies and solid tumours.

Kartos chief medical officer and CEO Jesse McGreivy said: “Kartos is dedicated to developing novel, targeted therapeutics that meaningfully improve the lives of patients with cancer.

“This partnership will allow us to capitalise 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 tumour suppressor proteins, resulting in apoptosis of malignant cells across a variety of hematologic and solid tumour types.”