AstraZeneca has formed a collaboration with the gene-sequencing company, Illumina, Inc., to develop its next generation sequencing (NGS) platform for companion diagnostic tests applicable across AstraZeneca's oncology portfolio. AstraZeneca intends to apply Illumina's technology to a novel companion diagnostic test in pivotal studies for one of its investigational oncology compounds.

Illumina's NGS technology allows rapid sequencing of multiple genes in a much faster and cheaper way than traditional DNA sequencing methods, according to information from AstraZeneca. Under the collaboration, it will be used to screen a panel of several gene sequences, scanning for all possible genetic variants—known and unknown—rather than specified mutations from a single tumor sample. The information obtained from sequencing full genes will be used to predict which patients will respond to certain treatments and will go through appropriate regulation.

The pact with Illumina is the third diagnostic collaboration formed by AstraZeneca this year. It had earlier announced separate agreements with Roche and Qiagen to develop tests that analyze the DNA from lung cancer patients' tumors circulating in their blood to determine their epidermal growth factor receptor (EGFR) mutation status.

Illumina has also formed strategic partnerships with Janssen Biotech Inc. and Sanofi to develop NGS-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners' clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for companion therapeutics.

See related story, “AstraZeneca Forms Pacts with Roche, Qiagen for Companion Diagnostics”

Source: AstraZeneca and Ilumina