UK-based AstraZeneca has signed an agreement with US-based Foundation Medicine to develop a new diagnostic assay for Lynparza (olaparib).
Lynparza is an orally administered poly ADP-ribose polymerase (PARP) inhibitor that leverages on tumour DNA repair pathway deficiencies to eliminate cancer cells.
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Under the deal, Foundation Medicine will develop a regulatory approved product based on its quality systems regulations (QSR) compliant version of FoundationOne comprehensive genomic profiling platform.
A multiple class of genomic alterations across a range of genes involved in homologous recombination repair (HRR) will be detected by the new assay, which is based on a scientifically selected panel of genes involved in driving the HRR process.
AstraZeneca Lynparza global medicine lead Nina Mojas said: "This agreement supports the broad development programme for our first-in-class PARP inhibitor, Lynparza.
"Utilising Foundation Medicine’s leading capabilities in molecular information will help our work to assess the potential of the medicine to address unmet patient need across a number of cancers driven by DNA repair deficiencies, including and significantly beyond the BRCA mutations."
The assay will be developed in conjunction with the clinical programme for Lynparza, as a part of a coordinated drug-diagnostic regulatory strategy.
The companion diagnostic assay will assist physicians to determine the specific patients who will be benefitted from AstraZeneca’s PARP inhibitor, Lynparza.
