Amgen will work with diagnostic companies Guardant Health and Qiagen to develop blood- and tissue-based companion diagnostics (CDx) for investigation cancer treatment AMG 510 – the first KRASG12C inhibitor to advance to the clinical for investigation in treating multiple tumour types.
KRAS G12C is one of the most frequently mutated oncogenes in human cancers. The agreements with both companies will initially focus on CDx tests for non-small cell lung cancer (NSCLC) but allow for further development of the diagnostic tests for Amgen’s other oncology clinical development programs.
“Collaborating with Qiagen and Guardant Health to have both tissue- and blood-based diagnostic tests available will help to identify patients with NSCLC who may benefit from AMG 510,” said David M. Reese, Executive Vice President of R&D at Amgen.
Amgen will work with Qiagen to develop a tissue-based diagnostic test utilising its therascreen platform to identify patients whose cancers have the KRAS G12C mutation.
Qiagen will also pursue global regulatory approvals, including Pre-Market Approval (PMA) from the FDA.
To enable biomarker testing in patients for whom insufficient tissue remains a challenge, Amgen is also collaborating with Guardant Health to develop a liquid biopsy CDx.
Guardant360 CDx is a multi-tumour comprehensive NGS (Next Generation Sequencing) test that is being developed to identify patients with actionable alterations, in this instance with the KRAS G12C mutation in NSCLC.
Guardant Health will seek global regulatory approvals for the test, including a PMA from the FDA.