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Amgen collaborating with Qiagen, Guardant on companion tests for cancer therapy

Amgen Inc. is collaborating with Qiagen NV and Guardant Health Inc. to develop blood- and tissue-based companion diagnostics for Amgen's experimental cancer treatment.

Thousand Oaks, Calif.-based Amgen's AMG 510 is an oral therapy that inhibits the KRAS G12C mutant protein.

A KRAS inhibitor is a type of drug that targets a mutation in a group of proteins called RAS that make proteins involved in cell signaling pathways that control cell growth and cell death. Mutations to these signal proteins appear in about a third of all human cancers and have been studied for more than 30 years as a possible but difficult lever to pull in treating these cancers.

Amgen said the agreements with both companies will initially focus on tests for non-small cell lung cancer, or NSCLC, but will allow for further development of the tests for Amgen's other oncology clinical development programs.

Qiagen's therascreen platform will be used to identify patients with the KRAS G12C mutation. Netherlands-based Qiagen will be responsible for global regulatory approvals, including pre-market approval from the U.S. Food and Drug Administration.

Amgen is collaborating with Guardant Health to develop a liquid biopsy companion diagnostic using the Redwood City, Calif.-based company's Guardant360 to identify patients with actionable alterations, in this instance with the KRAS G12C mutation in NSCLC. Guardant will pursue global regulatory approvals for the test, including a premarket approval from the FDA.

Financial details of the agreements were not disclosed by the companies.

Amgen is enrolling patients for a phase 2 study of AMG 510, which helped shrink tumors in lung cancer patients in an early-stage trial.

AMG 510, which is also being developed for patients with colorectal cancer, has been granted the FDA's orphan drug designation for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation and fast-track designation for previously treated metastatic NSCLC with KRAS G12C mutation.