Guardant Health, Inc. (Nasdaq: GH), announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic (CDx) test for Amgen’s AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. Under the agreement, Guardant Health will pursue U.S. Food and Drug Administration (FDA) Pre-Market Approval, Japan Pharmaceutical and Medical Device Agency Approval, and European CE-Mark for Guardant360® CDx as a companion diagnostic for AMG 510 in metastatic non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation.

AMG 510 is the first-in-class KRAS G12C inhibitor to advance to the clinic, and Amgen is currently enrolling patients in a potentially registrational Phase 2 study. AMG 510 is designed to selectively and irreversibly target a specific mutant form of KRAS called G12C that is present in nearly 13 percent of all NSCLC patients1 and for whom limited targeted treatment options have existed to date. The FDA granted Orphan Drug Designation to AMG 510 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.

“In a recent head-to-head study of liquid versus tissue testing,2 Guardant demonstrated that advanced non-small cell lung cancer patients are not consistently receiving adequate genotyping results from tissue,” said AmirAli Talasaz, PhD, Guardant Health President. “We believe that the development of Guardant360 CDx will lead to consistently delivered guideline-complete genotyping results along with other important genomic information to patients and their providers through blood, which will ultimately increase the number of patients who are identified as eligible for targeted therapies, including AMG 510, and thus improve access to these potentially life-changing treatments.”

“The potential of AMG 510 to specifically target KRAS G12C, a mutation that was once thought to be undruggable, represents a major therapeutic advancement in advanced non-small cell lung cancer,” said Sanket Agrawal, general manager of the KRAS program at Amgen. “Amgen is committed to driving broad accessibility to biomarker testing. Collaborating with Guardant Health to develop their Guardant360 blood test as a companion diagnostic will help ensure that all eligible non-small cell lung cancer patients receive biomarker testing.”