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Guardant Health and Boehringer Ingelheim Collaborate to Advance Liquid Biopsy CDx for HER2-Targeted Therapy in NSCLC

NextEdge Admin

18 Dec 2024

2 min 16 sec

Boehringer Ingelheim,Liquid Biopsy CDx,NSCLC,HER2

Guardant Health, a leader in precision oncology, announced a collaboration with Boehringer Ingelheim to pursue regulatory approval and commercialization of the Guardant360® CDx liquid biopsy as a companion diagnostic (CDx) for zongertinib. This investigational covalent tyrosine kinase inhibitor (TKI) selectively targets HER2 while sparing EGFR in non-small cell lung cancer (NSCLC).

Through this partnership, the Guardant360 CDx blood test will provide comprehensive genomic profiling (CGP) to identify actionable biomarkers, enabling oncologists to identify NSCLC patients with HER2 mutations who may be candidates for zongertinib after regulatory approval.

“Many of the 40,000 people diagnosed annually with NSCLC harboring HER2 mutations respond poorly to standard treatments,” said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. “This collaboration would enable oncologists to use a simple blood draw to identify patients who could benefit from zongertinib.”

The Guardant360 CDx is the first FDA-approved liquid biopsy for all advanced solid tumors and is already an approved CDx for multiple targeted therapies in NSCLC. It is also the only FDA-approved CDx for identifying patients eligible for breast cancer therapies targeting ESR1 mutations, with extensive commercial and Medicare coverage.

Founded in 2012, Guardant Health is transforming cancer care by delivering critical insights through advanced blood and tissue tests, real-world data, and AI analytics. Guardant’s tests support improved outcomes across the cancer care continuum, including early detection, recurrence monitoring, and treatment selection in advanced disease.