Original from: Guardant Health
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a collaboration with Boehringer Ingelheim to pursue the regulatory approval and commercialization of the Guardant360® CDx liquid biopsy as a companion diagnostic (CDx) for zongertinib, an investigational covalent tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).
As part of the collaboration, the Guardant360 CDx blood test will provide comprehensive genomic profiling (CGP) of tumors to identify actionable biomarkers that allow targeted therapy selection and help identify NSCLC patients with HER2 mutations who may be eligible for treatment with Boehringer¡¯s investigational zongertinib after it is approved by health authorities.
¡°Many of the 40,000 people diagnosed worldwide every year with NSCLC with a HER2 mutation may respond poorly to standard chemotherapy and immunotherapy,¡± said Helmy Eltoukhy, Guardant Health chairman and co-CEO. ¡°This collaboration with Boehringer Ingelheim to pursue approval of the Guardant360 CDx test as a companion diagnostic would allow oncologists, using a simple blood draw, to identify patients with advanced lung cancer who have HER2 mutations targeted by zongertinib and could benefit from this investigational therapy.¡±
The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx is approved as a companion diagnostic for multiple targeted therapies in NSCLC. It is also the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations and has broad commercial and Medicare coverage.
