NEW YORK – Guardant Health said Wednesday that it has entered into a collaboration with Boehringer Ingelheim to pursue regulatory approval and commercialization of its Guardant360 CDx liquid biopsy assay as a companion diagnostic for Boehringer's investigational drug zongertinib in lung cancer.
Under the deal, the companies intend to pursue a new CDx indication for Guardant's blood-based comprehensive genomic profiling test to identify lung cancer patients with HER2 mutations who may be eligible for treatment with Boehringer’s new drug once it gains US Food and Drug Administration approval.
Zongertinib is a covalent tyrosine kinase inhibitor that selectively inhibits HER2 while sparing EGFR.
Guardant360 CDx is already FDA approved as a companion diagnostic for drugs targeting alterations in EGFR, HER2, KRAS, and ESR1.