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Guardant Health to Develop Liquid Biopsy Companion Diagnostic for Janssen NSCLC Therapy

NEW YORK – Guardant Health said today that it has entered a strategic collaboration with Janssen Biotech to pursue regulatory approval and commercialization of its Guardant360 assay as a companion diagnostic for amivantamaban investigational EGFR-MET bispecific antibody that Janssen is advancing for the treatment of non-small cell lung cancer. 

The agreement covers the US, Canada, Japan, and Europe. Financial terms were not disclosed. 

Guardant360 is a blood-based cancer genotyping test, which uses targeted next-generation sequencing to detect alterations in 74 genes. The test is covered by Medicare for use across a range of advanced solid tumors, including metastatic NSCLC. 

In a statement, Guardant Health President AmirAli Talasaz argued that despite the availability of increasing numbers of new targeted drugs, many NSCLC patients are still not comprehensively genotyped before starting therapy. As a result, they risk missing out on opportunities for precision oncology treatment. 

"Guardant360 liquid biopsy has been shown to overcome the barriers associated with tissue, and increase genotyping rates, which we believe will ultimately help ensure that all patients who are eligible for potentially life-changing therapies are identified from the start," Talasaz added.