Guardant360 CDx test is already approved by FDA to guide treatment in all solid tumors, including NSCLC


Guardant Health and Daiichi Sankyo have collaborated to develop Guardant360 CDx as companion diagnostic for Enhertu. (Credit: Belova59 from Pixabay)

Guardant Health has entered into a collaboration with Daiichi Sankyo to develop Guardant360 CDx as a companion diagnostic for Enhertu in advanced metastatic non-small cell lung cancer (NSCLC).

The companies will work together to get regulatory approval and commercialise Guardant360 CDx blood test as a companion diagnostic for Enhertu.

Enhertu is a HER2-directed antibody-drug conjugate (ADC), which is being evaluated for the treatment of patients with advanced metastatic NSCLC.

The Guardant360 CDx test is already approved by the US Food and Drug Administration (FDA) to offer comprehensive genomic profiling results to guide treatment in all solid tumours, including NSCLC.

Guardant Health CEO Helmy Eltoukhy said: “For patients with metastatic non-small cell lung cancer, personalized medicines targeting actionable mutations, as revealed by our Guardant360 liquid biopsy test, have been life-changing.

“Such medicines may extend overall survival for many patients, and we are excited to work with Daiichi Sankyo, as there remains an unmet medical need to help non-small cell lung cancer patients with HER2 mutations.”

In January this year, Guardant Health collaborated with Vall d’Hebron Institute of Oncology (VHIO) to offer first Guardant-based biopsy testing service in Spain.

The company has commercially introduced liquid biopsy-based Guardant360, Guardant360 CDx and GuardantOMNI tests for advanced stage cancer patients. It also offers Guardant Reveal test for early-stage cancer patients.

The tests are said to support Guardant Health’s LUNAR screening programme, which enables to meet the requirements of asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.