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Guardant Health, AnHeart Tx to Develop Blood- and Tissue-Based CDx for NSCLC Drug

NEW YORK – Guardant Health and AnHeart Therapeutics on Thursday announced a strategic collaboration to develop and commercialize the Guardant360 CDx and Guardant360 TissueNext assays as companion diagnostics for the use of taletrectinib in adults with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in the US and Europe.

The US Food and Drug Administration granted taletrectinib breakthrough therapy designation last year for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 tyrosine kinase inhibitor treatment naïve or were previously treated with crizotinib.

Financial details of the collaboration were not disclosed.

Last year, Guardant360 CDx received FDA premarket approval as a companion diagnostic to Enhertu (trastuzumab deruxtecan), also for NSCLC. The blood-based liquid biopsy covers genomic alterations in circulating tumor DNA across 55 genes.

"Our tissue- and blood-based assays play an essential role in the diagnosis of cancers by revealing actionable mutations that can help oncologists quickly match patients to the right targeted treatment," Helmy Eltoukhy, Guardant Health's co-CEO, said in a statement.

Guardant360 TissueNext identifies patients with advanced cancer who may benefit from biomarker-informed treatment. 

It received Medicare coverage last year and was recently licensed to Codex Genetics for distribution in Hong Kong and Macau.