Boehringer Ingelheim’s Hernexeos has nabbed a companion diagnostic from Guardant Health after the FDA cleared its liquid biopsy test, Guardant360 CDx.
Hernexeos was approved last August for previously treated non-small cell lung cancer (NSCLC) patients who have relatively rare HER2 activating mutations in the tyrosine kinase domain.
The mutated cancer type occurs in around 2% to 4% of NSCLC cases and affects around 40,000 patients globally. Hernexeos became the first FDA-approved oral treatment that can specifically target the disease.
Now, Guardant Health can help find those patients. Its test probes circulating tumor DNA from a blood draw to seek out HER2 tyrosine kinase domain activating mutations.
This latest FDA approval for Guardant360 CDx marks the 27th companion diagnostic indication across multiple cancers around the world.
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“This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time,” said Helmy Eltoukhy, Ph.D., Guardant Health chairman and co-CEO, in a statement.
“Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy.”
