FDA approves Guardant360 CDx to detect lung cancer gene mutations

Aug. 30, 2021

The U.S. Food and Drug Administration (FDA) approved an additional indication for the Guardant360 CDx, a laboratory test designed to detect gene mutations found in circulating cell-free DNA (cfDNA).

The test is used to help doctors identify patients with non-small cell lung cancer (NSCLC) who may benefit from specific FDA-approved treatments.

This approval expands the indications for use of the Guardant360 CDx test to include an additional mutation (KRAS G12C) as a target for treatment options for NSCLC patients. For patients with the KRAS G12C genetic mutation, this test may help identify if treatment with the drug LUMAKRAS (sotorasib) will be appropriate.

Guardant360 CDx test helps select eligible NSCLC patients carrying KRAS G12C mutations for treatment with LUMAKRAS (sotorasib) as demonstated during clinical study. The test also provides information to the doctor about mutations in 55 genes that could be associated with the patient’s tumor, which can help plan personalized treatment.

Visit the FDA for more news