FDA Approves Guardant360 CDx Companion Diagnostic For ESR1-Mutated Breast Cancer

Guardant Health reported that its Guardant Reveal test detected 81% of distant melanoma recurrences in a multicenter study, with 100% specificity. The test also identified ctDNA signals 70.5 days before clinical detection, according to the company.

Grail's Galleri test, which screens for 50 cancers, is under FDA review for approval. A major study failed to prove it detects later-stage cancers, causing skepticism among doctors. Grail's stock dropped 50% on the news but has since rebounded. FDA approval could lead to insurance coverage and impact competitors like Caris Life Sciences and Guardant Health.

Guardant Health (GH) received FDA approval for its Guardant360 CDx liquid biopsy as a companion diagnostic for advanced HR-positive, HER2-negative breast cancer. This is the first FDA-approved liquid biopsy for longitudinal ctDNA testing in breast cancer. The approval was supported by clinical trial data showing early detection of ESR1 mutations. The company focuses on precision oncology, using blood and tissue tests to tailor cancer treatments. Investors should monitor the impact on future reve

Guardant Health (GH) received FDA approval for Guardant360 CDx, a liquid biopsy test to monitor ctDNA in advanced breast cancer. The test guides treatment decisions before disease progression, targeting about 37,000 eligible patients in the US. This approval may influence oncologist testing habits, payer coverage, and Guardant's competitive position in cancer diagnostics.

Guardant Health (GH) was ordered to pay $245.2M for patent infringement, with a 6% royalty on US sales of 11 products until 2033. The company plans to appeal, noting current versions of Reveal and Shield are excluded. The judgment includes $83.4M in damages, $19.5M in supplemental damages, $119.4M in royalties, and $22.9M in interest.

Guardant Health (GH) received FDA approval for Guardant360 CDx as a companion diagnostic for AstraZeneca's ETCAMAH in advanced breast cancer. The approval, based on the SERENA-6 trial, showed a 56% reduction in disease progression risk when using ctDNA-guided treatment. The test is recommended for use every three months during therapy.