This study demonstrates the analytical and clinical validity of the approved (United States and Japan) plasma-based Guardant360 companion diagnostic (CDx) test for selecting patients with human epider...

After weighing experts' concerns, the agency is requiring AstraZeneca to conduct a confirmatory trial comparing switching to Etcamah at molecular progression against switching at radiographic progression.

The approval adds an additional indication for Inluriyo in ESR1-mutant breast cancer, where it was previously approved as a monotherapy.

What Guardant Health, Inc. changed in their own words, quarter over quarter.

Guardant Health (GH) received FDA approval for its Guardant360® CDx as a companion diagnostic to identify ESR1 mutations in HR-positive, HER2-negative advanced or metastatic breast cancer patients who may benefit from AstraZeneca’s ETCAMAH™ (camizestrant) before radiographic progression.The approval recommends repeat Guardant360 CDx liquid biopsy testing every three months during therapy for longitudinal ctDNA surveillance. In the Phase III SERENA-6 trial, patients who switched to ETCAMAH plus a CDK4/6 inhibitor after ESR1 mutation detection saw a 56% reduction in risk of disease progression or death and 74% longer median progression-free survival (16.0 vs. 9.2 months), along with a 47% reduction in risk of deterioration in global health status and quality of life.This marks the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer and the 29th CDx indication for Guardant360 CDx across multiple tumor types, supported by broad reimbursement coverage representing more than 300 million covered lives. The company estimates approximately 37,000 women in the U.S. could potentially benefit from this new therapeutic approach.

At least 500 Guardant360 Liquid CDx assays will be made freely available to cancer patients as a proof of concept for a wider precision medicine initiative.

The investment bank said that it expects rising Guardant360 Liquid CDx prices to drive revenue growth of approximately 45 percent over the next two years.

Treatment selection guided by the Guardant360 CDx comprehensive genomic profiling assay led to improved patient outcomes in a Phase 3 clinical trial.

The company's Guardant360 CDx received approval for identifying ESR1 mutations in breast cancer patients to assess their eligibility for treatment with Lilly's Inluriyo.

It's the sixth companion diagnostic approval for the Guardant360 comprehensive genomic profiling assay, which is intended to support personalized cancer treatment.