The US Food and Drug Administration has approved Guardant360 Liquid CDx, a blood-based comprehensive molecular profiling assay from Guardant Health designed to support treatment selection in patients with advanced cancer, according to a company press release. The updated assay expands on the previously approved Guardant360 CDx and retains its seven FDA-approved companion diagnostic indications.

Guardant Health stated that the assay is the largest FDA-approved liquid biopsy panel, with a genomic footprint 100 times broader than the prior version. The test combines genomic and epigenomic profiling from a single blood draw to provide comprehensive tumor profiling and improve circulating tumor DNA detection sensitivity compared with the earlier assay. According to the company, the platform may identify clinically actionable findings not detected through genomic analysis alone.

The assay is based on the company’s Smart Platform, an artificial intelligence-enabled multiomic platform intended to support molecular testing across blood- and tissue-based applications. Guardant Health stated that the platform incorporates data derived from more than 1 million patients tested and is designed for use across multiple stages of cancer care, including treatment selection, recurrence monitoring, and cancer screening.

“Precision oncology is only as strong as the information clinicians have at the moment they need to make a decision,” stated Guardant Health chairman and co-CEO, Helmy Eltoukhy. "This approval moves us closer to a future where every physician has the right information at the right time to make the right decision." 

The assay received companion diagnostic approval for several therapies used in non–small cell lung cancer and colorectal cancer. The company also stated that the assay is the only FDA-approved liquid biopsy companion diagnostic for targeted therapy selection in patients with advanced breast cancer and ESR1 mutations. According to the press release, the assay is covered by Medicare and commercial insurers representing more than 300 million covered lives. 

Guardant Health reported that the assay can provide results within 7 days and may be used regardless of tissue availability, practice setting, or line of therapy.

Source: Guardant Health