FDA Approves Larger Guardant360 Liquid CDx
Shares of the liquid biopsy company are up 20 percent since news of the approval broke.
Guardant Health has received FDA approval for Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test that assesses a wider genomic footprint than the company’s previously approved Guardant360 CDx.
The Palo Alto, California-based company said on May 20 that the new test integrates genomic and epigenomic profiling from a single blood draw, providing increased sensitivity for circulating tumor DNA (ctDNA) detection compared with the prior test. The seven companion diagnostic indications previously approved for Guardant360 CDx transfer to the new test under the approval.
The test is “the largest FDA-approved liquid biopsy panel and covers a 100-fold larger genomic footprint versus the prior tissue-based G360 CDx,” Canaccord Genuity Analyst KYle Mikson wrote in a May 20 note to investors. “The approval also expands future companion diagnostic opportunities, which could drive higher-margin biopharma revenue and support broader adoption of [Guardant’s Reveal circulating tumor DNA monitoring tests] as a complementary monitoring assay. More broadly, the approval advances Guardant’s Smart Platform and multiomic strategy, while potentially supporting […] portfolio simplification.”
Since the close of the market on May 19, shares of Guardant are up 20 percent at $118.01.
Guardant360 Liquid CDx is intended to support treatment selection decisions for patients with advanced cancer. The test is already approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer, and is the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations, according to Guardant.
Guardant noted that its Smart Platform, a multiomic technology platform that the company said integrates genomic and epigenomic data, now underlies its full product portfolio.
“Guardant can now apply for [Medicare’s] Advanced Diagnostic Laboratory Test status for Guardant360 Liquid CDx, which comes with favorable pricing opportunities,” Guggenheim Securities Analyst Subbu Nambi added in a note to investors. “Based on management’s commentary, this is what we would expect them to pursue next.” Guardant could also sell the blood-based and tissue-based tests together as well as streamline ordering for blood-based tests, she said.