FDA okays Guardant360 as companion diagnostic in patients with ESR1 mutations

Guardant Health announced that the U.S. Food and Drug Administration FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU, elacestrant , a nonsteroidal selective estrogen receptor degrader to be commercialized by Stemline Therapeutics , a wholly-owned subsidiary of Menarini Group. "This FDA approval is great news for breast cancer patients with ESR1 mutations, who now have, for the first time, an approved treatment for their specific type of cancer and a blood-based companion diagnostic," said Helmy Eltoukhy, Guardant Health co-CEO. "We are pleased that the Guardant360 CDx liquid biopsy is now approved so that oncologists and their patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy." "We are proud to bring the very first treatment targeting ESR1 mutations which are present in up to 40% of ER+/HER2- advanced breast cancers," commented Elcin Barker Ergun, CEO of Menarini Group. "We’re also pleased with the approval of the Guardant360 CDx blood test as the companion diagnostic to help oncologists identify patients who may benefit from this innovative endocrine therapy."