The Food and Drug Administration has approved a liquid biopsy diagnostic test that the manufacture is calling the first such test for comprehensive tumor mutation profiling across solid tumor cancers.
Redwood City, California-based Guardant Health said late Friday afternoon that the FDA had approved its Guardant360 CDx in patients with any solid tumor, as well as approving it as a companion diagnostic to identify patients with non-small cell lung cancer patients with EGFR alterations who may benefit from AstraZeneca’s Tagrisso (osimertinib).
Shares of Guardant rose 5.6% on the Nasdaq toward the end of the day Friday and were trading up 2.8% premarket Monday morning. The company’s shares were subsequently up about 4% when markets opened.
The approval was based on data from more than 5,000 patient samples. Data from two Phase III clinical trials, FLAURA and AURA3, showed that NSCLC patients who were identified for treatment with Tagrisso using Guardant’s test showed progression-free survival rates consistent with those of patients identified using traditional biomarker testing. The company noted that more than 7,000 oncologists have used the test since it was introduced as a laboratory-developed test, and it is covered by Medicare and private payers.
“Obviously, it’ll be more work to get to 100% coverage, and certainly FDA approval will be an important step to convincing some of these payers that are still on the sidelines,” Guardant CEO Helmy Eltoukhy said in a phone interview ahead of the approval.
Encouraging greater physician adoption represents another hurdle that Eltoukhy said FDA approval would help to overcome.
“It takes about seven years for 50% of physicians to adopt a new guideline, so the half life is often very slow, and justifiably so,” he said. That, he added, highlights the importance of educating physicians and sharing the data that are behind the FDA approval of the product with them. “It’s really just another step in the journey toward making sure no patient is left behind in terms of being matched to the right therapies.”
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