Guardant Health Receives Investigational Device Exemption Approval from the FDA to Support Merck KGaA, Darmstadt, Germany Tepotinib Study

September 26, 2017

REDWOOD CITY, Calif., Sept. 26, 2017 /PRNewswire/ -- Guardant Health announced that it received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to provide genomic testing for a clinical trial investigating the small molecule, c-Met kinase inhibitor tepotinib. Under a collaboration agreement between Guardant Health and Merck KGaA, Darmstadt, Germany—which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada—the Guardant360® CDx Test will be the liquid biopsy option to identify advanced lung cancer patients with MET exon 14 skipping alterations who may qualify for the ongoing Phase II tepotinib trial.

"This is an important milestone for Guardant Health in our ongoing work with the FDA," said Helmy Eltoukhy, Guardant Health's CEO. "We are very excited to partner with Merck KGaA, Darmstadt, Germany to help accelerate their study of this promising targeted agent."

Clinical trial progress is often impeded by the need to collect tumor tissue samples for genotyping. Difficulty in acquiring these samples can slow trial enrollment and prevent researchers from quickly and easily identifying the right patients. Comprehensive analysis of genomic alterations in cancer found in circulating tumor DNA obtained through a simple blood draw can eliminate the need for an invasive biopsy to acquire a tissue specimen and accelerate clinical trial enrollment.

The Guardant360® assay is the most ordered comprehensive liquid biopsy. It was introduced in 2014 and has since been used more than 50,000 times by more than 3,500 oncologists. The Guardant360 assay includes 73 genes associated with cancer, and can detect single nucleotide variants, insertion and deletion events, copy number amplifications, and fusions.

About Guardant Health
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading investors. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc.

SOURCE Guardant Health

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