The Guardant360 Assay Receives Expedited Access Pathway Designation for Breakthrough Devices From FDA

REDWOOD CITY, Calif., Feb. 15, 2018 /PRNewswire/ -- The Guardant360® assay, the leading comprehensive liquid biopsy, received an Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration, Guardant Health announced. If approved, the Guardant360 assay could be the first FDA-approved comprehensive liquid biopsy.

"This marks a critical milestone for our work with the FDA, and an important moment in the development of comprehensive liquid biopsies," said Guardant Health Co-Founder and President AmirAli Talasaz. "This designation allows us to work hand in hand with the FDA as we prepare our submission to the FDA later this year. Accomplishing this goal will be critical as we deepen our capabilities for our partners in the biopharma industry."

Guardant360 is a comprehensive liquid biopsy that helps oncologists select the optimal treatment for advanced cancer patients without the need for an invasive tissue biopsy. Guardant360 has been extensively validated and is supported by more than 20 clinical outcome studies. It is available in more than 30 countries.

The Expedited Access Pathway is intended to speed review of breakthrough technologies and medical devices that serve unmet medical needs. Through the program, the FDA will work with Guardant Health to finalize its data development plan, providing access to senior FDA officials and facilitating a collaborative, cross-disciplinary review. The FDA is expected to replace the EAP soon with its new Breakthrough Devices Program. Premarket Approval Applications from EAP-designated devices typically receive priority review at the FDA, and all submissions designated as Breakthrough Devices are set to receive priority review.

"Our FDA submission for Guardant360 is Guardant Health's top priority for 2018," said Guardant Health Co-Founder and CEO Helmy Eltoukhy. "The ability to tap into the FDA's expertise and support will be invaluable as we work toward our goal of seeking the first FDA approval for a comprehensive liquid biopsy."

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 and available in more than 30 countries. 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. Learn more at www.guardanthealth.com.

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SOURCE Guardant Health