Guardant Health Appoints Mort Minaee, Former Roche Senior Director, as VP of Regulatory Affairs

Role created to expand company's continued commitment to quality and clinical impact of cell-free tumor DNA

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May 07, 2015, 06:00 ET

REDWOOD CITY, Calif., May 7, 2015 /PRNewswire/ -- Guardant Health®, the leader in biopsy-free tumor genomic testing, today announced the hire of Mort Minaee as Vice President of Regulatory Affairs. Minaee brings to Guardant more than 25 years of experience in regulatory, clinical affairs and quality systems in the medical device industry and a proven track record of expedient FDA product approvals and registrations. He was most recently the Senior Director of Regulatory Affairs at Roche-Ventana Medical Systems.

"Mort comes to Guardant as an increasing number of oncologists and cancer centers adopt Guardant360®, which provides a more effective and accurate means of tumor genomic testing without the cost and risk associated with tissue biopsies," says Guardant Health President and COO AmirAli Talasaz. "His strong regulatory expertise will increase the clinical reach of cell-free DNA tumor testing as a transformative tool for oncologists, patients and pharmaceutical companies to stay one step ahead of the disease."

The hire is the latest example of Guardant Health's strong commitment to clinical validation, quality, and utility of Guardant360, which showed dramatic results on patient care in a recent MD Anderson Cancer Center study. Also, Guardant Health last month presented findings at the American Association for Cancer Research (AACR) Annual Meeting for more than 2,000 patient samples highlighting the accuracy and near-perfect specificity across multiple cancer types. For many patients, Guardant360 was able to find targetable mutations with documented response where tumor tissue was either unavailable or inadequate for providing further options.

"Guardant Health's achievement of reaching the highest level of specificity with high sensitivity is impressive, demonstrating that this pioneering company is indeed the leader in biopsy-free, tumor genomic testing," said Minaee. "While other companies talk about this technology as the future, Guardant Health has shown with powerful results over the past year that it is already delivering on its promise. Seeing Guardant360 provide greater options for cancer patients today is what made me want to join this team."

With only two vials of blood, Guardant360 digitally sequences more than 10 billion genomic data points to identify tumor genomic alterations at greater than 99.9999 percent specificity. Actionable genomic alterations and associated treatments are identified in about half the turnaround-time – and with none of the risk – of tissue biopsies. The Guardant360 platform gives oncologists and patients a simpler, faster and more accurate perspective of their treatment options, resulting in targeted therapies for genomic alterations.

About Guardant Health

Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics and cancer diagnostics. The company has raised $100 million in funding from leading venture capital firms and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.

Media Contact:
Mark de la Vina
Consort Partners for Guardant Health
Email: [email protected]
Phone: 415-282-4795

SOURCE Guardant Health