Guardant Health Announces US Commercial Launch of Guardant360™: A Breakthrough Blood Test for Real-Time Cancer Patient Treatment Management

REDWOOD CITY, Calif., May 30, 2014 /PRNewswire/ -- Guardant Health, a healthcare company focused on the development and commercialization of oncology diagnostic products, announced today that its premier product, Guardant360™ is now widely commercially available following recent successful introduction to early access partners.

Guardant360 is a first-in-kind blood test that comprehensively sequences a patient's cancer in real-time to aid oncologists in making more informed, personalized treatment decisions without a tissue biopsy. Guardant360 is built on Digital Sequencing™, a proprietary method of capturing and genetically profiling trace fragments of tumor DNA that are shed into the blood stream ("cell-free DNA"), and provides high-fidelity tumor sequencing information at the single-molecule level. The initial results of the ongoing GUARDANT360 early access program continue to demonstrate strong clinical utility with a number of patients experiencing improvement from associated treatments based on identified genomic alterations.

Four abstracts highlighting the clinical significance of the Guardant360 test will be released at the 2014 ASCO Annual Meeting May 30^th – June 3^rd in Chicago, Illinois (see Schedule of Poster Presentations, below).

The Guardant360 clinical validation results include Guardant Health's interim data from its cell-free DNA study encompassing 300 patients across the 5 most prevalent indications: colorectal, lung, breast, melanoma and prostate cancers. The concordance of tumor biopsy-derived alterations to those in blood were found to approach 90% when tumor biopsies were taken concurrently with the blood draw.

"These studies highlight the importance of having a non-invasive test that can be performed when additional biopsies are not an option due to the risk, cost, or time," said Helmy Eltoukhy, Ph.D., Co-founder and Chief Executive Officer of Guardant Health. "As a simple blood test, it provides physicians with a streamlined, cost-effective method to identify genomic alterations that can comprehensively influence a patient's therapy response."

Schedule of Poster Presentations at ASCO featuring Guardant Health:

1. Circulating tumor DNA (ctDNA) as a molecular monitoring tool in metastatic breast cancer (MBC).
   Date and Time: Saturday, May 31, 1:15PM – 5:00PM
   Abstract #: 11093
   Session: General Poster
   Location: S Hall A2
   Presenter: Laura Katherine Austin
   Collaborator: Kimmel Cancer Center at Thomas Jefferson University
   
   
2. Frequency of concurrent gen mutations and copy number alterations in circulating cell-free DNA (cfDNA) from refractory metastatic CRC patients.
   Date and Time:  Saturday, May 31, 1:15PM - 5:00PM
   Abstract #: 11117
   Session: General Poster
   Locations: S Hall A2
   Presenter: M. Pia Morelli
   Collaborator: The University of Texas MD Anderson Cancer Center
   
   
3. Identification of multiple informative genomic mutations by deep sequencing of circulating cell-free tumor DNA in plasma of metastatic melanoma patients.
   Date and Time: Monday, June 2, 8:00AM – 11:00AM
   Abstract #: 9018
   Session: Poster Highlight
   Location: E354b
   Presenter: Dave S. B. Hoon
   Collaborator: John Wayne Cancer Institute
   
   
4. Use of GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility.
   Abstract #: e22041
   Session: Publication Only – available online at:             http://abstracts.asco.org/144/AbstView_144_135280.html

About Guardant Health

Guardant Health is focused on developing breakthrough diagnostic technologies that possess the ability to transform cancer from a terminal illness to a manageable disease.  Guardant was founded in 2012 by a team of entrepreneurs with high-ranking expertise in next-generation sequencing, single-cell genomics and cancer diagnostics.  Guardant Health is committed to contributing a positive significant impact on patient health through cutting-edge technology that addresses long-standing unmet needs in oncology. https://www.guardanthealth.com

Please Visit Us at ASCO at Booth #19156

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SOURCE Guardant Health