REDWOOD CITY, Calif., Dec. 2, 2015 /PRNewswire/ -- Guardant Health, the leader in liquid biopsies, announced today that will accelerate the international commercialization of its industry-leading, non-invasive cancer sequencing diagnostic, Guardant360®. It obtained a CE mark for the Guardant360 kit and has partnered with Labco Quality Diagnostics, part of synlab Group, to distribute the test as an exclusive in selected countries in Europe and South America. The first country launch is planned for Spain. Guardant Health will perform all testing at its CLIA-certified and CAP accredited Redwood City, Calif., laboratory.
"Late-stage cancer patients in Europe and South America will now have access to an accurate, comprehensive, and non-invasive genomic cancer test that is already widely used in the United States," said Javier de Echevarria, Labco's Head of Innovation. "This agreement will help diagnose more patients for the proper use of new, targeted therapies in solid tumors, and complements our portfolio of liquid biopsy tests where increased depth and breadth of genomic targets is required for clinical utility."
Labco will serve as the exclusive sales, reimbursement, and distribution partner for Guardant360 in selected countries, and as a non-exclusive in other countries they cover. "We're excited to make Guardant360 more easily accessible to oncologists and patients around the world," said Helmy Eltoukhy, co-founder and CEO of Guardant Health. "Cancer knows no borders. Obtaining a CE mark means Guardant360 can help more patients in more places."
Professor Rafael Rosell, Director of Cancer Biology & Precision Medicine Program at the Catalan Institute of Oncology in Barcelona, and a world-leading medical authority on lung cancer said, "The newer technologies, which include liquid biopsies for cancer, offer patients another method to obtain genomic information when no tissue remains for biopsy, or the tumor has progressed and the existing treatment is no longer effective and we need to quickly know the reason for the resistance. A liquid biopsy test offers a non-invasive and fast method to treat a patient's advanced solid tumor. This is clearly a medical advance in cancer."
With two vials of blood, Guardant360 digitally sequences billions of 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, and may identify targeted therapies for genomic alterations.
Guardant360 is the only cfDNA test that includes all NCCN somatic genomic targets in a single test. Unlike hotspot tests, Guardant360 sequences complete exons in dozens of genes so as not to miss uncommon or rare mutations. The comprehensive diagnostic test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and includes all four major types of pertinent 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 more than $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. The World Economic Forum named Guardant Health a 2015 Technology Pioneer.
About Labco Quality Diagnostics
Labco Quality Diagnostics is part of the synlab Group, a leader in European medical diagnostic services. It has a presence in 35 countries in Europe and Latin America. It has a network of more than 400 laboratories. Backed by its more than 14,000 employees and medical personnel in Europe, the Group offers an extensive range of diagnostic services and performs over 400 million tests every year.
Mark de la Vina
Consort Partners for Guardant Health
SOURCE Guardant Health