Guardant Health Announces Enhancements to Guardant360 Designed to Further Improve Clinical Sensitivity and Utility
REDWOOD CITY, Calif., Nov. 3, 2016 /PRNewswire/ -- Guardant Health announced enhancements to Guardant360, the gold standard for comprehensive liquid biopsy, to help oncologists provide the best possible care for their advanced cancer patients. The new features are designed to increase the test's clinical sensitivity and utility, simplify report interpretation, and expand access to online support services for patients and doctors. They will take effect November 8, 2016.
"These enhancements are a direct result of nearly 30,000 samples we have processed since we introduced Guardant360 in 2014," said Helmy Eltoukhy, Guardant Health's chief executive officer. "With every thousand samples we process, we learn something new about metastatic tumor biology, assay biochemistry, and bioinformatics. We've applied these lessons to dramatically improve the sensitivity, specificity and clinical utility of what is already the market-leading product. These improvements will let us help even more patients."
Guardant360 is the first and most validated comprehensive liquid biopsy commercially available. It provides analysis of all major classes of somatic tumor alterations. The new panel interrogates 73 cancer genes from a simple blood draw, with near-perfect specificity and increased sensitivity for the detection of single nucleotide variants (SNVs), fusions and insertion and deletion alterations (indels) with low allele frequencies.
"Achieving very high specificity, especially at low mutant allele frequency (MAF) is vital for liquid biopsy tests, as more than half of the alterations Guardant360 has reported were detected at an MAF below 0.4%," AmirAli Talasaz, Guardant Health's President and COO said. "The improvements we've made to our Digital Sequencing platform allow us to extend the reportable range and report SNVs and fusions down to MAFs as low as 0.04% and indels down to 0.02% in some cases."
The new 73-gene Guardant360 panel includes more druggable targets and enhanced coverage of clinically important regions. It covers more sensitizing and resistance markers for targeted therapies than any other comprehensive liquid biopsy.
Additionally, the report has been updated to help physicians more quickly identify drug targets detected by Guardant360. A HIPAA-secure online portal and iPhone app allows physicians to access reports on the go, share test results with consulting physicians, and request medical consultations. The report and portal also include greatly enhanced clinical trial reporting. Patients who have received Guardant360 may view their results and access educational resources through myGuardant, the Guardant patient portal.
About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer into a manageable disease. Guardant Health was founded in 2012 by a team with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised more than $200 million 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.
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SOURCE Guardant Health