US-based Guardant Health has announced the US commercial launch of its Guardant360 blood test for real-time cancer patient treatment management.
The Guardant360 blood test, which is now widely commercially available following recent successful introduction to early access partners, comprehensively sequences a patient’s cancer in real-time to aid oncologists in making more informed, personalized treatment decisions without a tissue biopsy.
Built on Digital Sequencing, Guardant360 provides high-fidelity tumor sequencing information at the single-molecule level. Digital Sequencing is a proprietary method of capturing and genetically profiling trace fragments of tumor DNA that are shed into the blood stream (cell-free DNA).
According to Guardant Health, initial results from 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.
The Guardant360 clinical validation results include the company’s interim data from its cell-free DNA study encompassing 300 patients across the five 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.
Guardant Health CEO and co-founder Helmy Eltoukhy said that 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.
"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," Eltoukhy added.
Guardant Health will release four abstracts highlighting the clinical significance of the Guardant360 test at the 2014 ASCO Annual Meeting, from 30 May to 3 June in Chicago, Illinois.