Following the FDA’s approval of Guardant Health’s liquid biopsy comprehensive tumor mutation profiling across all solid cancers;

Dara Lo, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:

“This is a landmark approval for cancer testing as Guardant Health’s liquid biopsy is the first of its kind to genetically profile tumors anywhere in the body from a single blood draw. Despite the negative impact of COVID-19 across many industries, Guardant Health has managed to report an increase in revenue of 23% in the second quarter of 2020 over the corresponding period of 2019. With this approval, GlobalData expects increase in revenues for Guardant Health to continue.

“The approval allows the device to be used as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) based on the presence of mutations in the gene EGFR. With lung cancer currently leading cancer-related deaths worldwide, the need for this test cannot be stressed enough as NSCLC comprises 80-90% of all lung cancers.

“Furthermore, liquid biopsy is revolutionizing cancer tests as it is non-invasive, precise and provides faster turnaround time for results compared to traditional solid tumor biopsy. With 27-31% of NSCLC patients being unable to provide a suitable specimen upon diagnosis, liquid biopsies are beginning to be a necessity as a minimally invasive alternative method.”

For more information, send your questions to Rebecca Panks, PR Executive at GlobalData (pr@globaldata.com)