Published results of a liquid biopsy study in lung cancer patients could lead oncologists to prioritize blood-based genomic sequencing over traditional tissue testing.

Redwood City, California-based Guardant Health said Monday that it had published results of the NILE study, a head-to-head comparison of its Guardant360 liquid biopsy assay against standard-of-care tissue testing in patients with metastatic non-small cell lung cancer, or mNSCLC, to find biomarkers recommended by treatment guidelines. The study found that results for the two methods were concordant in more than 90 percent of cases, with liquid biopsy finding more targetable mutations and in a faster time frame: a median of nine days, compared with 15 days for tissue testing.

Based on interviews with oncologists, Cannacord analyst Mark Massaro wrote in a note to clients Tuesday that the doctors indicated the NILE study “may usher in a blood-first paradigm” in testing, particularly given the ability to find more mutations and do so more quickly. Tissue biopsy still has some advantages – such as broad mutation coverage and ability to measure tumor mutation burden – but he wrote that liquid biopsy’s advantages can’t be ignored. These include faster results, ability to detect more mutations and to detect disease beyond specific locations.

Shares of Guardant were up more than 3 percent Tuesday in midday trading on the Nasdaq.

The study was designed to look for the biomarkers recommended for guiding treatment, namely EGFR, ALK, BRAF, RET, ROS1, MET and ERBB2. It looked at 282 patients who received both liquid biopsy and physician-discretion tissue genotyping. Among the 282 patients, tissue testing identified guideline-recommended biomarkers in 60 patients, compared with 77 who underwent liquid biopsy. For targets with Food and Drug Administration-approved drugs – namely EGFR, ALK, ROS1 and BRAF – concordance between the two methods was 98.2 percent, with liquid biopsy yielding a 100 percent positive predictive value. Among those 60 patients with a biomarker discovered through tissue testing, tissue testing alone found the biomarker in only 12, while in 48 the results were concordant with liquid biopsy, thus indicating much higher sensitivity for the latter.

Still, the doctors interviewed by Cannacord do not see liquid biopsy as a “winner-take-all” market, with at least five and perhaps even 15 or more players expected to play a role in the market. Massaro wrote that other companies Cannacord ranks highly include Natera, for its ability to monitor for recurrence and residual disease detection, and Exact Sciences, which is working to develop multiple liquid biopsy tests with the Mayo Clinic. Other companies highlighted include Roche’s Foundation Medicine, GRAIL, Adaptive Biotechnologies, Tempus, Freenome and Biodesix.

Photo: jxfzsy, Getty Images



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