AACR: Resolution Bio assay beats out Guardant360 in retrospective study of complex NSCLC gene fusions

Red blood cells
Of the 13 cases in which an oncogenic fusion was detected in plasma by Resolution Bioscience's test, the retrospective study showed 89% of patients with productive gene fusions and 75% of patients with non-productive fusions later responded to treatments with tyrosine kinase inhibitor therapies. (Wikimedia Commons)

Resolution Bioscience unveiled the results of a retrospective study comparing its ctDx-Lung liquid biopsy to the Guardant360 blood test, which found that its assay was able to detect a greater number of actionable gene fusion mutations in non-small cell lung cancer tumors.

Conducted by researchers at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Resolution, the blinded study analyzed a cohort of 169 patients who had been screened with Guardant Health’s tumor genome sequencing test.

Researchers then used Resolution’s assay—which also focuses on circulating, cell-free DNA—to examine 16 cases that had a genetic rearrangement in their tumors, along with banked plasma samples.

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They found that the ctDx-Lung assay identified 13 out of 16 actionable gene fusion mutations in plasma, with higher allele frequencies, compared to the seven fusions detected by the Guardant360 test.

Of those 13 cases with an oncogenic gene fusion, 89% of patients with productive fusions and 75% of patients with non-productive fusions responded to tyrosine kinase inhibitor therapies, according to Resolution, which said the study is undergoing additional unblinding to explore false negative cases.

The poster (PDF) and results were presented at the annual meeting of the American Association for Cancer Research in Atlanta.

“These results prove our kits can be run at the leading cancer centers around the world, enabling more scientists to detect more of these actionable mutations, which will soon transform the way we diagnose, treat and monitor devastating diseases like NSCLC,” Resolution CEO Mark Li said in a statement.

RELATED: Guardant’s blood test outperforms standard tissue biopsy in landmark NSCLC study

Meanwhile, Guardant recently demonstrated how its lung cancer blood test was able to outperform standard tissue-based biopsies in a head-to-head study, with Guardant360 delivering similar genomic results with more accuracy.

Guardant says the research makes the case for blood-based genomic testing to be performed first for all newly diagnosed lung cancer patients—with total turnaround time for test results cut from a median of 15 days with tissue-based assays to just nine with the former Fierce 15 winner’s blood test.

Guardant also recently received a draft local coverage determination (LCD) for its Guardant360 test, expanding Medicare coverage from advanced NSCLC to more than a dozen types of solid tumors with genomic targets.

The draft LCD, from the Medicare administrative contractor Palmetto GBA, applies to advanced cancer patients who have next-generation sequencing coverage for tumor tissue-based tests but have insufficient tissue samples available, including from cancers that have spread to the deep viscera, bone or brain.  

“This is an important step toward making sure all Medicare beneficiaries with advanced cancer have timely access to guideline-recommended treatment options,” Guardant Health co-founder and CEO Helmy Eltoukhy said in a statement.

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