Guardant360 Lung-Cancer Assay Beats Tissue Genotyping In NILE
New trial results show Guardant Health's Guardant360 largest cell-free DNA assay rapidly identifies biomarkers for metastatic non-small cell lung cancer associated with specific therapies at least as accurately as standard-of-care tissue genotyping.
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The companies expect the Guardant360 CDx liquid-biopsy test to identify patients who will benefit from amivantamab, Janssen’s investigational drug for non-small cell lung cancer.
Liquid biopsy is a rapidly developing noninvasive technology for the early detection of cancer. Multiple companies have entered clinical testing, using mostly blood to detect circulating tumor cells and/or circulating tumor DNA. But urine and even cerebral spinal fluid are promising liquids too. Regardless of the fluid, testing costs a fraction of a traditional, invasive tissue biopsy and offers much quicker results.
The company stopped shipping Alaris in early 2020 after the FDA requested a new 510(k) for modifications and the device has been the subject of several recalls since then.