Guardant Successful Nile Study Complete

Hi All,

In midst of today’s earnings bonanza, Guardant has just announced that the NILE study was completed successfully, matching biopsy testing in non small cell lung cancer. Good news!…


Investigators found that Guardant360 identified guideline recommended-biomarkers in 77 patients; tissue testing identified them in 60. Importantly, for each patient in whom Guardant360 identified a target of an FDA-approved drug (EGFR, ALK, BRAF, ROS1), tissue also detected the same alteration. Additionally, the median time to results for Guardant360 was much shorter than for tissue testing. Guardant360 results were reported in an average of 9 days, versus 15 days for tissue. The NILE study met its primary endpoint of demonstrating comparable performance of Guardant360 to tissue.



Great stuff! And to think I nearly added to my position the day before. I now just doubled my 1.5% stake to 3%. Better late than never…

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Thanks for posting this. Somehow all my screens to catch news about Guardant didn’t catch this one.

This has pretty huge clinical implications. Lung biopsies are no joke (which has got to be part of the reason GH went for this indication), to be able to diagnose and get genomic markers all in one go, in about half the time of tissue biopsy, and without the morbidity of surgery or interventional radiology is just huge…huge huge huge. I’ll be very interested to see the clinical uptake. I’m going to guess that the people who order this are the oncologists and not the thoracic surgeons or interventional radiologist.

issues I see that might limit the tests uptake.

  1. Not all lung tumors are non-small cell lung cancer. I’ll be interested to see how this fits into a diagnosis pathway.

  2. This is test was comparing, “advanced” non-small cell lung cancer. I haven’t been able to access the study yet so I’m not entirely sure how much that narrows the indication.

Random side note, Just this last month I was involved in an IR case to biopsy a lung mass that resulted in fairly significant pulmonary hemorrhage (bleeding in the lungs) and 20 minutes of scrambling to keep the patient from having serious complications.