Well, they said on Thursday’s earnings call that they thought approval was “very close”, and it looks like they got the FDA approval for Guardant360 now
https://www.globenewswire.com/news-release/2020/08/07/207518…
The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat. Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test,” said Helmy Eltoukhy, Guardant Health CEO. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx.
Will be interesting to see how much this moves the stock on Monday
-mekong