Friday, April 27, 2018

Brief Blog: Guardant Publishes Analysis of 7,000 Clinical Lung Cancer LBx

On April 26, 2018, Guardant Health published a peer-reviewed article in Clinical Cancer Research on validation of its plasma-based circulating tumor DNA assay.

The article is online here; open access PDF.   The company also issued a press release here.

To quote briefly:
A retrospective analysis was conducted on a series of 6,948 consecutive lung cancer patients tested with Guardant360. Of those, 543 could be compared to tissue genotyping results performed by other providers. 
The results showed that for treatment-relevant alterations in EGFR, ALK, ROS1, RET, BRAF, MET, and KRAS, the positive concordance of Guardant360 to tissue genotyping was 92-100 percent. 
Furthermore, upon following up on cases that were Guardant360-positive for an ALK fusion but negative in tissue, all patients responded to treatment with a standard-of-care ALK inhibitor.  
The Guardant360 test is under review at FDA, as is the FoundationAct liquid biopsy test