Thursday, July 12, 2018

MolDX Posts Final LCD For Guardant G360 Gene Panel Liquid Biopsy Test

MolDx has posted the final version of a positive coverage LCD for the Guardant G360 gene panel liquid biopsy test, with coverage for advanced lung cancer patients.

Proposed coverage was initially posted in May 2017 (see here).   Finalization was likely delayed due to the CMS NCD for next generation sequencing in cancer patients, which was under public comment and CMS decision-making from November to March.

A live link to the LCD is here for L37699.  The public notice period started July 12 and the LCD is effective on August 27, 2018.


Coverage falls under two scenarios:

  • At Diagnosis - when results for EGFR, ALK/ROS1, BRAF are not available AND tissue testing is infeasible (e.g. biopsy contraindicated or insufficient tissue);
  • At Progression - for progression on or after chemotherapy or immunotherapy for patients who lack tumor typing for EGFR, ALK/ROS1, BRAF or for patients progressing on TKIs.
For full details see LCD.   Recent NCCN guidelines for use of LBx are cited explicitly.  

The LCD has 21 literature citations.   MolDx also published a lengthy document responding to public comments over the past year.   See A56038, here.

Guardant Health

Guardant Health has announced clinical trial collaborations with BMS, AstraZeneca, Merck, Merck KGaA, and Pfizer (here), and is being used in an important basket trial in Japan (here).  The company had 29 abstracts at ASCO (here) and recently published the large accuracy comparison between tissue and liquid biopsy (here).  For a press release on the new LCD, here.

In the Cloud

I've also put the PDF LCD and PDF Article in the cloud in a zip file, here.  


Nerd Note

For the last several years, most MolDx LCDs have featured an increasingly detailed analytical validity table and discussion within the LCD body.  See for example last fall's AlloSure LCD.   Although the G360 test underwent detailed technical analysis by MolDx, this LCD doesn't include the detailed analytical performance data that MolDx has been including in LCDs.  Possibly this is a new pivot in the LCD template used by MolDx.