Tuesday, September 1, 2020

Noridian Continues to Fly Away from MolDx LCDs: Signatera LCD Retirement

Update September 3:  Palmetto MAC has finalized the same LCD that Noridian deleted - Palmetto story here.


Following a chain of events that began in May 2020, when Noridian deleted two LCDs finalized at other MolDx MACs like Palmetto, Noridian has deleted another proposed LCD that remains active elsewhere in the MolDx system.

On August 13, 2020, Noridian posted notice that it was retiring (sic) a proposed LCD DL38343 for the Natera Signatera test for minimal residual disease testing in colon cancer.   See the link here, see a screenshot below.

At least as of September 1, 2020, the corresponding Signatera LCD (DL38290) is actively under proposal at the Palmetto website, where it can remain active as a draft LCD for one year, from October 7, 2019 to October 6, 2020.   Link here.  Screen shot below.

In other cases where Noridian LCDs were deleted, they replaced the "LCD" as proposed with a "coverage article" with similar key text.  (Entry point here).  At least to date, I haven't seen a "coverage article" posted with the key text of the Signatera proposed LCD.  

click to enlarge


Separately, AHRQ is in the midst of a broad assessment of all uses of liquid biopsy, from cancer gene detection for companion diagnostics to screening to minimal residual disease detection [MRD, relapse].  Here.