Thursday, September 13, 2018

MolDx Proposes Coverage for Pharmacogenetics Panel: A Win for AltheaDx

Palmetto MolDx has posted new LCDs for its October 1 CAC meeting.   Several are duplicates of LCDs that I already recently highlighted because they will appear in the next CGS MAC MoLDx meeting - here.

But also: a new LCD appears. 

This one proposes coverage for a pharmacogenetics test, NeuroIDgenetix® Test for Depression, draft LCD DL37865.   The test was developed by Althea, a San Diego-based genomics laboratory. 

The LCD is quite detailed and will grant coverage of the gene panel test in patients with treatment resistant depression who are -- under age 65.   The company supported a very well done and large randomized controlled trial (685 patients), Bradley et al.  See Pubmed here, journal open access here.  Although a large age range was eligible for the trial protocol, nearly all patients actually enrolled in the Bradley trial were -- under age 65. 

The LCD provides a very detailed clinical setting review, discussion of unmet needs, and lays out a carefully written clinical and technological assessment of the test. 

Public comment is open from October 1 to November 15.


Note that the lab science of PGx is quite complicated.  If you've never delved into this area, see a review in CAP Today, August 2018, here.  See also an August 2018 Genomeweb article here linking to a Pharmacogenomics paper by Caudle et al. here (PMID 29914287).

Screen shot from Bradley et al.   The publication is open-access.

Genetic testing raised remission rates (red bars)
click to enlarge