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.
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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).
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Screen shot from Bradley et al. The publication is open-access.
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| Genetic testing raised remission rates (red bars) |
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| click to enlarge |
