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Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.


Thursday, July 21, 2016

The Gene Genie

In response to my recent post, In the Genes?, I got the following email message:

Dear PsychPractice,
I am a genetic counselor for Assurex Health, the company behind GeneSight. We read your recent blog post comparing Genesight, the Genecept Assay, and Genelex with interest, and I wanted to reach out to you concerning a couple items that you may not have run across in your search of GeneSight.  While much of what you wrote about GeneSight is accurate, some of it is outdated. For example, GeneSight Psychotropic now includes 12 genes, not 5.  Based on the images of the report in your blog, I wonder if perhaps you pulled the images from our Pine Rest (Winner et al, 2013) study?  This study was published in 2013, at a time when GeneSight had 5 genes.  GeneSight has since been updated and currently includes 12 genes.  Additionally, 4 other studies on GeneSight have been published, as well as 2 meta-analyses of these data, all of which were statistically significant. 

If you are interested in receiving any of these studies, please let me know and I will send them to you.  You may also be interested in white papers on GeneSight genes that outline all current research in the context of psychiatric pharmacogenomics.  We have also created white papers on genes we choose not to add to GeneSight due to lack of clinical utility. 

Somehow, I thought I had gotten the image I used, with the list of genes, from the Genesight site. So I went there to look for it again, and I couldn't find it. So then I tracked down where I found the image, by scrolling through my browser history, and it was here:

Winner, Joel G; A prospective, Randomized, Double-Blind Study Assessing the Clinical Impact of Integrated Pharmacogenomic Testing for Major Depressive Disorder; Discovery Medicine; ISSN: 1539-6509; Discov Med 16(89):219-227, November 2013.

I guess it was from the Pine Rest study, and yes, I suppose it is outdated. And I'm pretty sure I looked up the paper because I couldn't find much information about which genes Genesight uses on their site.

I checked again just now, and it took a while for me to find it, but they do have a description of all the genes they're testing, including four new ones.

Pharmacokinetic:

UGT2B15
CYP2D6
CYP2C19
CYP2C9
UGT1A4
CYP3A4
CYP2B6
CYP1A2

Pharmacodynamic:

HLA-A*3101
HLA-B*1502
HTR2A
SLC6A4

The UGTs and HLAs are the new ones.

So now we've got that straightened out. My apologies to Genesight for propagating outdated information.

That said, since publishing that last post, I have used Genesight. Yes, I have. I chose it partially for reasons having to do with insurance coverage.

I had to meet with a rep. I tried to tell him, via email, that all I needed was a test kit. He insisted that we had to meet in person, and that it would only take 15 minutes. We scheduled and rescheduled, mostly because I was annoyed about the waste of my time so I didn't prioritize the time slot. Maybe that sounds obnoxious, but I felt I was giving up my time, and therefore money, so he and his company could make more money. I was paying to make him money.

He asked if he should just bring along a lunch. I flat out said no. When he got to my office, he had a bag with lunch, from Panera. I refused it, and I'm really proud of this fact because I was super hungry.

The meeting took closer to 40 minutes, with most of my time spent sitting quietly and waiting while the rep talked on the phone to his IT people, to figure out the new tablet system they were using. When the rep did talk to me, there was emphasis on the fact that the tests are covered by medicare. Maybe that makes them more respectable. I don't know. I was also told I'd be receiving 10 more kits in the mail shortly. I was encouraged to use them on new patients, and asked about when I do my chart review, in the mornings or evenings. I tried to explain that I don't have a high volume practice, and it doesn't work that way. He also mentioned something about my EMR, and looked a bit nonplussed when I nodded towards my file cabinet and said, "I don't use one."

I did the test on a Monday. You do two buccal swabs-1 per cheek, 10 seconds each. Then you put the swabs in an envelope and seal it. You add a consent form and the swab envelope to a larger envelope, seal that, and send it out via Fedex-it's already labeled and paid for overnight shipment. This sounded easy, but I wanted it sent off that day, my doorman wasn't sure when or whether Fedex would be in the building, and the closest Fedex drop box had been shut down some time ago. So I wandered around a bit til I found a place. More lost time and money. I had tried to contact Fedex to come pick it up, but their site didn't work properly, so I had to wander.

Also, it was a little confusing, because you don't include an order form. Instead, you login to your Genesight account and order the test there (You can print out and use an order form, but only if you don't use the online system). They give you an order number, but there's nowhere to record it on anything you mail in. I wrote it on the swab envelope, anyway.

The results came in at 10pm on Wednesday night, which is probably within the 36 hour turnover time. I can't get into the clinical details, but the test results were about as helpful as I expected. The pharmacokinetic stuff was fair. They suggested some dose adjustments that might be helpful. They also yellow-boxed, meaning use, but with caution, a couple meds that have caused serious side effects in this patient, in the past.

The pharmacodynamic stuff was not particularly good. Meds were recommended that have been of little or no use in the past, or have actually had deleterious effects. I didn't expect much of this aspect, so I wasn't too disappointed. I already knew that genetic testing that's supposed to predict which drugs will be helpful is not ready for prime time, yet.

The best I can say for Genesight, so far, is that it made one potentially useful suggestion, and it seems to be covered by insurance, or if it isn't, it has a decent financial assistance plan, with patients who make less than $50K per year paying $20 for testing. Will I use it again? Hard to say.


David Bowie: The Jean Genie







1 comment:

  1. GeneSight reps completely devoid of properly derived scientific material. I never use this stuff. Shame the company uses this technology at the psychiatrist-patient level. Should be utilized to design better pharmacologic agents.

    ReplyDelete