Sunday, May 17, 2015

The GeneSight Test: A Wing, a Prayer and 13 Patients

We just published the May issue of The Carlat Psychiatry Report, and the topic is "Biomarkers in Psychiatry."

I contributed an article reviewing the evidence for the GeneSight genetic test, which is being quite heavily marketed as a way to choose the right medications for patients. According to company's website:

"Multiple clinical studies have shown that when clinicians used GeneSight to help guide treatment decisions, patients were twice as likely to respond to the selected medication."

That's misleading, I found. The vast majority of the GeneSight data are based on studies with an unreliable methodology. These were so-called "open label" studies in which patients were non-randomly assigned to two groups: guided treatment vs. unguided treatment. All patients and clinicians knew which patients were assigned to which group, leading to the very real possibility of various biases--along with a heavy helping of the placebo effect.

One single randomized, blinded study has been published (not even properly blinded, since the clinicians knew which patients were in which group). It enrolled 49 patients (25 in the guided group, 24 in the unguided group). There was no significant difference in the depression improvement scores between the groups. There was a secondary analysis of 13 patients showing a potential benefit for those whose meds were categorized by the test as being particularly problematic.

13 patients? I don't think I would use a genetic test based on good results from an N of 13--and I would suggest that you think twice before you do so!

By the way, I'm at the APA meeting in Toronto and will be going to a lecture today sponsored by Assurex, the maker of GeneSight--if I learn anything new I'll let you know.


Anonymous said...

This is of course anecdotal evidence but I have used the test in about 100 patients, with positive results. I've found it to be very helpful in strengthening the therapeutic alliance, particularly among patients who have failed multiple meds and are not enthused about trying another - it can renew hope in some of these cases. Its also been helpful as a rule out, I.e. a patient who is not responding but the medication is in the "green bin" helps me to have a conversation with the patient about alternative explanations, e.g. adherence, differential diagnosis, DDI, etc. I would say the results have been helpful in about 60-70% of my patients tested. There were some initial hiccups with billing but in the last few months seem to have smoothed out.

Anonymous said...

Dr. Carlat, can you share any update from APA?

Daniel Carlat said...

Sure--I saw Chris Bojrab give a talk at the product theater, a good talk, but pretty flimsy on the evidence side, never mentioning that only one blinded randomized trial has been done with pretty unimpressive results. Basically, no new information. But I did hear that they are conducting a larger randomized blinded study so I'm eagerly awaiting those results.

Unknown said...

Dr. Carlat - any new information on this? Thanks

Daniel Carlat said...

In fact, yes. Our march issue of TCPR will focus on the topic. Short answer, no convincing data, still.

Anonymous said...

Dr. Carlat.
I am a new reader of this blog and a novice in studying psychopharmacology (and psychiatry for that matter. I have a question that I would like to ask you or anyone else who might see this comment. It concerns the efficacy and the reliability of tests like Assurex’s Gene Sight Test.
Not too long ago, I began seeing a Psychologist and over the course of our sessions he has mentioned to me on more than one occasion that I might want to meet with the office psychiatrist to discuss medication. My response to him has always been that I am not convinced that I need to be medicated to deal with my current issues and in the past, when I tried various medications over a six-month period I did not find them to be effective. He has tried to persuade me to reconsider by telling me that the office psychiatrist uses this test to determine which medications will work for me
Since learning about this test, I have been trying to learn as much about pharmacogenetic testing as I possibly can. I’ve read the material on your blog and the TCPR, Beth Dailey’s Report from the New England Center for Investigative reporting, and other articles. I have two questions
1. Would it be wise to see a Psychiatrist who relies heavily on the GeneSight test when prescribing medication?
2. Have there been any studies done other than those mentioned in your article “The GeneSight Genetic Test: A Review of the Evidence “that demonstrates the reliability and effectiveness of the Gene Sight test?

Thank You.


Daniel Carlat said...

Hi Ryan,

There is still no compelling evidence that GeneSight test is helpful. We're actually about to publish an issue of The Carlat Psychiatry Report on this very topic, so stay tuned!

Danny Carlat

Anonymous said...

what do you think of Assurex's latest press release about their 1,200 person study? seems like mixed results but not much is shared. They released a press release in early November 2017

Daniel Carlat said...

I just saw the press release and it looks promising. I'll scout around for more information on the methodology and results--the devil will be in the details here. If anyone--whether from the company or not--can direct me to more info, please do so in a comment here or by contacting me directly.