PRIME Care Time-To-Event Analysis
When & where was the post-hoc analysis published?
Published in the October 30, 2025 edition of Frontiers of Pharmacology
Is a new sample required for a patient who would like the Psych 5.0 upgrade?
This will depend on the version of the patient’s previous GeneSight report.
If the patient has the most recent GeneSight report (Psych 4.3, released May 18th, 2024), no new sample is needed.
If the report is from an earlier version, a new sample will be required.
___ people in the US aged 65+ experience depression
7M
What is a 'meta-analysis?'
A study of studies. Combines the results of multiple independent studies on the same topic to provide a more comprehensive, overall conclusion on the topic.
What does it mean when a medication is categorized into the gray bin?
Based on current literature, there are no proven genetic markers for these medications. However, these medications may be effective choices based on other clinical factors.
What role did Myriad play in the PRIME Care Time-To-Event analysis?
Myriad provided the GeneSight testing for the PRIME Care RCT.
Myriad collaborated with VA investigators to design this Time-To-Event analysis of the publicly available data-set
What is Tardive Dyskinesia (TD) ?
Tardive dyskinesia (TD) is a movement disorder that involves involuntary, repetitive movements, most often of the face, tongue, lips, and sometimes the trunk or limbs. TD is most commonly caused by long-term use of dopamine receptor–blocking medications, especially antipsychotics (neuroleptics).
According to the National Center for Health Statistics, in the past 30 days...
____ of older people used at least one prescription drug.
____ of older people used 3 or more prescription drugs.
____ of older people used 5 or more prescription drugs.
In the past 30 days...
89% of older people used at least one prescription drug.
68% of older people used 3 or more prescription drugs.
41% of older people used 5 or more prescription drugs.
How many clinical studies are included in the meta-analysis?
The study analyzed six prospective, controlled trials to assess the impact of the GeneSight Psychotropic test on clinical outcomes in a total of 3,532 unique adults with MDD who had at least one prior treatment failure.
What is polypharmacy and how can GeneSight help reduce polypharmacy?
The simultaneous use of multiple medications.
Elderly patients have greater risk of adverse drug-drug interactions, consequent of polypharmacy. GeneSight aims to guide prescribing choices that may ultimately result in reducing the number of medications / decreasing risk.
What was the study objective?
This post-hoc analysis of the PRIME Care study explored whether having access to the GeneSight test results increased the rate of remission and response over time and if the effect was persistent.
Where are the TD medications listed on the report? What is this section called?
These medications will be added after the antipsychotics section of the GeneSight report under a ‘Medications Used for Tardive Dyskinesia’ section and will appear on the same page as Mood Stabilizers.
Depression may present differently among the elderly patient population, such as...
Cognitive problems/loss of concentration
Loss of interest in activities
Hopelessness about the future
Nagging aches/pains
Digestive problems
Sleep disturbance
Where are the meta-analysis results published?
Journal of Clinical Psychopharmacology
Explain GeneSight's patented weighted multi-gene approach
The patented GeneSight weighted multi-gene approach not only focuses on the primary pathway in which a drug metabolizes, but reviews the multiple pathways and weighs them against one another based on significance
What are the key findings of the PRIME Care Time-To-Event Analysis?
Patients in the GeneSight arm had faster initial remission and response than those in the treatment as usual (TAU) arm. Patients in the GeneSight arm were 27% more likely to achieve remission & 21% more likely to achieve response.
The benefit of GeneSight testing persisted over the 24-weeks of the study
As a part of Psych 5.0 roll out, updates were made to these three genes, following a comprehensive analysis of peer-reviewed literature
UGT2B15, CYP3A4 & HTR2A
What are some challenges providers may face associated with treating elderly patients for depression?
Increased polypharmacy and consequent risk for increased drug-drug interactions
Reduced medication adherence
Higher rates of side effects
Greater risk of adverse events, such as falls, due to co-existing conditions
Summarize the meta-analysis findings
The meta-analysis showed that when GeneSight Psychotropic test results were available to treating clinicians, there were significant improvements in response and remission rates for patients with MDD, compared to treatment as usual (TAU).
41% relative improvement in pooled remission rates / 30% relative improvement in pooled response rates compared to TAU
What happens with a patient's genetic material after the test is completed?
We remove all personal identifiers from the patient’s samples soon after they are received in the lab. Later, the de-identified samples may be used for test validation, education, and research and development. All patient samples are disposed after 60 days.
Patients can also request that their sample be destroyed immediately by contacting us at 866.260.2394.
What is one potential talk track / guiding question to drive the conversation with a provider to share the study findings?
When you’re treating patients with depression, how often do you find that it takes months to find a medication that works? That trial-and-error process can be long and frustrating for both you and your patients.
The GeneSight test is a tool that can help inform medication selection, and a recent analysis showed that when clinicians had access to the GeneSight test, patients with MDD had faster initial remission and response compared to treatment as usual (TAU)
Summarize the updates for Psych 5.0
Two new medications for tardive-dyskinesia (TD) : valbenazine (Ingrezza®) and deutetrabenazine (Austedo®)
Modification of UGT2B15 genotype to phenotype translation as well as HTR2A phenotype and phenotype description. Update in alleles detected in CYP3A4 gene.
Updated format to MTHFR panel
Verbalize the venlafaxine study findings
When comparing CYP2D6 poor metabolizers prescribed venlafaxine, it was discovered that serum levels of venlafaxine among elderly (>65) patients were 8X greater compared to younger adult (<40) blood serum levels.
What’s the difference between this meta-analysis and the other externally conducted meta-analyses?
The current meta-analysis is GeneSight specific, and the results of the study are only applicable to the GeneSight test.
The externally conducted meta-analyses include studies from multiple PGx tests, and the results support the use of PGx in depression in general rather than focusing on a specific test.
Results of the general PGx meta-analyses in depression generally find similar results to the current meta-analysis; however, it is important to keep in mind that the GeneSight studies used in this meta-analysis usually make up at least some portion of the studies included in the externally conducted meta-analyses.
Summarize the medication switching post-hoc analysis
A GUIDED sub-analysis was conducted on patients who were taking medications with GDIs at baseline and then had their medications switched. Among this group, a larger proportion of patients in the GeneSight arm were switched to medications with no gene-drug interactions by week 8 (66%) compared to TAU (20%).