GeneSight FAQs from Clinicians
What clinical backing do you have?
We have 7 clinical studies published in peer-reviewed journals, including the largest pharmacogenomic clinical trial in the mental health space, our GUIDED study.
GeneSight is the only psychiatric pharmacogenomic test backed by such extensive research
Is the GeneSight test FDA regulated/approved?
No - The GeneSight Test is a laboratory developed test and does not require FDA approval. Our lab is accredited by CLIA and CAP.
Why does the GeneSight test have to be ordered through a clinician?
A healthcare provider is critical as patients should never change prescription medications on their own. The GeneSight test is intended to supplement other information considered as part of a comprehensive medical assessment, like potential drug/drug interactions, age, weight, lifestyle, etc.
What is an SSRI?
Selective Serotonin Reuptake Inhibitor
Aren't all PGx tests the same?
GeneSight is backed by science (GUIDED + 6 other published studies)
CPGx
1.5 million patients tested - strong industry reputation
Report Format
What are some patient populations that are ideal for GeneSight testing?
Patients that are sensitive to medications, new patients with previous medication failures, SSRI switches, and patients that are 65+
What is CPGx? Verbalize it.
Combinatorial Pharmacogenomics
The patented GeneSight CPGx approach not only focuses on the primary pathway in which a drug metabolizes through but looks at the multiple pathways and weights them against each other based on significance.
"My insurance told me that they require a prior authorization for GeneSight testing"
What type of insuance do you have?
The only insurance that requires a prior authorization is UHC.
We have an internal billing program - GeneSight promise + FAP
Name 2 of our competitors
OneOme
GenoMind
Millennium
Admera
PGx Testing isn't ready for prime time
GUIDED/Science
Local Coverage Determination
PGx language in FDA package inserts
How successful is GeneSight testing?
According to our GUIDED study when patents clinicians used the GeneSight test the patients were 50% more likely to achieve remission than those patients in the treatment as usual group.
Why is the GeneSight test important?
The Genesight test is important because genetic variability is undermining clinician’s medication selection. Our test provides information about your patient that may help you avoid multiple medication trials and is a powerful tool to augment your knowledge, experience, and passion for your patients.
"I already looked my provider isn't registered"
Did you look at our Find a Provider Portal?
That is only a small percentage of clinicians that are registered with us. I'm happy to search to see if your provider is registered - what is their last name?
How many patients entered the GUIDED study on medications in the red bin?
213
Provide two facts that back up why clinicians should be using GeneSight testing?
SLC6A4
Star*D - Less than 40% of patients achieve remission from first prescribed medication
Star*D - with each failed medication trial, a patients treatment intolerance increases.
GUIDED
Medication Switching
"I just prescribe the green category medications, because they will work best?"
Medications in the green/use as directed category mean that there is no genetic reason that these medications shouldn't work, however, other prescribing factors should still be incorporated into medication selection.
GeneSight is a piece of the puzzle.
Your report doesn't have as many genes as other companies
Correct - genes and medications added to our report go through a rigorous review and are clinically relevant to psychotropic medications
Shouldn't the medication that worked for my family member work for me?
Your genes are unique to you. You and a family member may respond or react differently to the same medication. The GeneSight test uses your genetic information to provide options for your doctor.
What are you registering me for?
Our secure GeneSight web portal where orders are placed and results are viewed
Ask some insightful questions to better understand how GeneSight will be implemented into a practice.
What types of patients are you planning on using testing for?
How familiar are you with the GeneSight test?
How often do you have a patient fail their first medication prescribed for psychotropic disorders?
What do you do 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.
Why is GUIDED different from our previous clinical trials?
It included primary care clinicians - previous clinical trials only included psychiatrist.
Should I call my insurance to see if my test is covered?
You can call your insurance company, however, they might tell you that the GeneSight test is out of network.
For this reason, we have our internal billing program and you are covered under our GeneSight promise.
Are you comfortable with a $330 out of pocket cost for testing?
What do these acronyms mean?
RBM
MSC
ABD
MSL
Regional Business Manager
Molecular Sales Consultant
Area Business Manager
Medical Science Liaison
My office doesn't have time to order the GeneSight test
Our portal has been updated with fewer steps
DTP
Potential time saving on call backs, pharmacy interactions, and medication switching