How do I request Geneticure kits for my office?
Once you have registered for an account by clicking the link on the top of the website (Activate | Login), you will have an opportunity to request Geneticure kits.
What is the evidence for the test?
Thousands of peer-reviewed research articles have been combined in this comprehensive panel. The efficacy of the test was then vetted with 2 retrospective, and 1 prospective randomized clinical trial. Our publications can be viewed here: http://geneticure.devicepharm.net/providers/#costs-data
Will my patient need a Geneticure account?
Activation of kits can be done by providers. No action by the patient will be needed when providers activate kits on behalf of patients.
How do I integrate Geneticure into my practice?
Please click the link on the top of the website (Activate Kit | Login) and register for a new account as a provider. We will be in touch regarding next steps once we verify your information.
How do I share this information with my personal healthcare provider?
When your report is available, you can (and should) share a copy with your personal healthcare care provider. You can retrieve a copy of your report on the Geneticure User Portal. Simply login and follow the prompts to download and print a copy of your report. Should your provider want more information about the test, they can find it at www.geneticure.com/providers.
Who is PWNHealth?
We work with an independent provider network, PWNHealth, an outside, independent network of healthcare providers, to review health history and test orders to ensure our customers are receiving the best test for their health concerns. PWN will confirm if testing is right for you and may reach out to you if they have any questions regarding your request for our test. If for some reason our test is not a fit for you after physician review, the cost of your test will be fully refunded, without limitation.
You can reach PWN at email@example.com or 888-494-7333
Why do I need to activate my kit?
Activating your kit initiates the process of a physician overseeing the processing of your request as well as the sample tracking system.
Does your test examine my existing medications and whether new drugs will interact?
Why, yes! Our provider network will look at your medication list and will promptly inform you of any counter-indications of medications you may be taking. Please enter medication names with correct spelling for accurate assessment.
Is Geneticure available outside of the US?
No, but we will in the near future. Stay tuned.
Are there any age restrictions?
Yes. We do not test individuals under the age of 18.
How do I send a specimen?
Collection is simple and painless. Included within the kit are detailed instructions. You will use a cheek swab (which is like a Q-tip with a retractable tip) to rub the inside of your cheek, then place the tip into the sample tubes provided. You will do this 2 times—once for each cheek—so that we will be certain to have enough DNA to perform the test. Be sure to follow the instructions closely and contact us with questions.
What should I do after I am tested?
- Maintain all health regimens and appointments and follow your doctor's orders. We'll work quickly to provide you your test results.
- When you receive your report, share it with your provider and have a conversation about next steps. It is important that you follow your providers medical advice.
Do you need a prescription for this test?
No. Geneticure works with PWNHealth, an independent provider network, that will review your test order and determine whether to authorize the test for you. The cost of this authorization is included in the cost of the collection kit. You will also have the opportunity to speak with a genetic counselor about your test results.
How soon do I need to complete and ship my kit? Do the kits expire?
The kits do expire. The expiration date is printed on the sticker on the outside of the kit.
How do I activate my kit?
Activating your kit initiates the process of a physician overseeing the processing of your request as well as the sample tracking system. To activate your kit go to the Geneticure User Portal. Simply sign in, or for a first time user, register a new account. Once you are signed in please click on "Activate a Kit" and follow the prompts.
What should I do if I forgot to activate my kit before mailing it back?
As long as you still have your kit ID you can still activate your kit. The kit identification code is on the additional sticker provided in the kit box.
How do I find my kit ID?
Within your collection kit you received an extra sticker containing a unique barcode. This is your kit ID. The insert provided with you sample collection kit has the extra sticker already affixed for safe keeping with your medical records. The kit ID sticker is the only unique identifier of your kit. Because we take privacy very seriously, if your kit ID is lost, we will not be able to retrieve it for you.
Are my results confidential?
Absolutely. Geneticure complies with HIPAA (Health Insurance Portability and Accountability Act of 1996). Geneticure goes further by keeping the records of your test coded and deidentified.
How do I receive my report?
Our service is exclusively online. You'll receive your reports through a password-protected account at Geneticure.com. In order to receive reports and participate in the service, you need to have a valid email address that allows you to send and receive messages. You also need access to a computer or mobile device that connects to the Internet.
What is a genetic counselor and what is covered during the genetic counselor consult?
The cost of genetic counseling through PWNHealth is covered with the purchase of your test. With your Geneticure test you will have an opportunity to discuss and better understand your results directly with a genetic counselor. Health professionals from PWNHealth review test requests, identify potential drug-drug interactions, and offer consultation throughout the testing and reporting process. With PWN you can learn the limitations of your test and how to best discuss the results with your doctor before making any changes to your prescriptions. Depending on the test results, you may be required to schedule a genetic counseling session before getting your results. You can reach PWN at firstname.lastname@example.org or 888-494-7333.
When will I get my results?
You can expect to receive your results within 15 days of our lab receiving your sample. Timing can vary based on quality of the sample, transit times, our 3rd party physician approval, among many other factors. You will receive an email notification when your results are ready.
What will my results tell me?
The test generates a list of recommendations in order of evidence-based most-to-least effective. This allows your doctor to examine your whole health and which of the medications should be used based on the additional information they know about you.
How accurate are the results?
Our rigorous quality standards include:
- All samples being processed in CLIA-certified and CAP-accredited labs
- Our DNA collection kits are manufactured in accordance with FDA's Good Manufacturing Practice regulations
- Genotyping is a well-established and a reliable platform is used for for analyzing DNA
- A team of scientists and medical experts that use a rigorous process to develop and design each report, ensuring validity and ease of use.
What is the difference between this test and other genetic tests (e.g. 23andMe)?
Unlike novelty or disease-risk tests, this test focusses only on hypertension and only analyzes the genes most-vetted by research to impact response to blood pressure medications. We also use a patent-pending multi-gene algorithm that analyzes the variants both independently and in combination, so that the recommendations are a result of a networked, integrated approach.
Who might want this test?
Individuals with newly diagnosed hypertension that are interested in avoiding the "trial and error" approach for finding the best medication.
Individuals who have already been treated for hypertension can also benefit from our test. Most medications have a bell-curve response meaning some medications may do nothing to impact blood pressure for certain people and for others this same medication could cause blood pressure to go down, or even up. This means many patients may be taking medications that are either ineffective or potentially even counter productive. With the guidance of your doctor, the Geneticure test could help you reduce the number of medications you are taking or optimize them.
Is this test validated by science?
Yes. In Geneticure’s retrospective clinical trial, the data suggests the Geneticure approach is associated with a 7.1mm Hg lower systolic blood pressure (top number) and 5.4mm Hg lower diastolic Blood Pressure (bottom number). This is meaningfully better than the current standard of care – about 22% and 39% lower, respectively.
Blood pressure reductions like this would lead to a 40% reduction in stroke and 25% reduction in heart attacks. Several well published studies (New England Journal of Medicine, American Heart Association, The Journal of the American Medical Association) praise similar therapy reductions in blood pressure when assessing new therapies against placebo. This is particularly meaningful when our genotyping guided-therapy is going head-to-head against standard of care drug therapy in a very well controlled population on multiple medications. For more information, please visit https://www.clinicaltrials.gov/ct2/show/NCT03292900
What genes are analyzed?
Genes that impact your cardiac, vascular, and renal function are analyzed so that we can determine which variants you carry and can deliver recommendations for the medications that will work best for you.
Can I order tests for someone else?
Yes. This is commonly done when a loved one or relative has hypertension. They must read the disclosers and complete the the online kit activation process themselves to ensure consent.
Is Geneticure available in all US states?
At this time our test is not available to residents of New York, Maryland and Pennsylvania. Please check back periodically as we hope to be able to offer the test in these states soon.
Paying For The Test
What is your refund policy?
If our ordering physician determines that you are not a candidate for the test at this time, we will reimburse you for the cost of the test. All other returns for the test are handled by Amazon. We cannot accept returns for any kits that have been used.
What payment options does Geneticure accept?
Through Amazon we accept all major credit cards. Soon you will also be able to buy the test directly from our website.
Is it covered by insurance?
We are working on insurance coverage for the technology, but at this time Geneticure does not handle insurance billing or payments. It is most likely going to be difficult at this time for you to be reimbursed by your insurance for the cost of the test. To better understand if your policy will cover this test please contact your insurance company directly.
Can I use my health saving account to pay for the test?
Genetic Testing is generally considered eligible medical expense for FSA and HSA reimbursement. You will want to check with your carrier to confirm whether or not you can use your HSA/FSA dollars to pay for the Geneticure test.
How much does it cost?
$249 per testing kit.
Working With Your Doctor
What information is reported to my doctor?
- If your provider ordered the test, the report will be shared directly with them.
- If you ordered the test and activated it through our independent physician network, then you receive the report and your provider will not see it unless you choose to share it with them.
How will my doctor use this information provided by the test?
The recommendations are provided at the top of the report followed by a narrative description and the description of your genotypes as they relate to the functionality of medication classes.
How do I talk to my doctor about the test?
As with all medical decisions, the information is used in a conversation between you and your doctor about treatment options and what is best for you.
Security and Privacy
What is HIPAA?
HIPAA stands for Health Insurance Portability and Accountability Act. It serves 2 major functions: 1) maintains high levels of security and privacy of medical information and 2) ensures that individuals can access their own medical records and health information.
What is GINA?
GINA is the Genetic Information Non-Discrimination Act. This 2008 law prevents employers and health insurance companies from discriminating against you based on genetic results (like those in the Geneticure test). However, GINA does not protect against decisions that may be made by life insurance companies. More information on GINA can be found here: https://www.eeoc.gov/laws/types/genetic.cfm ,http://ginahelp.org/
What risks to my privacy does getting a genetic test pose?
What do you do with my DNA sample once the report is sent to my doctor?
We do not keep any samples beyond the time needed to get a Geneticure for Hypertension result report. Once a successful file is uploaded and a report is generated based on our algorithm, all DNA samples are destroyed.
What laws exist that protect my information?
The primary protection provided to customers who have had genetic testing performed is the Genetic Information Non-Discrimination Act (GINA) of 2008. This protects against discrimination, harassment, and retaliation by health insurers and employers based on your genetic results. More information can be found at: http://ginahelp.org/
Where can I find a copy of your licenses and certifications?
- Our CLIA registration for our accessioning facility is 24D2145318
- Our CLIA accreditation for sample processing and assay performance is 03D2055105