Your questions, our answers
Below are questions we often receive. We hope these answers will help. If you have more questions not addressed here, please contact us directly using our Contact Us page.
How do I order a test?
Getting the right test for you or your family member is important. All tests from Variantyx must be ordered by a licensed and approved healthcare provider in your state. Please review our downloadable Provider Discussion Guides to help start a conversation with your healthcare provider about genetic testing.
Is genetic counseling required before an order is placed?
While we always encourage genetic counseling prior to testing, some insurances require genetic counseling from a licensed and certified genetic counselor before testing is performed. Please contact our Clinical Coordination team directly if you are unsure about your insurance company’s requirements.
How do I cancel a test?
Please contact our Customer Service team directly if you would like to cancel a test. We advise patients to consult their ordering physician’s office before contacting our office to cancel a test.
How do I collect my sample?
The sample collection process depends on the type of testing your provider ordered. Detailed instructions on sample collection are included in every kit and can also be viewed on our How to Collect and Send a Sample page.
How do I return my saliva or blood kit?
The sample return process depends on the type of testing your provider ordered. Our Customer Service team provides return labels on all collection kits sent domestically and upon request for international customers. To learn about returning sample collection kits, please see our How to Collect and Send a Sample page.
How much will testing cost?
Variantyx offers insurance and institutional billing, as well as self-pay options. For patients with commercial insurance, financial assistance through our Patient Assistance Program is available to help with out-of-pocket costs when certain criteria are met. For more information on costs associated with testing, please visit our Billing page.
Will my insurance cover the test?
Most insurance plans cover some form of genetic testing based on medical need. Our Clinical Coordination team will work directly with your insurance company to determine eligibility and, if required, seek a prior authorization for testing. In the event that testing is not covered or presents a financial burden, Variantyx Clinical Coordinators will work with you to reduce the cost, where possible, through our Patient Assistance Program or through payment plans. Our goal is to ensure genetic testing is affordable and accessible to all our patients.
What happens if testing was denied by my insurance company?
Should your insurance company deny genetic testing services, our Clinical Coordination and Managed Care teams will work directly with your insurance company, the ordering provider’s office, and you (when needed) to appeal the decision.
How do I pay my bill?
If you would like to pay by credit card or direct bank transfer, please call our Customer Service team at 617-209-2090 and they will assist with processing the payment. You may also mail a check made out to “Variantyx, Inc.” to our office:
1671 Worcester Road, Suite 400
Framingham, MA 01701
What is your turnaround time for Genomic Unity® pediatric and adult testing results?
Our turnaround time for Genomic Unity® pediatric and adult testing varies depending on many factors. For more information, please contact your Customer Service team directly at 617-209-2090.
What is your turnaround time for reproductive genetics analyses results?
Our turnaround time for Genomic Unity® Prenatal Analysis is about 3-4 weeks. Our turnaround time for IriSightTM for Pregnancy Loss is about 17-24 days.
What can I expect from my results?
Tests can come back with a variety of different results or “classifications”. We suggest following up with your provider to better understand your or your child’s result. Below are a list of possible test results:
- Positive result: This is when a pathogenic or likely pathogenic variant was reported. A positive result means there was one or more variants found that are related to a person’s clinical symptoms or indicate a risk to develop a genetic disorder in the future.
- Negative result: A negative result means no variants were found that are currently related to a person’s clinical symptoms.
- Uncertain result: This is when one or more variants of uncertain significance (VUS) are reported. A VUS result means we reported one or more genetic changes in one or more genes that may be related to a person’s symptoms. However, it is not clear with the information we have today if this change is or is not related to symptoms. A VUS is not a positive or a negative result and should not be used to make medical decisions. As more genetic research is done and we learn more about genetic changes and the conditions they cause, a VUS may be reclassified to be either positive or negative.
- Indeterminate result: An indeterminate result indicates that there were relevant genetic variant(s) identified in the analysis, but that it is uncertain whether they are true variants or only appear to be true variants (artifacts). Often, a repeat test with the same style of genetic testing will lead to the results and not resolve the technical uncertainty. This means a different style of genetic testing (orthogonal confirmation) is often used to resolve the result.
- Inconclusive result: An inconclusive result means that there was an issue with the patient sample and the data cannot be interpreted. In this case, a repeat test will likely resolve the technical uncertainty. This means a repeat sample is recommended to complete the analysis and testing.
Who can help me understand what my results mean?
Your ordering provider can help you understand your results and discuss next steps. You may also seek genetic counseling services following a diagnosis. For more information on where to find support following genetic testing results, please visit our Patient Advocacy Resources page.
Can I get a copy of the report sent to me?
Yes, either your provider can send you a copy of the results or you can request a copy of the report from our Clinical Coordination team via the Contact Us page or calling us at 617-209-2090.
Does Variantyx share or sell my data?
No, we do not sell your data to other companies. We release your data only to authorized groups or people, such as your health insurance or healthcare provider. In rare instances, we may be required to release information if we receive a court order.
How do I know my results are protected?
Variantyx takes a highly ethical approach to genetic testing. To maintain patient confidentiality, test results will only be released to the ordering healthcare provider or ordering laboratory, and upon your request, to additional healthcare provider(s) indicated on the test requisition form submitted by the ordering provider. Test results will be disclosed to others only through your written consent and/or if demanded by a court of competent jurisdiction. Further information on patient confidentiality is outlined in our Patient Informed Consent form.
Am I able to get a copy of my raw data?
Yes, please contact our Customer Service team directly regarding our Raw Data Release form.
What kind of testing do you provide?
We provide diagnostic testing to analyze the baby’s DNA to determine if there is a genetic explanation for abnormal ultrasound findings or a pregnancy loss. Our testing platform uses whole genome sequencing to examine ~98% of the DNA to provide the most comprehensive information available.
How do I know if testing is right for me?
Genetic testing is offered when there is a concern for a condition in your unborn baby. Sometimes this concern is raised due to problems with growth or development seen on an ultrasound or following a pregnancy loss. Diagnostic testing is used to try to figure out if there is an identifiable cause for those problems. Unlike screening tests that may be offered during pregnancy, diagnostic tests will provide a yes or no answer (be diagnostic or non-diagnostic), rather than give information about higher or lower risk of a condition.
What are the benefits of doing diagnostic tests?
A diagnosis of a genetic disorder can have many benefits for your family and pregnancy. A diagnosis provides an explanation for the baby’s symptoms and may also provide information about the future (a prognosis). If you are currently pregnant, knowing if there is a genetic diagnosis can change the way your pregnancy is managed, lead to treatments or therapies, and connect you with other families who are experiencing a similar situation. If you have experienced a pregnancy loss, knowing if there is a genetic diagnosis can give you closure and peace of mind, help you and your healthcare provider determine if and how this loss impacts future pregnancies, and lead you to additional available technologies (such as preimplantation genetic testing) that may be able to test for that condition before or earlier in a future pregnancy.
When during pregnancy is the Genomic Unity® Prenatal Analysis ordered?
The Genomic Unity® Prenatal Analysis is typically ordered after week 15 of gestation using a sample of amniotic fluid. Your healthcare provider can explain more about an amniocentesis procedure, including the best time during your pregnancy to perform it and risks associated with the procedure.
Where can I find more information on diagnostic testing?
There are many groups that provide quality information on diagnostic tests. These include, but are not limited to:
What test options are available for individuals with a suspected genetic disorder?
We offer a variety of custom, targeted, and comprehensive analyses that diagnose genetic causes of childhood or adult disorders. We recommend you consult with your or your child’s healthcare provider to find out which test option is best. For more information on our test options, please visit our Products & Services page.
What types of samples do you accept for Rare Genetic Disorder analyses?
We accept saliva and blood samples as well as tissue samples from other labs. For more information on sample collection, please see our How to Collect and Send a Sample page.
Why are samples from biological parents requested? How does it help in my child’s testing?
We use biological samples from parents to aid in your child’s analysis. Using parent data helps us look at certain patterns of inheriting a genetic change to find which variants are most suspicious and which are least suspicious. Using parental samples gives us, and your child, the best chance to find a genetic diagnosis.
If I gave my sample for my child’s test, will I get a report, too?
No, you will not get an individual report. Biological parent samples are used only to help interpret the child’s genetic testing results.
What is the likelihood that testing with Variantyx will yield a diagnosis for me or my family member?
While whole genome sequencing has the highest diagnostic rate for any genetic test method, there are still many people who do not get a diagnosis. The likelihood of finding a genetic explanation depends on many factors. This can include the symptoms they have, the type of analysis ordered, and if the genetic cause is known today. With about 20,000 genes in the human genome, there are still many genes that are not well understood but might be found to cause a condition in the future.