Frequently Asked Questions

Frequently Asked Questions

Frequently asked questions

The basics

What Is Clarifi?
Clarifi is an easy to administer, non-invasive, molecular test that can differentiate children with ASD from their peers with other developmental delays, as well as typically developing children. This saliva-based test provides objective support for earlier diagnosis, when treatment is most efficacious.
Why is this test important?
The current ASD diagnostic process is often slow and stressful for parents, with waiting periods to see developmental specialists up to a year or more in some areas. Clinicians need better tools to diagnose ASD at younger ages to expedite treatment services that can improve outcomes and reduce symptoms.
How does it work?
Medical researchers from Penn State and SUNY Upstate Medical University identified certain human and microbial RNAs that accurately differentiated children with autism from those with non-autistic developmental delays, as well as neurotypical children. This breakthrough finding was used to develop a sophisticated diagnostic algorithm that has become the Clarifi autism saliva test.
Is this a genetic test?
Clarifi is not a genetic test. It is the product of game-changing scientific advancements in the area of epigenetics – the factors that influence how genes are turned on and off. Our peer-reviewed, NIH funded research discovered that certain RNA molecules that regulate genetic activity and reflect interactions between a patient and their environment, were different in children with autism.
How is Clarifi administered?
Clarifi is administered in a health care provider’s office by taking a quick saliva swab.
Why is the age range 18 months through 6 years of age?
The eligible age range is currently 18 months through 6 years, i.e., until the child’s 7th birthday. This represents the age range we validated in our research, and because we have not collected sufficient data on other age groups at this time, we can’t represent that the test will be effective in children outside that range. Therefore, if the child is outside this age range at the time of testing, they are not eligible to take the Clarifi autism saliva test.
Is this a stand alone diagnosis?
Clarifi is a diagnostic aid and should be used in combination with developmental and behavioral assessments, like the MCHAT. A positive Clarifi test may give parents and clinicians more confidence to diagnosis a child with autism and start early intervention services, rather than putting them on a waiting list. It can also be used to help determine the urgency of a specialist referral.

For parents

Is my child eligible to take the test?
Clarifi is designed for children between the ages of 18 months through six years of age who have a positive MCHAT or other suspicion of developmental delay. The age limitation is based on the age range validated in our peer-reviewed research. Other contraindications may apply.
How does my child get the test?
Clarifi must be prescribed by a healthcare professional. Set up an appointment with your family physician to receive the test. If you’re not sure they offer the test yet, print out this informational sheet (PDF) and bring to your child’s healthcare provider so they can order the test for you. The test itself is administered via a non-invasion saliva swab by your healthcare provider.
Can I be present when my child is tested?
Of course. The saliva swab takes seconds to administer and can be done while the parent or guardian is in the room.
What will this test look like at my doctor’s office?
Where can I get this test?
Clarifi is available in every state except New York. If you want to bring Clarifi to a doctor office near you, visit the Get Clarifi page for more instructions.
How long does it take to get results?
Once the test has been administered and the patient has registered online, the sample sent to our lab, results will be sent to the healthcare provider within 3 to 6 weeks.

For health care providers

How do I get Clarifi in my organization?
Clarifi kits can be requested free of charge when they are available. Subscribe to be notified when test is available in your area.
Where should I store my test kits?
Clarifi kits can be easily stored in your office at room temperature.
What areas of the mouth should I swab?
The lower right and left side of the mouth between the teeth and gums and under the tongue.
How many times can I swab a child?
Only once in a 24 hour period. You can NOT swab the child more than once a day to ensure integrity of test results. If needed, wait at least 24 hours to administer a replacement swab.
Why do I have to wait 24 hours to reswab?
See above.
Is this a stand alone diagnosis?
Clarifi provides an early measurement of epigenetic changes associated with ASD and should be used in combination with developmental and behavioral assessments. There is currently no definitive diagnostic test for ASD. Clarifi results should be interpreted by the ordering physician in the context of the child’s personal medical history. Clarifi may expedite the diagnostic process and provide clinicians and parents with more confidence in the diagnosis.
What are the contraindications?
Click here for list of contraindications. Clarifi should not be used with patients who have any of the following conditions at the time of testing.
How long does it take to get results?
Once the test has been administered and the patient has registered online, the sample sent to our lab, results will be sent to the healthcare provider within 3 to 6 weeks.

Cost & insurance

How much does this cost?
Clarifi represents a new approach to aid the diagnosis of autism, so its not yet covered by insurance. To help with the cost of Clarifi in the short term, while we work to secure insurance coverage, it will be offered at a special introductory price of $989. Clarifi is covered by Health Savings Accounts (HSA’s).
Does insurance cover the test?
At this time, insurance will not cover the test. However it is covered by most Health Savings Accounts (HSAs). We are currently taking action to try and change that in the future.

Still have questions?