Frequently Asked Questions

Frequently Asked Questions

Frequently asked questions

The basics

What Is Clarifi?
The Clarifi test is designed to provide a probability of an autism diagnosis based on epigenetic biomarkers in the saliva. 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 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 high probability 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-invasive 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 test kits can be ordered free of charge. Offer Clarifi to your patients.
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?
To ensure the integrity of the test results you can only swab a child once in a 24 hour period.
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 Clarifi cost and is it covered by insurance?

Clarifi represents a new approach to aid in the diagnosis of autism, so it’s not yet covered by insurance. To help with the cost of Clarifi in the short term, it will be offered at an introductory price of $989, a significant discount relative to other tests using next generation sequencing technology. We encourage insured patients to independently submit a claim for potential reimbursement. Families can also utilize their HSA or FSA accounts to cover the expense.

Quadrant Biosciences recognizes that laboratories do not and cannot treat patients or make medical necessity determinations as outlined by the OIG. Health care providers are to choose and notate all applicable diagnosis codes representing medical necessity.

After ordering kits online, they will be shipped directly to the ordering health care provider at no cost.

Still have questions?