Frequently Asked Questions

Frequently Asked Questions

Frequently asked questions

The basics

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.
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.
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.
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.
Clarifi is administered in a health care provider’s office by taking a quick saliva swab.
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.
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.
Clarifi is being offered initially as a laboratory testing service, which is regulated as a Laboratory Developed Test (LDT) under the CLIA regulations. The FDA presently does not regulate LDTs, and therefore Clarifi has not been cleared or approved by the FDA.

For parents

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.
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.
Of course. The saliva swab takes seconds to administer and can be done while the parent or guardian is in the room.
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.
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

Clarifi kits can be requested free of charge for your practice by visiting Clarifiasd.com and creating an account.
Clarifi kits can be easily stored in your office at room temperature.
The lower right and left side of the mouth between the teeth and gums and under the tongue.
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.

Cost & insurance

Clarifi represents a new approach to aid the diagnosis of autism, so it may not be covered by your health plan, as of yet. Clarifi may be covered by Health Savings Accounts (HSA's) and Flexible Savings Accounts (FSA’s).
Clarifi represents a new approach to aid the diagnosis of autism, so it may not be covered by your health plan, as of yet. Clarifi may be covered by Health Savings Accounts (HSA's) and Flexible Savings Accounts (FSA’s). Clarifi's initial introduction into the commercial market is offered at a temporary discounted, only direct-to-patient, price of $989 as we gather additional data to refine the Clarifi customer experience.

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