Frequently Asked Questions

Frequently Asked Questions

Frequently asked questions

The basics

What Is Clarifi ASD?
The Clarifi autism saliva 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 often includes waiting periods for a final diagnosis up to a year or more in some areas. Clarifi ASD can help identify children with autism at younger ages in order to expedite access to important intervention services.
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 other developmental delays, as well as typically developing 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 ASD is not a genetic test. It is the product of scientific advancements in the area of epigenetics – the factors that influence how genes are turned on and off. Epigenetics is the study of changes in gene function that do not include changes to the genetic sequence.  In very simple terms, genetics is the study of our underlying genes (DNA), while epigenetics is the study of how our genes express themselves (RNA).
How is Clarifi ASD administered?
Clarifi ASD 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 ASD is a diagnostic aid intended to be administered to patients or children who screen positive on an autism screening tool (e.g., M-CHAT). The results should be used in combination with developmental and behavioral assessments when considering an autism diagnosis.
Is this test FDA approved?
Because Clarifi ASD is a laboratory developed test, the process of certification is different from products that need to be approved by the FDA.  There are two divisions within the Department of Health and Human Services (HHS) that regulate molecular tests: the Centers for Medicare and Medicaid Services (SMS) and the FDA.  CMS regulates CLIA laboratories and is, therefore, the approving body for Clarifi ASD.
All Clarifi ASD samples are processed at a CLIA (Clinical Laboratory Improvement Amendments) certified and CAP (College of American Pathologists) accredited lab (Admera Health).
Why is Clarifi ASD not available in New York?
All clinical laboratories in the US have federal regulatory oversight by CMS (Centers for Medicare and Medicaid Services) and must adhere to the strict federal guidelines promulgated under the Clinical Laboratory Improvement Amendments (CLIA). Clarifi ASD was developed in a CLIA certified and College of American Pathologists (CAP) accredited laboratory and received specific CLIA approval in November 2019.  All states except NY adhere to these federal guidelines; New York has a similar but separate process managed by the NYS Department of Health.  We are working diligently to achieve clearance in New York and do not expect any issues other than timing.

For parents

Is my child eligible to take the test?
Any child 18 months through 6 years with a positive screening test (e.g., M-CHAT) or underlying concern for autism is a candidate for Clarifi ASD.
How does my child get the test?
Clarifi ASD must be prescribed by a health care provider. 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 health care provider so they can order the test for you. The test itself is administered via a non-invasive saliva swab by your health care 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 ASD is available in every state except New York. If you want to bring Clarifi ASD to a doctor’s 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, the patient has registered the test online and the sample has been sent to our lab, results will be sent to the health care provider within 3 to 6 weeks.
Where do Clarifi ASD results go?
Clarifi ASD results can be viewed by the ordering health care provider in the portal when available. The Clarifi ASD report is meant to be reviewed at a follow-up appointment with the patient’s family. A personalized access code on the Clarifi ASD report will allow the family to download a copy of the report after the follow-up appointment.
Is this a stand alone diagnosis?
Clarifi ASD is a diagnostic aid intended to be administered to patients or children who screen positive on an autism screening tool (e.g., M-CHAT). The results of Clarifi ASD should be used in combination with developmental and behavioral assessments when considering an autism diagnosis.

For health care providers

Does Clarifi ASD need to be ordered by a practicing HCP?
This is a prescription only test and must be ordered by a health care provider with a valid NPI number.
Which patients can benefit from Clarifi ASD?
Any child 18 months through 6 years with a positive screening test (e.g., M-CHAT) or underlying concern for autism is a candidate for Clarifi ASD.
Is this a stand alone diagnosis?
Clarifi ASD is a diagnostic aid intended to be administered to patients or children who screen positive on an autism screening tool (e.g., M-CHAT). The results of Clarifi ASD should be used in combination with developmental and behavioral assessments when considering an autism diagnosis.
How do I order Clarifi ASD?
Clarifi ASD kits can be ordered free of charge by a health care provider. Visit account.clarifiasd.com/clinicians/new to complete an application for your practice (you can request test kits at this time). Once this has been submitted you will receive a verification email, click “Verify email address” to complete your account set up and order. 
I want more information, who can I speak with?
Call our Clarifi ASD team at 866-205-7336 or contact us by email at [email protected]
What happens after I administer the Clarifi ASD test?
Once the Clarifi ASD test has been administered at an office appointment, the patients’ family will need to create an account, register and pay for the test.  A patient instruction card is provided inside the test kit.
Where do Clarifi ASD results go?
Clarifi ASD results will be sent to the ordering health care provider when available. The report is meant to be reviewed at a follow-up appointment with the patient’s family. A personalized access code on the Clarifi ASD report will allow the family to download a copy of the report after the follow-up appointment.
How long does it take to get results?
Once the test has been administered, the patient has registered online and the sample sent to our lab, results will be sent to the health care provider within 3 to 6 weeks.
What are the contraindications?
Click here for list of contraindications. Clarifi ASD should not be used with patients who have any of the listed conditions at the time of testing.
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.
Where should I store my test kits?
Clarifi ASD kits can be easily stored in your office at room temperature.

Cost & insurance

How much does Clarifi ASD cost and is it covered by insurance?

Clarifi ASD 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 ASD 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 Office of Inspector General (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?