Iliad Neurosciences Inc.
Iliad Neurosciences Inc. (Iliad) is a dynamic life sciences company that develops products for the diagnosis and treatment ("theranostic") of neuro-development disorders with an emphasis on autism and related conditions. Iliad has licensed a late stage patented diagnostic technology related to Folate Receptor A Autoantibodies (FRA-Ab).
The Folate Receptor Antibody Test (FRAT®) is a laboratory test with two components. FRAT identifies an important metabolic deficiency in pregnant women whose fetuses have neural tube defects (NTD), infants with cerebral folate deficiency (CFD) and children with autism spectrum disorders (ASD).
From the current evidence, it appears that FRA-Ab testing can lead to treatment that may improve the lives of children with ASD. As FRA-Abs appear to be highly prevalent in children with ASD, we recommend that FRA-Ab testing should be considered in all patients with ASD.”
If antibodies to the Folate receptor are present, then there is an indication that Folate is not being properly distributed across the blood brain barrier, or into other important tissues such as the placenta and ovaries. In these instances, Folate is either being “blocked” or “binded” by these antibodies, ultimately impeding its proper delivery.— R E Frye et al., Cerebral folate receptor autoantibodies in autism spectrum disorder Molecular Psychiatry (2013) 18, 369–381; doi:10.1038/mp.2011.175; published online 10 January 2012
The Importance Of FRA-Ab Testing
Iliad's FRAT® assesses the ability of folate (folic acid) to enter the brain. Folate, a vitamin, is essential for normal function of many tissues. FRAT® measures the presence of antibodies that interact, either block or bind, with the activity of the Folate Receptor A (FRA). Click here for more information
How To Test?
Frequently Asked Questions
What Does FRAT® Mean, Exactly?
FRAT® is an acronym for Folate Receptor Antibody Test. This test (which is a blood test) measures the presence of antibodies to the Folate receptor. The Folate receptor is responsible for transporting Folate into various tissues such as the brain, placenta and ovaries. Folate, a vitamin B9, is critical for proper human growth and development. It is also necessary for maintaining a healthy nervous system throughout – contributing to normal nerve maintenance and proper brain function. Unhindered delivery of Folate to the brain is essential for a healthy, functioning brain.
If antibodies to the Folate receptor are present, then there is an indication that Folate is not being properly distributed across the blood brain barrier, or into other important tissues such as the placenta and ovaries. In these instances, Folate is either being “blocked” or “binded” by these antibodies, ultimately impeding its proper delivery.
What Is Difference Between Blocking And Binding Assays In FRAT®?
FRAT® consists of 2 parts – a blocking assay and a binding assay. “Assay” is the technical laboratory term for a quantitative test of a substance. In other words, the FRAT® “assays” quantify the amount of blocking antibodies and binding antibodies present. Both types of antibodies inhibit the transport of Folate to tissues such as the brain. Blocking antibodies directly block the access of Folate to the receptor, while binding antibodies are thought to affect the general position of the receptor so that Folate can't get through it and into the tissue properly. Indirectly, the assays inform us about the availability of Folate (and its active form called 5-MTHF) in these tissues.
Why Do I Need Both Assays?
Some children with ASD or CFD or related disorders can have either one of these antibodies (blocking or binding) or both. We screen for both categories of antibodies to ensure that no positive samples are missed.
How Long Do The Assays Take?
The assays are not simple to do and the performance of each assay takes two or three days, because of the need for overnight incubations. Turn-around time is generally 6 to 10 business days.
How Reliable Are The Assays?
We have a series of checks and balances in place to ensure that all steps in the assay are carried out correctly. Each assay has to be validated using strict criteria. We strive to reduce variability and maintain consistency from one assay to the next. Sometimes an assay needs to be repeated because the result is equivocal or borderline, for reasons not always known.
Are The Levels Of Antibodies Stable Over Time?
Antibodies tend to fluctuate over time. The causes are not always known. In some cases the increased intake of cow's milk elevates the levels of the antibodies and removal of milk from diet tends to lower the levels in some children.
Do I Need To Fast Prior To Sending In A Sample?
No, fasting is NOT necessary. If you are taking Folinic Acid or 5-MTHF supplements please withdraw from these supplements for a period of 48 hours prior to blood draw.
Are There Any Diet Restrictions To Follow Prior To Submitting A Sample?
Yes. If you are taking Folinic Acid or 5-MTHF supplements, please withdraw from these supplements for a period of 48 hours prior to blood draw. Sometimes, these supplements may affect the quantitative results of FRAT® if they are still in the system.
What Happens If The Blood Is Not Kept Frozen Or In The Refrigerator Before The Assays?
As a general principle, any prolonged removal of samples from refrigeration can damage the antibodies and lead to reductions in their levels. However, the antibodies should be stable for 1-2 days at room temperature.
Do Children With Other Disorders Like ADHD, Schizophrenia And Depression, Also Have These Antibodies?
There are no large, systematic studies in such children, but a number of publications indicate that some patients with these disorders also have these antibodies. Further, larger studies are needed.
Can A Healthy Person Have These Antibodies Too?
The incidence of antibodies in children without neurological disorders is about 2-3%, and in the population at large it tends to increase with age, reaching 10-15% after age of 65.
Do Family Members Of Children With ASD Have These Antibodies Too?
According to published studies some 20-30% of mothers or fathers of children with ASD have these antibodies.
Do Insurance Companies Reimburse The Cost Of These Tests?
At this time, the tests are not reimbursed by insurance companies. We are working, however, to have these tests covered.
What Is The Cost Of FRAT®?
There is NO cost for the FRAT® kit. We send that to you free of charge.
Please note that the patient is responsible for the cost of sending the sample to our laboratory. We do this so that you have the flexibility of choosing your own shipping carrier (i.e Federal Express, UPS, USPS etc.).
How Do I Send In A Sample?
Is FRAT® performed in a CLIA certified lab?
Yes, FRAT® is performed in a CLIA certified lab. The CLIA # is 39D2109943. A copy of the certificate is available by clickingHere
Boas Gonen, MDPresident/CEO
Steven Adelman, PhD, FAHAChief Scientific Officer
Steve TsetsekosChief Financial Officer
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