Dedicated to helping families affected by autism
Dedicated to helping families affected by autism
Autism (AU) and Autism spectrum disorders (ASDs) are a group of neurodevelopmental disorders characterized by impaired social interaction, decreased verbal and non-verbal communication capabilities, and stereotypical repetitive behavior patterns.
In general, the symptoms are present within the first two to five years of life and persist
Autism (AU) and Autism spectrum disorders (ASDs) are a group of neurodevelopmental disorders characterized by impaired social interaction, decreased verbal and non-verbal communication capabilities, and stereotypical repetitive behavior patterns.
In general, the symptoms are present within the first two to five years of life and persist into adulthood. While the severity of the symptoms varies widely among affected individuals, in most instances these disorders can lead to severe cognitive, communicative and social disabilities, and can be devastating to those children afflicted with autism and to their families.
A variety of factors have been implicated in the etiology of autism, including both genetic and environmental factors. Given the fact that ASDs are highly heterogeneous and the degree of severity varies considerably among those afflicted, it is highly likely that there are multiple causes of the disorder. There is a need for better diag
A variety of factors have been implicated in the etiology of autism, including both genetic and environmental factors. Given the fact that ASDs are highly heterogeneous and the degree of severity varies considerably among those afflicted, it is highly likely that there are multiple causes of the disorder. There is a need for better diagnostic and prognostic tests that can identify children with autism at an earlier age, such as: 1) tests to identify subgroups among those children, 2) tests to identify children at risk for developing autism and 3) tests for identifying adults who are at risk for having children with autism.
During the last decade, a dramatic rise in the incidence of autism in the western world has been observed. The recent estimates in the United States from the Centers for Disease Control (CDC) estimates that 1 in 59 children are currently diagnosed with ASD. The overall diagnosis of ASD is more than diabetes, Down’s syndrome, and cancer
During the last decade, a dramatic rise in the incidence of autism in the western world has been observed. The recent estimates in the United States from the Centers for Disease Control (CDC) estimates that 1 in 59 children are currently diagnosed with ASD. The overall diagnosis of ASD is more than diabetes, Down’s syndrome, and cancer combined. Although part of this increase can be attributed to increased awareness of the disorder among pediatricians, other studies have indicated that the increase in the incidence cannot be completely attributed to increased diagnosis. It is clear that there are unidentified factors that contribute to the dramatic increase of the disease.
The immune system is charged with identifying and destroying unwanted assailants. It is made up of a complex network of specialized cells and molecules that patrol the body seeking out intruders. In order to defend us, the immune system must be able to distinguish between self-tissues and foreign invaders. In healthy individuals, the im
The immune system is charged with identifying and destroying unwanted assailants. It is made up of a complex network of specialized cells and molecules that patrol the body seeking out intruders. In order to defend us, the immune system must be able to distinguish between self-tissues and foreign invaders. In healthy individuals, the immune system will mount responses to unfamiliar objects only, and ignore the body itself.
Sometimes this identification system breaks down, and the immune system mistakenly targets the body’s own tissues. This phenomenon is known as autoimmunity, and is observed in diseases like lupus, rheumatoid arthritis, myasthenia gravis, and multiple sclerosis.
A major weapon used by the immune system to protect the body is group of proteins called antibodies. Produced by highly specialized white blood cells, antibodies work by flagging unwanted invaders for destruction and removal.
In autoimmune disorders, antibodies are directed against various building blocks of the body like DNA or neurons. Self-directed antibodies are called ‘autoantibodies’, and are a major contributor to the destruction observed in autoimmune disorders.
During pregnancy, antibodies are passed from the mother to the developing fetus. These antibodies have a protective role, serving as a temporary immune system until the child’s own system matures during the first year of life.
If autoantibodies are present in maternal circulation, the fetus will receive them as well. Autoantibodies pass
During pregnancy, antibodies are passed from the mother to the developing fetus. These antibodies have a protective role, serving as a temporary immune system until the child’s own system matures during the first year of life.
If autoantibodies are present in maternal circulation, the fetus will receive them as well. Autoantibodies passed from the mother are capable of reacting with important proteins in the body of the developing fetus. In some autoimmune disorders, including lupus, rheumatoid arthritis, myasthenia gravis and Grave's disease, autoantibodies produced by the mother can have a negative effect on the developing fetus.
This is the first biology-based, actionable, analytically validated autism risk-assessment test for decision making, with transitioning from a University laboratory test to a commercially available clinical CLIA test, for use by parents and clinicians.
If a woman has a negative MARA test, she has a 43% reduced risk of having a child w
This is the first biology-based, actionable, analytically validated autism risk-assessment test for decision making, with transitioning from a University laboratory test to a commercially available clinical CLIA test, for use by parents and clinicians.
If a woman has a negative MARA test, she has a 43% reduced risk of having a child with autism - no other technology can offer this.
USES
1. MISSED DEVELOPMENTAL MILESTONES
The initial market for the MARA test will be women who are seeking a diagnosis for a child that has missed some early developmental milestones or otherwise has some developmental disabilities.
Approximately 6.99% of children in the United States, or over 5 million, have a been diagnosed with a developmental disability (23). In 2019, Zablotsky, et al reported a prevalence of 16.93-20% or 3.5-4.2 M of the 21M children in the US had some type of developmental delay. In his report, he found an ASD prevalence of between 1.74-2%, or 365,000 - 420,000 ASD children in the US.
The American Academy of Pediatrics recommends that pediatricians screen for ASD if there are concerns about the child’s development routinely at the 9-, 18-, and 30-month well-child visits. One of the most common screening tools to identify possible cases of autism in children is the Modified Checklist for Autism in Toddlers™ (M-CHAT). When the M-CHAT is used in well-child visits between16 and 30 months, approximately 5.7 percent of children will screen positive .
With over 21 million children under the age of five in the United States, identification of 1 to 5.7 percent would indicate that between 210,000 and 1.2 million (avg. 705,000) require additional screening to determine whether they have an ASD. The mothers of these children identified by M-CHAT or other screening tools would represent MARABio’s initial target market. An initial conservative number with a 30% referral of an average 705,000 might place those who would most benefit from the MARA test at ~211,000.
With the currently used standard behavioral assessment tests, an accurate ASD diagnosis is often not made until ages 3-4.5 yrs., well past the time when early intervention might be most valuable. With more children today being diagnosed with ASD than diabetes, Down’s syndrome, and cancer combined. Studies have shown that with early intensive behavioral intervention (EIBI) starting by age 2 or 3, up to 60% of these children will be able to attend mainstream schools.
It is reasonable to expect that even earlier intervention would provide the most favorable outcomes.
2. PRIOR ASD CHILD
The second target population for the MARA test will be women who have already given birth to an autistic child.
There are 73.7M children in the USA under 18. The CDC estimates that 1 in 54 may have an ASD diagnosis, or roughly 136,000 children who have been diagnosed with an ASD each year whose mothers would represent a critical target market for MARABio. A recent reported that approximately 43% of parents favor having another child after a previous child was diagnosed with ASD.
The CDC reported this target population, or roughly half of the 136,000 or 68,000/yr. (or 272,00 for 4 years), is expected to be highly motivated to seek preconception testing. A conservative estimate for those desiring tests would be might be 40% or 109,000.
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