FAQs

What is the NPDX AA test?

The NPDX AA test is a blood of children with certain differences in metabolism and compares them to specific metabolic imbalances that are associated with autism spectrum disorder (ASD). When one or more of these imbalances is detected, there is an increased chance the child will receive an ASD diagnosis.

The NPDX AA test will include a positive or negative result compared to data from the CAMP study as well as metabolic information regarding the specific differences between your child’s metabolism and others. Your child’s doctor may use this information to determine the best treatment options, based on the child’s own metabolism.

The NPDX AA test can identify a subset of children with autism spectrum disorder (about 30%) who have a metabolic imbalance that is associated with autism spectrum disorder.

Who should get this test?

A child who exhibits delayed development that could be associated with autism spectrum disorder (ASD). The NPDX AA test is one tool that physicians and clinicians can use as a first check for diagnosis and referral.

The test is appropriate for a child who:

  • Has failed screening for developmental milestones indicating risk for ASD (e.g. M-CHAT*, ASQ-3, PEDS, STAT, etc.)
  • Has a family history such as a sibling diagnosed with ASD
  • Has an ASD diagnosis for whom additional metabolic information may provide insight into the child’s condition and therapy.

The test panel can also be useful for families on a waiting list to see a specialist. If a child receives a positive result on the NPDX AA test, therapeutic interventions could begin before a formal autism diagnosis is conferred by a neurodevelopmental specialist.

*Ask your pediatrician about taking the M-CHAT.

Please note: The clinical study used to validate this test was performed using fasting, blood plasma samples from patients 18-48 months old. Test performance has not been evaluated in patients younger than 18 months or older than 48 months of age.

Why use the NPDX AA test?

  • Research shows that the earlier a child receives an ASD diagnosis, the better. Treatment can begin sooner, leading to better outcomes for the child. NeuroPointDX’s test has been developed for children as young as 18 months of age.
  • NeuroPointDX’s NPDX AA test is an additional tool that parents and physicians can use to reach a diagnosis sooner. The test can be used in combination with genetic tests and evaluation for disorders like Fragile X or Attention Deficit Disorder that can be associated with an increased rate of ASD diagnosis to build a more complete picture of the child’s autism profile and how it should be treated.
  • The NPDX AA test provides an objective, biological endpoint to support diagnosis and more precise treatment.

Is theNPDX AA test available in every state?

The NPDX AA test is available in 45 states; we are actively working toward approval in the others. Currently, we cannot accept blood plasma samples from California, Maryland, New York, Pennsylvania, and Rhode Island.

How do I get the NPDX AA test for my child?

The NPDX AA test must be ordered by a physician, but you can suggest ordering it at an appointment with your child’s physician or clinician.

Need help talking to the doctor or clinician? Read and download our guide!

How do I prepare my child for the test?

The NPDX AA test requires a fasting blood draw. Make sure your child has not had anything to eat or drink except water for at least 12 hours prior to the blood draw. If your child has not fasted, NeuroPointDX will not be able to accurately process the sample.

We suggest these tips:

  • Schedule a blood draw first thing in the morning, before breakfast.
  • Bring the child’s favorite snack or treat to eat as soon as the blood draw is completed.
  • Allow the child to participate in a chosen activity after the blood draw.

Learn more about test preparation.

What if the physician or clinician suggests that we “wait and see” for 6-12+ months to see if my child catches up to peers?

Children develop skills like walking and talking at different times, so some physicians or clinicians may suggest a “wait and see” approach when a child shows delays.

Why this approach isn’t the best choice for your child:

  • An earlier diagnosis and treatment is important for a child’s short- and long-term development.
  • “Wait and see” can be frustrating for parents. It’s tough to wait it out when your child needs help. The NPDX AA test offers an opportunity to identify and refer children at risk of an ASD diagnosis earlier so they can receive treatment sooner.

NeuroPointDX’s metabolic test is an alternative to “wait and see.” If the test comes back positive, a physician or clinician should make the referral to a neurodevelopmental specialist with sound scientific support, based on clinical study that further testing could benefit the child—and should be performed sooner than later.

When will test results be available?

Test results will be available within two weeks of NeuroPointDX’s receipt of both the blood plasma sample and full payment. We will fax the report to your doctor when results are ready.

What does it mean if my child gets a positive result on the test?

If your child receives a POSITIVE result on the test, it means that he or she has a metabolic imbalance that indicates an increased risk of autism spectrum disorder (ASD) diagnosis.

What do I do if my child gets a positive result on the test?

Work with your child’s doctor to determine next steps. Some possibilities include:

  • Work with your child’s physician or clinician to obtain a behavioral ASD diagnosis from a specialist. A positive result on the NPDX AA test could also justify beginning treatment before a behavioral diagnosis is obtained. Multiple studies have shown that earlier diagnosis can mean better outcomes for children with ASD.1-3
  • Schedule other testing, as suggested by the doctor, depending on the specific symptoms and needs of your child.
  • Seek out resources in the larger autism community to help yourself and your child learn more. Understand that you are not alone. There are resources available to improve outcomes for your chihld and the NPDX AA test is the first test to both identify children earlier and offer insight into more precise treatment.

What does it mean if my child gets a negative result on the test?

If your child receives a NEGATIVE result on the test, it means that he or she does not have a metabolic imbalance in the currently available NPDX AA panel that NeuroPointDX has identified as being indicative of autism spectrum disorder in its clinical study, CAMP. A negative result does not mean that the child won’t be diagnosed with ASD.

NeuroPointDX’s NPDX AA test can identify about 30% of children with ASD, which means that about 70% of those with autism spectrum disorder will receive a negative result on this test. NeuroPointDX is already working on validating its next panel through its clinical study, CAMP, thereby increasing the percentage of children it can identify as being at risk of ASD.

How will I receive the results?

Your child’s doctor will receive the test results when they are ready. Test results will be available within two weeks of NeuroPointDX’s receipt of both the blood plasma sample and full payment. To get a copy for your records, contact us to request a form and additional information about our policy.

What do I do if I have questions about the results report?

Talk to your child’s doctor to understand the results report.

How do I contact NeuroPointDX?

There are several ways to reach out to NeuroPointDX with questions:

Mail

NeuroPointDX
c/o Stemina Biomarker Discovery
504 S Rosa Rd, Ste 150
Madison, WI 53719

Phone: 608-441-8187 or 833-434-6965 (toll-free)

Fax: 608-646-7739

Email: customercare@neuropointdx.com

Web form

Why does NeuroPointDX use metabolism, not genetics, to identify children with a high risk of being diagnosed with autism?

Autism spectrum disorder (ASD) is complex. The presence and severity of symptoms vary widely from one individual to the next. Given ASD’s complexity, it’s not surprising that no single cause has been identified. Current research indicates that genetic, biological, and environmental factors may all play a role in causing ASD. Even when autism spectrum disorder appears to be caused by genetics (a child has a parent with ASD, for example), there may be several different genes involved. The exact genes and the complex interactions between them are not fully understood.

NeuroPointDX uses the science of metabolomics to identify people with ASD. Metabolomics can make this identification, regardless of what causes autism (or that particular child’s autism). Through our extensive clinical study, the Children’s Autism Metabolome Project (CAMP), we identified several metabolic signatures linked to ASD. These metabolic signatures show that certain amines are out of balance with one another.

NeuroPointDX can identify a subset of children who are likely to receive an ASD diagnosis based on their metabolic signature. By measuring the levels of certain amines and comparing them to each other, we can provide an objective, biological indication of ASD. Read our Metabolomics 101 page for more information.

How is the NPDX AA test different from amino acid tests?

Our metabolic test measures amine levels, so you may wonder if a basic amino acid test is sufficient. An amino acid test does provide some information, but it doesn’t tell the whole story.

The NeuroPointDX team has developed algorithms with very precise thresholds set based on clinical data from the CAMP study that evaluate the amines in relation to one another, resulting in identification of a metabolic imbalance. Levels of individual amino acids provided in the standard range delivered by major diagnostic companies are not capable of identifying a higher risk of ASD. They lack the clinical study data and precision provided by NeuroPointDX through the CAMP study. This information is only available in the NPDX AA panel provided by NeuroPointDX.

Is the NPDX AA test covered by insurance?

Our test is not covered by insurance yet. Keep an eye on the website and NeuroPointDX’s social media accounts for insurance coverage announcements. However, the test is eligible for reimbursement through flexible savings accounts (FSA).

How much does the NPDX AA test cost?

The list price for the NPDX AA test is $1,000. There is a 25% discount for self-pay ($750); other discounts, including needs-based financial assistance, are also available. Contact customer care at 833-434-6965 (toll-free) or 608-441-8187 for more information.

What types of payment do you accept?

We accept check (made out to NeuroPointDX), credit card (Visa, Mastercard, Discover, American Express), and PayPal. Sign up for a NeuroPointDX account to learn more. You may use your health flexible savings account (FSA) to pay for the test.

Can I pay for the test in installments?

Yes, you can pay in installments. Read the Billing Policy or contact customer care for complete details.

Is financial assistance available?

Yes, we do offer needs-based financial assistance. Read the Billing Policy or contact customer care for complete details.

Are there special instructions for sample preparation and shipping?

Yes, the instructions for preparing and shipping the blood plasma sample are very important. We outline the main points here on the website. The health care professional who draws your child’s blood will need the complete instructions—you can find them here. The blood sample must be shipped overnight on dry ice.

Where do I ship a sample?

Your health care professional should ship the blood plasma sample—overnight and on dry ice—to:

NeuroPointDX CLIA Lab
c/o Stemina Biomarker Discovery
504 S Rosa Rd, Ste 150
Madison, WI 53719

Does NeuroPointDX pay for shipping?

Shipping costs are included in the price of the test. Your doctor’s office does not have to pay to ship the sample to NeuroPointDX.

The lab can contact us at 833-434-6965 (toll-free) or 608-441-8187 to arrange for shipment or delivery by a medical courier to NeuroPointDX’s headquarters in Madison, Wisconsin.

What is the NPDX AA test?

How can I get this test now?

Learn how to talk to your doctor about the NeuroPointDX blood panel.

References

  1. Fernell, Elisabeth, et al: Early diagnosis of autism and impact on prognosis: a narrative review. Clinical Epidemiology. 2013; 5: 33-43.
  2. Rogers, Sally et al: Evidence-based comprehensive treatments for early autism. Journal of Clinical Child & Adolescent Psychology. 2008; 8-38.
    1. Corsello, Christina: Early intervention in autism. Infants & Young Children. 2005: 18: 74-85.