Frontier Publishes Cell-El’s Research Update on ASD Biomarker Study 

Cell Ell ltd. is proud to announce the publication of our ASD Biomarkers research in Frontiers. Our work appears to be unique to ASD and can possibly serve as a basis for a blood test to confirm a diagnosis of ASD:

Autism Spectrum Disorder Diagnosis -using a New Panel of Immune- and Inflammatory-related Serum Biomarkers: A Case-Controlled Multicenter Study 

Background and objectives: Children with autism spectrum disorder (ASD) present with distinctive clinical features. No objective laboratory assay has been developed to establish a diagnosis of ASD. Considering the known immunological associations with ASD, immunological biomarkers might enable ASD diagnosis and intervention at an early age when the immature brain has the highest degree of plasticity. This work aimed to identify diagnostic biomarkers discriminating between children with ASD and typically developing (TD) children.

Methods: A multicenter, diagnostic case-control study trial was conducted in Israel and Canada between 2014 and 2021. In this trial, a single blood sample was collected from 102 children with ASD as defined in Diagnostic Statistical Manual of Mental Disorders [DSM)-IV (299.00) or DSM-V (299.00)], and from 97 typically developing control children aged 3–12 years. Samples were analyzed using a high-throughput, multiplexed ELISA array which quantifies 1,000 human immune/inflammatory-related proteins. Multiple logistic regression analysis was used to obtain a predictor from these results using 10-fold cross validation. Results: Twelve biomarkers were identified that provided an overall accuracy of 0.82 ± 0.09 (sensitivity: 0.87 ± 0.08; specificity: 0.77 ± 0.14) in diagnosing ASD with a threshold of 0.5. The resulting model had an area under the curve of 0.86 ± 0.06 (95% CI: 0.811–0.889). Of the 102 ASD children included in the study, 13% were negative for this signature. Most of the markers included in all models have been reported to be associated with ASD and/or autoimmune diseases.

Conclusion: The identified biomarkers may serve as the basis of an objective assay for early and accurate diagnosis of ASD. In addition, the markers may shed light on ASD etiology and pathogenesis. It should be noted that this was only a pilot, case control diagnostic study, with a high risk of bias. The findings should be validated in larger prospective cohorts of consecutive children suspected of ASD. Read more the full article in Frontiers…

FIGURE 2 Heatmap of raw measurements. A heatmap of Z-normalized levels of the markers selected to be included in multiple logistic regression. An intensity curve is provided for each marker (a cyan in the middle of each column). Both rows and columns were clustered with hierarchical clustering and rearranged for clarity. Procalc, procalciton; Kal-1, kallikrein-1.

Cell-El Research Take Aways

Cell-El’s research focused on a comparison between the levels of 1,000 inflammatory/ immune-related biomarkers in the blood of about 100 children diagnosed with ASD compared to 100 neuro-typically developing (TD) children. We arrived at 85% accuracy in using these biomarkers to differentiate between the ASD and TD children.

Expanding Our Research Based on these Results

This very important finding is now being used to further the development of a clinical blood test that doctors will be able to use to assess the risk for and support the diagnosis of ASD using psychological test methods. In addition, this blood test may be able to provide a diagnosis for children below the age of behavioral diagnosis. To address this possibility, Cell-El has added infants aged 10-18 months not diagnosed with ASD (Autism Spectrum Disorder) but with a sibling diagnosed with ASD (herein, high-risk infants) to our diagnostic study.

As the scope of Cell-El’s research expands, our scientists strive to understand whether this panel of biomarkers can also serve to guide treatment of ASD.  If so, then targeted interventions can be implemented. These therapies could potentially affect the immune/inflammatory issues these biomarkers indicate in the children. Cell-El has already begun researching the impact of  SCT (Stem Cell Treatment), which is one such therapy, on children diagnosed with ASD.

To find out more, read about Cell El’s Diagnostic Study in the News and to possibly join one of these study groups – please contact Leah at [email protected] or fill out the form on the Cell-El contact page