The disclosure relates to methods of preparation of fetal nucleated red blood cells (NRBCs) from biological samples for diagnostic testing.

The disclosure provides for pathogenic biomarkers and serum extracellular vesicular biomarkers that are associated with vascular anomalies and malformation of endothelial cells, and uses thereof, including for diagnosis, prognosis and therapy.

In certain embodiments, the invention stems from the discovery that analysis of population distribution curves of metabolite levels in blood can be used to facilitate predicting risk of autism spectrum disorder (ASD) and/or to differentiate between ASD and non-ASD developmental delay (DD) in a subject. In certain aspects, information from assessment of the presence, absence, and/or direction (upper or lower) of a tail effect in a metabolite distribution curve is utilized to predict risk of ASD and/or to differentiate between ASD and DD.

The disclosure provides for pathogenic biomarkers and serum extracellular vesicular biomarkers that are associated with vascular anomalies and malformation of endothelial cells, and uses thereof, including for diagnosis, prognosis and therapy.

The invention relates to allergic disease, to the development of allergic disease in infants, to determining the likelihood of development of allergic disease in infants and to minimizing the likelihood of development of allergic disease in infants.

An application of a composition in preparation of a drug for diagnosing infantile hemangioma (IH) and/or monitoring progress and prognosis thereof, and a test kit including the composition and instructions. The composition includes at least one of the following four groups of substances: (1) at least one of a total fatty acid or a total saturated fatty acid or a total mono-unsaturated fatty acid or a specific fatty acid; (2) at least one of specific metabolites; (3) at least one of specific proteins; and (4) at least one of specific lipid subclass substances or lipid molecules. The application and the kit can realize early warning/prediction and early diagnosis of the IH, close monitoring of disease progress, objective evaluation of a treatment effect of the drug, and accurate reflection of prognosis.

The invention relates to biomarkers in children's skin, in particular in the skin of infants, the expression of which changes when the skin is affected by atopic dermatitis. Such markers are particularly advantageous in that they allow the skin's response to atopic dermatitis to be monitored. The inventors have developed methods for evaluating the in vitro efficacy of formulations in preventing the effects of atopic dermatitis on a child's skin, using a skin model specifically capable of reproducing the characteristics of children's skin.

Disclosed are infant formulas and corresponding methods of using them to promote retinal health and vision development in infants. The formulas, which are free of egg phospholipids and comprise fat, protein, carbohydrate, vitamins, and minerals, including docosahexaenoic acid and, on a ready-to-feed basis, at least about 50 mcg/liter of lutein, wherein the weight ratio of lutein (mcg) to docosahexaenoic acid (mg) is from about 1:2 to about 10:1. The formulas are also believed to be especially useful in reducing the risk of retinopathy of prematurity in preterm infants.

The present invention is related to the in vitro use of lyso-Gb1 as a draggable target in the development of a drug, and to antagonist of lyso-Gb1 for use in the treatment and/or prevention of a disease, wherein the disease is Gaucher disease or Parkinson's disease.

The present invention provides a panel of at least five clinical analyses or tests (using serum samples) to determine the risk of pediatric acute-onset neuropsychiatric syndrome (PANS) and/or pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) in an individual. These include enzyme linked immunosorbent assays (ELISAs) to measure antibody titers against neuronal antigens present in the brain; the neuronal antigens include lysoganglioside, tubulin, dopamine receptor D1, dopamine receptor D2, serotonin receptor 5HT2A, and serotonin receptor 5HT2C. Antibody titers against at least four of these neuronal antigens are required in the present methods; preferably antibody titers against all of these neuronal antigens are measured. A final assay is used to quantify calcium/calmodulin-dependent protein kinase activity using a neuronal cell line. The results of these analyses or tests are then combined using an algorithm to determine whether a PANS or PANDAS diagnosis is appropriate for the individual. Depending on the diagnosis, an appropriate treatment can be determined.