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Clinical Test for Autism in Children based on Plasma and Urinary Biomarkers
Using samples from 69 children (38 had been diagnosed with ASD), it was found that wehn compared to healthy controls, those children with ASD had increased advanced glycation endproducts (AGEs), Nε-carboxymethyl-lysine (CML) and Nω-carboxymethylarginine (CMA), and increased oxidation damage marker, dityrosine (DT), in plasma protein.
It was also found that children with ASD had increased CMA free adduct in plasma ultrafiltrate and increased urinary secretion of oxidation free adducts, alpha-aminoadipic semialdehyde and glutamic semialdehyde. Children with ASD also had decreased fractional excretion of arginie and CMA with respect to healthy controls.
Comparing the children with ASD with the healthy controls, the following strong differentiating features were established: plasma proteins AGEs - CML, CMA, and 3-deoxyglucosone-derived hydroimidazolone, and oxidative damage marker, DT.
These strong differentiating features have been used as the basis for a clinical test (from plasma and urinary samples). Results of this test produced sensitivity, specificity and receiver operating characteristic area-under-the-cureve of 92%, 84% and 0.94, respectively.
Testing for these specific biomarkers therefore offer the exciting possibility of a clinical test to detect ASD in children.
Research has shown that early diagnosis of ASD, along with early intervention, can improve children's development. However, diagnosis currently depends on clinical observation of behaviour. This is an expensive obstacle to early diagnosis and treatment. In comparison, an accurate clinical test based on urinary and plasma biomarkers described above would offer fast, robust and more cost effective method of diagnosing ASD.
Market research would indicate that the total economic costs per year for children with ASD in the United States alone are estimated between $11.5bn and $60.9 bn. Research has shown that erly intervention can improve development of the children, but diagnosis currently depends on clinical observation of behaviour. This is an expensive obstacle to early diagnosis and treatment.
We are seeking companies who wish to license the patent-application in order that they may produce a clinical test for ASD in children.
United Kingdom Patent Application: GB1802116.2 (9 February 2018)