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CMCC 2183

Specific and sensitive diagnostic markers of Kawasaki disease

Inventors: Alex Kentsis, Hanno Steen, Susan Kim

Categories: Diagnostic/Prognostic

SubCategories: Immunology

Keywords: Biomarker

Case Image

Receiver operating characteristics of urine protein markers validated by enzyme-linked immunosorbent assays (ELISA) as compared to the currently used diagnostic tests of Kawasaki disease.

Invention Description:

Although the incidence of Kawasaki disease (KD) is rare (annual incidence of 50 - 175/100,000 in children <5 years of age) it is the most common cause of acquired heart disease of children in the developed world. The etiology and pathogenic mechanisms are unknown. The common presenting features (such as prolonged fever and rash) belie the severity of the underlying vascular inflammatory damage and without treatment, 25% of patients develop coronary artery aneurysms. Importantly, because the presentation of Kawasaki disease often mimics that of many common childhood febrile illnesses, Kawasaki disease is often suspected in children with prolonged fever.

Susan Kim, MD, MMSc, (Rheumatologist and lead clinical investigator), Alex Kentsis, MD, PhD (lead co-investigator) and Hanno Steen, PhD (Director of Children’s Proteomics Center) have analyzed the protein composition of urine of patients with distinguish Kawasaki disease. For the initial discovery of biomarkers, patients with fever evaluated for Kawasaki disease were studied using exhaustive protein capture and high-accuracy mass spectrometry. Using this approach >2000 unique proteins were identified, of which 190 were uniquely measured in patients with active Kawasaki disease. Urine samples were collected from all subjects at the time of their diagnostic work-up and following successful treatment.

Three markers were confirmed by enzyme-linked immunosorbent assay (ELISA) in a large cohort of patients evaluated for Kawasaki Disease. The levels of these proteins exhibited superior diagnostic performance compared to currently used markers of disease with receiver operating characteristic areas under the curve of 0.85, 0.94 and 0.99 and correlated with disease activity, providing sensitive and specific diagnostic markers. Their validation using commonly available ELISAs offers diagnostic tests with immediate translation to clinical practice.

In addition, these biomarkers were elevated in the serum of a mouse model of Kawasaki disease and immunohistochemistry showed that these markers were enriched in the coronary artery lesions of a mouse model of KD.

Applications:

Diagnostic immunoassay specific for Kawasaki disease
• Rule-out test targeted to all children with prolonged fever
• Rule-in test to confirm suspected Kawasaki disease before initiation of treatment

Competitive Advantages:

• There are more than 6 million pediatric admissions for fever in the US per year, with an aggregate cost of $30 billion.
• Kawasaki disease clinically mimics other common conditions and diagnosis is often subjective and equivocal
• There is no definitive diagnostic marker for KD

• Product
o accurate, rapid, and non-invasive test
o analytical and point-of-care test for ED, hospital- and office-based physicians

• Advantages
o accuracy and timeliness of evaluations
o may be able to avoid unnecessary hospitalizations, treatments, procedures
o low cost, widespread incorporation into clinical practice

Business Opportunity:

Exclusive or non-exclusive license

Key Publications: Kentsis A, Shulman A, Ahmed S, Brennan E, Monuteaux MC, Lee YH, Lipsett S, Paulo JA, Dedeoglu F, Fuhlbrigge R, Bachur R, Bradwin G, Arditi M, Sundel RP, Newburger JW, Steen H, Kim S. Urine proteomics for discovery of improved diagnostic markers of Kawasaki disease. EMBO Mol Med. 2013 Feb;5(2):210-20. doi: 10.1002/emmm.201201494. Epub 2012 Dec 20. PubMed PMID: 23281308; PubMed Central PMCID: PMC3569638.

IPStatus: Pat. Pend.

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