This Small Business Innovative Research Phase I project outlines steps to design and optimize a multiplex panel, based on the FDA approved Luminex 200 platform, which will distinguish systemic juvenile idiopathic arthritis (sJIA) from other febrile illnesses. Ascendant Dx is obtaining exclusive license to a protein biomarker panel which preliminary data indicates can differentiate between sJIA flare and other illnesses including: sJIA quiescence, Febrile Illness (FI), and Kawasaki Disease (KD) samples. sJIA affects 1 in 10,000 children and is difficult to diagnose. Current diagnostic measures include eliminating all other possible febrile illnesses before a sJIA diagnosis can be given, this takes time and money to complete. While tests are being conducted to rule out other causes the child continue to suffer from symptoms and in many cases will need to be hospitalized and placed on intravenous antibiotics until a diagnosis has been reached. Many of these diagnostic tests are painful and invasive for children. The average age of a child at the time of diagnosis is 1 to 2 years of age, however, this disease has no gender or age preference. In many cases this disease is polycyclic causing a patient to go through periods of the active (flare) and inactive (quiescence) forms of the disease. Plasma samples for this project will be obtained through the Childhood Arthritis and Rheumatology Research Alliance (CARRA). Using 15 sJIA flare and 15 healthy controls, Ascendant Dx will first test each biomarker independently to ensure the MILLIPLEX MAP panel data is consistent with data previously obtained using commercially available ELISA assays. Once that is confirmed, the markers will then be combined into a signal panel and tested with the same plasma samples used for the MAP panel study to assess potential signal reduction as a result of the multiplex assay. Following successful combination of the markers, the diagnostic threshold will be determined using 50 plasma samples from sJIA flare, sJIA quiescence, FI, KD, and healthy control. After the threshold values have been established, a blinded study will be conducted using a cohorts of 250 plasma samples from patients with sJIA flare and quiescence, FI, KD, and healthy control to determine sensitivity and specificity. Upon successful completion of these objectives sufficient data will have been collected to propose a prototype diagnostic assay for use in clinical laboratories in a Phase II application. This diagnostic test will provide a quick and easy way for doctors to diagnose sJIA where currently nothing is available.
Ascendant Dx is seeking to meet a need in the field of pediatric rheumatology by developing a multiplex assay for the diagnosis of systemic juvenile idiopathic arthritis (sJIA). This test will require a small amount of blood (50ul) and will be ableto distinguish patients who have sJIA from patients who have other febrile illnesses, including Kawasaki's disease. Currently, there is no diagnostic test for sJIA and the current diagnostic method is constant clinical testing to eliminate all other potential febrile illnesses, which could account for the patient's symptoms. This approach is quite costly, time intensive, and difficult on both the patient and the family. A multiplex diagnostic assay for sJIA will reduce time, cost and mental strain associated with the current diagnostic method.
