Background:
Currently, diabetes testing is implemented later in life or at the onset of symptoms. Our diagnostic assay is significantly improved to be utilized in pre-diagnostic testing, and useful for the detection, prevention and/or treatment of diabetes and other autoimmune diseases. Our method has the unique ability to use any blood fraction to measure elevated concentrations of IGF-1 and to diagnose and detect for the predisposition to diabetes in as early as a newborn. The following threshold values were developed to support a predisposition or a positive diagnosis: IGF-1 concentration in whole blood, dried blood, serum or plasma of 3 ng/mL or above is a diagnosis for predisposition to developing diabetes and IGF-1 of 6 ng/mL or above supports a positive diagnosis of diabetes.
Applications:
- A novel diagnostic assay used to screen for predisposition to Type 1 diabetes and other autoimmune diseases
- A kit comprising reagents including antibodies against members of a given panel of analytes
Advantages:
- Accurate method of diagnosing diabetes in humans, preferably newborns
- Unique ability to expedite an early diagnosis for intervention in the pathological process
- Applicable to numerous autoimmune diseases
- Identifies high-risk individuals enabling early detection and treatment to maximize effective treatment
- Any blood fraction can be tested to determine levels of IGF-1
State of Development:
Diagnostic assay available for use
Patents:
Patent pending.
Licensing Potential:
HRI is seeking commercial partners to produce the diagnostic assay and develop the kits for large-scale newborn screening applications. Available for licensing.
Inventors:
Samuel T. Labrie, Ph.D., Michael D. Spain, Ph.D., James P. Mapes, Ph.D., Ralph L. Mc Dade, Ph.D. and
Kenneth Pass, Ph.D.
For 28 years Dr. Kenneth Pass was director of the NYS Newborn Screening Program. During that time he introduced screening for biotinidase deficiency, congenital adrenal hyperplasia, and Krabbe disease. The NY program was the first to use a call-in system by which physicians could obtain test results on any day at any time, the first to provide a portion of the specimen form for the mother to facilitate acquisition of test results, the first to implement HIV testing of all newborns, and the first to test for the LSDs. He has published over 80 peer reviewed papers, eight book chapters, and delivered lectures all over the world on many different aspects of NBS. With funding from NICHD he has developed multiplex assays that screen for CH/CF/CAH (5-plex), SCID (2-plex), and autism (7-plex), all using a single 3 mm spot. Currently his laboratory is developing a multiplex assay for hemoglobin variants that can be added to each of the above, thereby allowing calculation of the hematocrit and normalization of test results.
Summary:
Pre-Diagnosis for Diabetes Biomarker
Contact:
Diane L. Borghoff, B.S., M.S.
Marketing & Licensing Associate – Intellectual Property
Health Research, Inc.
150 Broadway – Suite 560, Menands, New York 12204-2719 U.S.A.
Phone 518-431-1213 Fax 518-431-1234
E-mail: DLB22@healthresearch.org Website: www.healthresearch.org
