 |
|
|
||||||||||||||
 |
|
|
The development of diabetes is heterogeneous with complex biology underlying the disease process
- Insulin resistance and dysfunction of pancreatic beta cells are central abnormalities of diabetes.
- Insulin resistance is a disordered state in which insulin inadequately stimulates glucose transport in skeletal muscle and fat and inadequately suppresses hepatic glucose production.
- Glucose intolerance and subsequent diabetes develop as the compensatory hypersecretion of insulin as beta cells decline.
The PreDx™ Diabetes Risk Test — how did we get here?
The Tethys process began with a comprehensive search of scientific and clinical literature in an effort to identify all biomarker candidates associated with disease development. The screened biomarkers covered many possible pathways associated with diabetes progression, and each biomarker was assessed for utility and relevance. The list of candidate biomarkers contained over 260 markers and assays were developed for over 89 markers.
Today, the PreDx Diabetes Risk Test utilizes diverse biomarkers related to inflammation, fat and carbohydrate metabolism, coagulation and cell death. It is able to assess changes related to multiple aspects of the disease process, not just glucose metabolism.
Each assay was validated and the performance characteristics were established by the Tethys Clinical Laboratory. Background information and confidence intervals are provided on each test report to the ordering physician.
Clinical Development of PreDx Risk Score using Population based Cohort
(Inter99)1-3
- Retrospective baseline blood samples were tested from a large population of healthy subjects.
- Using sensitive Molecular Counting Technology, which has the ability to detect a single molecule in an extremely small blood sample, 89 markers were quantified.
- Over a 5-year period, 6% of subjects developed diabetes.
- Based on blood markers initially present in the blood of those 6% subjects, Tethys narrowed their broad scope of 89 markers down to less than 20 markers with higher or lower levels common to those who had developed diabetes.
- The small group of people identified as high risk by the biomarkers had a four times higher than average chance of developing diabetes within 5 years.
- Conversely, based on their score, over half the subjects had a four times lower likelihood of developing diabetes in 5 years.
- Of those who developed diabetes, 23% had normal blood glucose at the beginning of the study.
1. Population description: Jørgensen T, Borch-Johnsen K, Thomsen TF, Ibsen H, Glumer C, Pisinger C. A randomized non-pharmacological intervention study for prevention of ischaemic heart disease: baseline results Inter99. European Journal of Cardiovascular Prevention and Rehabilitation 2003;10:377-386.
2. Kolberg J, Gerwien R, Moler E, Rowe M, Urdea M, McKenna M, Hansen T, Pedersen O, Jørgensen T. Training and validation of a multimarker algorithm for the prediction of Type 2 diabetes from a 5 yr prospective study of 6,784 Danish people (Inter99). American Diabetes Association 68th Scientific Sessions, 2008.
3. Data on file, Tethys Clinical Laboratory, Tethys Bioscience, Inc., 2008
Nov 20, 2008
Tethys Bioscience Joins National Diabetes Goal
Company joins national move to ensure Americans know their risk of developing Type 2 Diabetes.
Sep 17, 2008
Tethys Bioscience Announces Acquisition of Lipomics Technologies
Addition of metabolite technology uniquely positions company as it expands its line of predictive diagnostic tests
Jul 2, 2008
Tethys unveils advanced-warning test for diabetes by Michael Fitzhugh
Tethys Bioscience Inc. is launching a new test that can identify people at high risk of developing Type 2 diabetes within five years - allowing them to take steps to reduce their risk.
(East Bay Business Times Friday, June 13, 2008)
Jul 2, 2008
A Predictive Tool for Diabetes By Thomas Goetz
Thomas Goetz, deputy editor of Wired magazine, wrote about Tethys and the PreDx Diabetes Risk Test on his personal blog, which tracks trends and technologies in medicine and health.
(Epidemix.org)
Jun 9, 2008
Diabetes test gives 5-year disease-prediction window.
There is an old saying that seems appropriate when describing Tethys Bioscience's PreDx Diabetes Risk Test: Forewarned is forearmed.
(Medical Device Daily)
Jun 7, 2008
Tethys Bioscience Announces Expanded Availability of PreDx™ Diabetes Risk Test
A Powerful New Tool for Early Identification of High Risk Patients
Early Intervention Can Help Prevent Disease Progression