Welcome to Account Services. If you have a PreDx account, you can order office materials and testing supplies, review answers to frequently asked questions and access free diabetes prevention tools for your patients.
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Order test processing kits that include everything you need to successfully order, process and ship PreDx blood specimens.GO TO THE FORM
Review answers to common questions about the PreDx test.GO TO FAQ SHEET
PreDx is a multi-biomarker prognostic blood test that is unique in its ability to:
• Predict the 5-year likelihood of progression to type 2 diabetes in patients with prediabetes
• Monitor patient response to lifestyle interventions that are part of a diabetes prevention strategy
The PreDx test includes seven biomarkers linked to multiple systems involved in the pathogenesis of type 2 diabetes:
The greatest challenge facing practitioners today is not determining which patients have prediabetes (FPG and A1C are suitable for that purpose), but identifying which of these patients is most likely to progress to type 2 diabetes. Given that studies have shown that only 10% of them will progress to diabetes within the next 5 years (Nichols G, Hillier T, MD, Brown J, et al. Diabetes Care. 2007; 30(2):228-233), and that timely intervention could change that outcome, the need to identify those patients with the highest likelihood of progressing to type 2 diabetes becomes even more urgent.
The PreDx test answers this need, by enabling practitioners to:
PreDx baseline and follow-up testing results are intended to be used in conjunction with other clinical information to aid healthcare providers in determining appropriate strategies to delay or prevent the onset of type 2 diabetes in patients with prediabetes, and to monitor the efficacy of interventions, so that timely modifications can be made as needed to optimize patient response. PreDx is not a genetic test, nor a test to be used for diagnosing type 2 diabetes.
FPG, A1C and OGTT are single-marker tests that measure glucoregulatory function alone. PreDx is a multiple-biomarker test that measures seven analytes from three critical systems implicated in the development of type 2 diabetes – glucose regulation, inflammation and adipocyte health. This more comprehensive multi-factorial assessment yields a more accurate profile of the underlying metabolic picture, and enables the stratification of patients according to their 5-year likelihood of progression to type 2 diabetes.
No. FPG and A1C are sensitive tests that should be used to screen for prediabetes. However, they are not very specific tests, therefore are not ideal for determining which patients with prediabetes will progress to type 2 diabetes. The multi-biomarker PreDx test overcomes this limitation by providing the level of specificity necessary to determine the 5-year likelihood of progression from prediabetes to type 2 diabetes.
The PreDx score is a single number that stratifies patients with prediabetes into “low”, “moderate” and “high” categories based on their likelihood of progressing to type 2 diabetes within 5 years. Results are presented on a progressive scale of 1 (low likelihood of progression) to 9.9 (high likelihood of progression). (Kolberg J, Jørgensen T, Gerwien RW, et al. Development of a type 2 diabetes risk model from a panel of serum biomarkers from the Inter99 cohort. Diabetes Care. 2009;32(7)1207-12.; Lyssenko V, Jørgensen T, Gerwien RW, et al. Validation of a multi-marker model for the prediction of incident type 2 diabetes mellitus: combined results of the Inter99 and Botnia studies. Diab Vasc Dis Res. 2012;9(1):59-67).
The PreDx score is derived from an algorithm that combines results from the seven PreDx biomarkers with age and gender, to produce a numerical score that ranks a patient’s 5-year likelihood of progression to type 2 diabetes on a scale of 1 (lowest likelihood) to 9.9 (highest likelihood) (Kolberg J, Jørgensen T, Gerwien RW, et al. Development of a type 2 diabetes risk model from a panel of serum biomarkers from the Inter99 cohort. Diabetes Care. 2009;32(7)1207-12.; Lyssenko V, Jørgensen T, Gerwien RW, et al. Validation of a multi-marker model for the prediction of incident type 2 diabetes mellitus: combined results of the Inter99 and Botnia studies. Diab Vasc Dis Res. 2012;9(1):59-67).
Yes, the development and clinical validation of the PreDx test is described in numerous peer-reviewed publications.
Any patient 18 years of age or older who has been determined to have prediabetes is a candidate for the PreDx test.
Patients need to fast for a minimum of 10 hours prior to their blood draw.
An account with the Tethys Clinical Laboratory (TCL) must be established before PreDx test can be ordered.
There are no special requirements for the PreDx test performed using the finger stick sample collection method. However, performance of the PreDx test using venous blood requires in-office phlebotomy, and access to FedEx shipping services.
Once your account has been established, TCL will send you a supply of Test Requisition Forms (TRF) and test kits that provide everything needed to process specimens, including specimen tubes, packing materials and shipping supplies.
As soon as you receive your Test Requisition Forms and test kits, you can begin ordering PreDx for your patients with prediabetes.
To order a test, simply complete the PreDx Test Requisition Form (TRF), and enclose it with the patient’s specimens to be packaged and shipped to the Tethys Clinical Laboratory.
No special equipment is required for the PreDx test performed with the fingerstick sample collection method. The PreDx test performed with venous blood requires in-office phlebotomy and access to:
The turn-around time for PreDx test results is approximately 7 days after receipt of specimens at the Tethys Clinical Laboratory. This time frame may be impacted if an inaccurate or incomplete Test Requisition Form is submitted, or if there are problems with the specimens.
The PreDx test report provides results for the patient’s most recent test (score plus seven individual biomarkers), as well as those for up to three previous tests. The historical data provided enables:
The PreDx report differs from a typical laboratory report because it is designed to function as a patient counseling tool as well as a content-rich clinical resource for clinicians:
Results of the European Diabetes Prevention Study (EDIPS) showed that reductions in PreDx scores following lifestyle intervention correlate with reductions in the development of type 2 diabetes.
Since changes in a patient’s PreDx score reflect their response to lifestyle interventions, retesting at regular intervals enables clinicians to use short-term changes in PreDx scores to assess prevention strategies, and alter them as needed in those patients who are not responding.
The frequency of PreDx retesting is determined by the treating physician. However, a reference document entitled “Patient Management Considerations,” which was compiled by twelve primary care clinicians experienced with PreDx, includes recommended retesting intervals for low-, moderate- and high-score patients:
The PreDx test is currently an out-of-network test that is reimbursed by most private insurance carriers. As the exclusive laboratory service provider for the PreDx test, Tethys will bill your patients' insurance providers directly for laboratory services.
As of May, 2113, 15 manuscripts have been published in peer-reviewed journals regarding PreDx development, validation, clinical utility and use in primary care practice. In addition, 23 abstracts have been presented at national and international scientific congresses.
Contact PreDx Client Services and we'll be happy to answer your questions directly.