Early Stage Type 1 Diabetes Initial Screen
DBS immunoassay screen for early Type 1 diabetes: detects GAD65, IA-2, ZnT8, and insulin autoantibodies; reflexes to individual autoantibody identification.
Accessed through the UncoverT1D Sponsored Testing Program•Sponsored by Sanofi•Performed by Revvity Omics, Inc.
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
UncoverT1D is a Sanofi-sponsored program offering a no-cost ELISA-based immunoassay panel targeting GAD65, IA-2, ZnT8, and insulin autoantibodies for the early identification of autoimmune Type 1 diabetes. The program reflexes to individual autoantibody identification when clinically appropriate and may include confirmatory or follow-up testing at your discretion. Ordering carries no prescribing or purchase obligation.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Patient has a valid Health Care/Interim Health Program card and resides in Canada
- Eligibility for testing includes at least one of the following:
- First degree relative with T1D (parent, sibling, child)
- Second degree relative with T1D (cousin, aunt, uncle, niece, nephew, grandparent)
- Family history of autoimmune disease
- Personal history of autoimmune disease
- Pre-diabetes or dysglycemia
- Other
- Has requested comprehensive 4-autoantibody screening
- The comprehensive 4-autoantibody screening is not otherwise available through public coverage for the patient
Workflow
How to use this program
- 1
Verify & order
Confirm Canadian eligibility (health card, residence, no public coverage for 4-AAb), obtain consent, and submit the UncoverT1D requisition.
- 2
Collect & ship
Collect DBS per kit instructions, label appropriately, include pertinent clinical notes, and ship per program guidelines.
- 3
Review
Interpret results, counsel, and arrange confirmatory/follow-up if needed.
Billing overview
Program billing
For eligible patients, the sponsor has arrangements with the laboratory that may reduce or cover some or all of the patient's out-of-pocket cost. Actual cost and patient responsibility vary by program criteria. Refer to lab or sponsor materials for details.
Quality & privacy
Laboratory quality & data handling
Testing is performed by Revvity Omics, Inc., a CLIA-certified laboratory (CLIA 39D0673919). Your sample is processed using validated methods and quality controls to support reliable genetic results.
Your health information is handled under privacy and security practices that are intended to align with applicable regulations. For program- and lab-specific details, review the privacy information provided by the laboratory and sponsor.
FAQ
Frequently asked questions
Which patients are appropriate for the UncoverT1D Type 1 diabetes autoantibody screening program?
UncoverT1D is intended for patients being evaluated for early stage Type 1 diabetes. Ordering is at clinician discretion for patients who meet the program's eligibility criteria. The panel screens for the four islet autoantibodies most relevant to autoimmune T1D staging and can support risk stratification in your clinical workflow.
What does the UncoverT1D autoantibody panel test, and what methodology is used?
The UncoverT1D panel screens for GAD65, IA-2, ZnT8, and insulin autoantibodies using ELISA methodology. When the initial screen is positive, the assay reflexes to individual autoantibody identification. The testing is performed by Revvity Omics, Inc., and confirmatory or follow-up testing may be included as clinically indicated.
What specimen type is required for the UncoverT1D Type 1 diabetes screening?
UncoverT1D accepts dried blood spot (DBS) specimens. This collection method simplifies logistics and can be performed in any clinical setting without the need for venipuncture or cold-chain shipping. The program provides the necessary collection materials for submission to Revvity Omics.
Is there a cost or prescribing obligation when ordering the UncoverT1D autoantibody panel?
There is no cost to the patient or to the ordering clinician. Sanofi fully sponsors the UncoverT1D program, covering all testing expenses. Ordering the panel carries no purchase or prescribing obligation of any kind, allowing you to incorporate it into your clinical decision-making without financial considerations.
Is the UncoverT1D Type 1 diabetes screening program available in my practice area?
The UncoverT1D program is available to clinicians and patients in the United States. If your patient meets the program's criteria, you can order the four-autoantibody DBS panel at your discretion, and the sponsor covers all associated costs.
Does the UncoverT1D program include genetic counseling support for Type 1 diabetes screening?
UncoverT1D is an autoantibody immunoassay program, and result interpretation and patient counseling fall within the ordering clinician's scope. The program may support confirmatory or follow-up testing as clinically indicated, and you retain full discretion over the patient's care pathway following results.
Which patients are eligible for UncoverT1D Type 1 Diabetes genetic testing?
Patients may qualify for UncoverT1D if they meet the program's eligibility criteria:
- Patient has a valid Canadian Health Card/Interim Health Program card.
- Patient resides in Canada (or is currently located in Canada on a visa or similar).
- Informed consent obtained (patient or caregiver).
- Patient meets screening eligibility criteria for UncoverT1D.
- Patient does not have publicly covered access to comprehensive 4-AAb testing.
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