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EndocrinologyType 1 Diabetes

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 help patients understand the purpose of testing and what to expect.

For patients

What this test and program do

If you or your child may be at risk for Type 1 diabetes, catching it early can make a real difference. UncoverT1D is a sponsored screening program that checks for four autoantibodies your immune system may be producing before obvious symptoms appear. The program is fully covered by Sanofi, so there is no cost to you, and your doctor can order the test whenever they feel it is the right step for your care.

Who this may help

Could this be right for you or your family?

  • To qualify, all of the following must be met:
    • The patient lives in Canada and has a valid Health Care or Interim Health Program card
    • At least one of these is true:
      • A parent, sibling, or child has type 1 diabetes
      • A cousin, aunt, uncle, niece, nephew, or grandparent has type 1 diabetes
      • There is a family history of autoimmune disease
      • The patient has a personal history of autoimmune disease
      • The patient has pre-diabetes or dysglycemia
      • Another reason the provider identifies
    • The comprehensive 4-autoantibody screening is not otherwise covered by public health insurance

What to expect

How the process works

  1. 1

    Discuss & enroll

    Your clinician confirms you’re eligible, explains the program, and completes consent.

  2. 2

    Give sample

    Follow the kit instructions; your clinic handles labeling and shipping.

  3. 3

    Get results

    Your clinician receives the report and reviews what it means and any next steps (including confirmatory or follow-up testing if needed).

Cost & coverage

Understanding potential costs

If you qualify for this program, the sponsor works with the laboratory to help make testing more affordable. Many patients pay little or no out-of-pocket cost. Your exact cost will depend on your insurance coverage and the specific criteria of the program, and the lab can explain what to expect before your sample is processed.

Quality & privacy

How your sample and information are handled

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

Common questions about this program

What is the UncoverT1D program for early stage Type 1 diabetes screening?

UncoverT1D is a no-cost screening program that looks for four specific autoantibodies associated with early stage Type 1 diabetes: GAD65, IA-2, ZnT8, and insulin autoantibodies. These markers can show up before symptoms develop, which means you and your doctor may have more time to plan next steps. The testing is performed by Revvity Omics, Inc., a specialized laboratory, and your clinician will walk you through your results.

Is the UncoverT1D Type 1 diabetes screening really free?

Yes, the UncoverT1D program is completely free to you. Sanofi, the program's sponsor, covers the full cost of testing. You will not receive a bill, a copay, or any charge for the screening. Your only step is to talk with your doctor about whether this test makes sense for you or your child.

What kind of sample is needed for the UncoverT1D Type 1 diabetes autoantibody test?

The UncoverT1D screening uses a dried blood spot, which is a small sample of blood collected on a special card. This is a simple collection method that does not require a traditional blood draw from a vein. Your doctor's office will handle the sample collection and send it to the lab on your behalf.

What autoantibodies does the UncoverT1D screening test for?

The UncoverT1D panel checks for four autoantibodies that are linked to Type 1 diabetes: GAD65, IA-2, ZnT8, and insulin autoantibodies. If the initial screen detects autoantibodies, the test can reflex to identify which specific ones are present. Your clinician will explain what the results mean and whether any follow-up testing or monitoring is needed.

Can I get genetic counseling with the UncoverT1D Type 1 diabetes screening?

UncoverT1D is an autoantibody screening program, and your ordering clinician is the best person to discuss your results and what they mean for your health. If your doctor feels you would benefit from additional counseling or follow-up testing, they will guide you through those next steps as part of your ongoing care.

Who qualifies for UncoverT1D Type 1 Diabetes genetic testing?

Patients may qualify for UncoverT1D if they meet the program's eligibility criteria:

  • You have a valid Canadian health card (or Interim Health Program card).
  • You live in Canada (main residence in Canada, or you’re currently in Canada on a visa or similar).
  • You (or your caregiver) have provided informed consent.
  • You meet the screening criteria your clinician uses for this program.
  • You do not already have publicly covered access to comprehensive 4-autoantibody testing.

Test details

  • Formal test nameEarly Stage Type 1 Diabetes Initial Screen (with reflex to individual autoantibody identification)
  • ConditionType 1 Diabetes
  • Test typeELISA
  • Test codeT1D001 + T1D002
  • Genes / markers
    4
  • Key genes / markersGAD65 (GADA), IA-2A, ZnT8A, IAA
  • Specimen
    Dried blood spot (DBS)
  • Turnaround timeNot specified
  • LabRevvity Omics, Inc.
  • Program regionCanada

Next steps

Share this information with your endocrinologist or genetic specialist. They can help determine whether this test and program are appropriate for you.

Or ask your doctor to search for this test by name at Revvity Omics, Inc..

Questions to ask your doctor about Early Stage Type 1 Diabetes Initial Screen

  1. Do you think this test is appropriate for me based on my symptoms and history?
  2. How could the results of this test change my diagnosis or treatment plan?
  3. What are the potential limitations of this test that I should understand?
  4. Should any of my family members also be tested based on my results?
  5. How will we follow up after the results are available?

Notes

See an issue with this program?

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