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Endocrinology / Metabolic / Nephrology / MusculoskeletalX-linked Hypophosphatemia (XLH)Tumor-Induced Osteomalacia (TIO)

Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel

Evaluates 13 genes linked to hypophosphatemia, including genetic causes of XLH and tumor-related TIO, to aid diagnosis of phosphate-wasting conditions.

Accessed through the Hypophosphatemia Sponsored Testing Program•Sponsored by Kyowa Kirin Inc.•Performed by Invitae | Labcorp

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

For patients

What this test and program do

This no-charge program provides genetic testing and counseling for individuals in the US and Canada being evaluated for X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO). It is designed to support faster, more accurate diagnosis and help patients meet payer requirements for confirmatory testing. No one is billed, and participation does not obligate use of any Kyowa Kirin product.

Who this may help

Could this be right for you or your family?

  • Patients are eligible if they are being evaluated for a possible diagnosis of X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), meet the program’s age requirements, reside in the United States or Canada, and satisfy at least one of the criteria below.
  • Age Requirements:
    • XLH: 6 months or older (US & Canada)
    • TIO:
      • US: 2 years or older
      • Canada: adult patients
  • AND at least one of the following applies:
    • Documented hypophosphatemia and two or more clinical signs/symptoms, such as:
      • Muscle pain, weakness, or fatigue
      • Lower limb deformities
      • Fractures or pseudo-fractures
      • Tooth abscesses or excessive dental caries
      • Bone or joint pain, joint stiffness
      • Short stature
      • Gait abnormalities
      • Enthesopathy
    • OR a first- or second-degree relative with confirmed XLH
    • OR (US only) completion of the Kyowa Kirin Cares enrollment form

What to expect

How the process works

  1. 1

    Test Ordered

    Your provider will request an Invitae saliva, buccal, or blood collection kit and complete the required test requisition form (TRF) for your genetic test.

  2. 2

    Provide Sample

    Follow your provider’s instructions to give a sample using the kit. Your provider will return the kit and TRF to Invitae. Testing begins once both are received.

  3. 3

    Get Results

    Your provider will receive your results through the Invitae portal, typically within 10–21 days after the lab receives your sample and paperwork.

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 Invitae | Labcorp, a CLIA-certified laboratory (CLIA 05D2040778). 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 this program?

It’s a no-charge genetic testing program for people being evaluated for X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO). If you meet eligibility criteria, your healthcare provider can order the test at no cost to you.

What does the test look for?

The test analyzes 13 genes linked to genetic and acquired causes of hypophosphatemia, including PHEX (XLH) and FGF23 (TIO). Results may help confirm or rule out a genetic cause.

How do I provide a sample?

Your provider will request an Invitae saliva, buccal, or blood collection kit. You’ll follow their instructions for providing the sample.

How long does testing take?

Results are typically available 10–21 days after Invitae receives both your sample and the completed test requisition form.

Is genetic counseling included?

Yes. Individuals in the US and Canada tested through this program are eligible for no-charge post-test genetic counseling to help them understand their results. You can schedule a session directly through your patient portal or by contacting Invitae Client Services at 1-800-436-3037 and requesting a genetic counseling appointment.

Is there any cost to me or my insurance?

No. There is no billing to you, your provider, or your insurance. The program is fully sponsored by Kyowa Kirin.

Do I have to use or support any Kyowa Kirin product?

No. Participation does not require you or your provider to use, purchase, or prescribe any Kyowa Kirin medication.

Test details

  • ConditionsX-linked Hypophosphatemia (XLH), Tumor-Induced Osteomalacia (TIO)
  • Test typeTargeted NGS Panel
  • Test code4LZL3OOM
  • Genes / markers
    13
  • Key genes / markersCLCN5, CTNS, CYP2R1, CYP27B1, DMP1, ENPP1, FGF23, OCRL, PHEX, SLC34A1, SLC34A3, SLC9A3R1, VDR
  • SpecimenWhole blood•Saliva•Buccal swab
  • Turnaround time10-21 Days
  • LabInvitae | Labcorp

Next steps

Share this information with your healthcare provider 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 Invitae | Labcorp.

Questions to ask your doctor about Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel

  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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