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
Getting a clear answer about X-linked hypophosphatemia (XLH) can be life-changing, and cost should never stand in the way. The Kyowa Kirin Sponsored Hypophosphatemia Program provides genetic testing and genetic counseling at absolutely no cost to you, your family, or your doctor. Kyowa Kirin Inc. covers the full cost of the program, so there is no bill sent to you or your insurance. A faster, more accurate genetic diagnosis can also help when working with your insurance company to access the care you need.
Who this may help
Could this be right for you or your family?
- To qualify, all of the following must be met:
- A doctor is evaluating the patient for X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), and the patient is at least 6 months old (XLH) or at least 2 years old (TIO)
- The patient lives in the United States
- At least one of the following is true:
- Has completed the Kyowa Kirin Cares enrollment form
- A 1st- or 2nd-degree relative has a confirmed diagnosis of X-linked hypophosphatemia
- Has low phosphate on a lab test, plus at least two of the following:
- Low phosphate levels shown on a lab test (documented hypophosphatemia)
- At least two of these signs or symptoms:
- Muscle pain, weakness, and/or tiredness
- Bowed or deformed legs
- Bone fractures or partial fractures
- Tooth abscesses and/or a lot of cavities
- Bone or joint pain, and/or stiff joints
- Shorter-than-expected height
- Problems with walking
- Pain or stiffness where tendons attach to bone (enthesopathy)
What to expect
How the process works
- 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
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
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 the Kyowa Kirin Sponsored Hypophosphatemia Program for X-linked hypophosphatemia?
The Kyowa Kirin Sponsored Hypophosphatemia Program offers no-cost genetic testing and genetic counseling for people who may have X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO). The program uses a 13-gene panel that includes the PHEX gene, which is the primary gene linked to XLH. Testing is performed by Invitae at Labcorp, and the program is available to eligible patients in the United States.
Is genetic testing for X-linked hypophosphatemia really free through this program?
Yes, the Kyowa Kirin Sponsored Hypophosphatemia Program is completely free for patients. Kyowa Kirin Inc. pays for the entire cost of testing and genetic counseling. You will not receive a bill, and your insurance will not be charged. There are no hidden fees, copays, or deductibles.
What kind of sample is needed for the free XLH genetic test?
The Kyowa Kirin Sponsored Hypophosphatemia Program accepts a whole blood sample, a saliva sample, or a buccal swab (a gentle cheek swab). Your healthcare provider will help you choose the option that works best for you or your child. The sample collection is simple and straightforward.
How long does it take to get results from the sponsored XLH genetic test?
Results from the Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel are typically available within 10 to 21 days after the lab receives your sample. Your healthcare provider will share the results with you and can help explain what they mean. Free genetic counseling is also available through the program to help you understand your results.
Is genetic counseling included with the free X-linked hypophosphatemia testing program?
Yes, the Kyowa Kirin Sponsored Hypophosphatemia Program includes genetic counseling at no cost to you. A genetic counselor can help you understand what the test looks for, what your results mean, and what steps you might consider next. This support is part of the program and there is no extra charge for it.
Do I have to take a specific medication if I use the Kyowa Kirin sponsored XLH genetic test?
No. Participating in the Kyowa Kirin Sponsored Hypophosphatemia Program does not require you to use, purchase, or take any medication from Kyowa Kirin or anyone else. The program is designed to help you get an accurate diagnosis. Any treatment decisions remain entirely between you and your doctor.
Who qualifies for Hypophosphatemia X-linked Hypophosphatemia genetic testing?
Patients may qualify for Hypophosphatemia if they meet the program's eligibility criteria:
- 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
- Documented hypophosphatemia and two or more clinical signs/symptoms, such as:
Questions to ask your doctor about Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel
- Do you think this test is appropriate for me based on my symptoms and history?
- How could the results of this test change my diagnosis or treatment plan?
- What are the potential limitations of this test that I should understand?
- Should any of my family members also be tested based on my results?
- How will we follow up after the results are available?
Notes
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