Request FGF23 Test Kit

Kyowa Kirin Sponsored Hypophosphatemia Program

Through the Kyowa Kirin Sponsored Hypophosphatemia Program, HCPs can provide patients who have met one of the following eligibility criteria access to no-charge biochemical testing for FGF23 levels:

The patient is being evaluated for a possible diagnosis of X-linked hypophosphatemia (XLH) or Tumor-induced osteomalacia (TIO) and must be aged 6 months or older (XLH) or 2 years or older (TIO), reside in the United States, and meet one of the following criteria below (select one or more):
- Has documented hypophosphatemia and exhibits TWO or more of the following clinical signs and/or symptoms:
  - Muscle pain, weakness, and/or fatigue
  - Lower limb deformities
  - Fractures/pseudo-fractures
  - Tooth abscesses and/or excessive dental caries
  - Bone, joint pain, and/or joint stiffness
  - Short stature
  - Gait abnormalities
  - Enthesopathy
- OR
- Has a 1st or 2nd degree relative with a confirmed XLH diagnosis
- OR
- Has completed the Kyowa Kirin Cares Enrollment Form

Do you confirm you have a patient that meets the eligibility criteria referenced? Yes, I have a patient that meets the eligibility criteria referenced. Not at this time.

The Mayo Clinic FGF23 assay requires blood serum. HCPs must have the capability to draw blood and spin it down to serum via a centrifuge within 2 hours of blood collection. No patient or HCP may seek reimbursement for testing or blood collection processing under the Kyowa Kirin Hypophosphatemia Sponsored Testing Program from any third party, including but not limited to any government healthcare programs. If you have any questions about blood collection logistics, please email KKNA_MAsupplyrequest@kyowakirin.com.

Do you still want to proceed with ordering a FGF23 testing kit?* Yes, I would like to request a FGF23 test kit. Not at this time.

Please click the link to look up your NPI number
https://npiregistry.cms.hhs.gov/search

Email*(Used only for record-keeping purposes)

Mobile Phone number*(Used only for record-keeping purposes)

Kyowa Kirin has collaborated with Mayo Clinic Laboratories to offer sponsored, no-charge testing to patients who are being evaluated for a possible diagnosis of XLH. The Kyowa Kirin Sponsored Hypophosphatemia Program is intended to improve patient safety and quality of care by shortening the time to an accurate diagnosis, facilitate prompt confirmatory testing, and help patients with XLH meet payer coverage requirements. Use of or participation in the Kyowa Kirin Sponsored Hypophosphatemia Program does not create any obligation to use, prescribe, or recommend any Kyowa Kirin products or services. The Program is only available to patients that meet certain eligibility requirements and for whom the patient's health care provider has determined that testing is clinically appropriate. No patient or health care provider may seek reimbursement for testing or counseling services provided under the Kyowa Kirin Sponsored Hypophosphatemia Program from any third party, including but not limited to, any government health care programs.

Thank you for requesting a FGF23 test kit. Your kit will be shipped to the address you provided on the form in 3-5 business days.

If you have any questions, please email KKNA_MAsupplyrequest@kyowakirin.com

What’s included in the kit:

(1) Test Request Form
(1) Refrigerate/Ambient 10 lb Shipping Box
(1) 10 lb Styrofoam
(1) Refrigerate Specimen Bag AMC04
(1) Transfer Pipette
(1) Serum Separator Tube (SST) - 3.5 mL
(1) Aliquot Tube
(1) FedEx Return Shipping Label

Next Steps.

1. Fill out the test request form. Complete all fields and set aside.
2. Collect the blood serum specimen. Using the items provided, collect and prepare the serum specimen for lab analysis
3. Package items and send to Mayo Clinic Laboratories. Using the FedEx Return Shipping Label, send both the prepared specimen and the Test Request Form in the Refrigerate/Ambient 10 lb Shipping Box

Mayo Clinic Laboratories will analyze and fax the test results to the fax number provided on the Test Request Form. Mayo Clinic Laboratories will contact you if they have any questions.

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