The Kyowa Kirin Sponsored Hypophosphatemia Program

Sponsored, no-charge genetic testing
US and Canada

  • What is the Kyowa Kirin Sponsored Hypophosphatemia Program?

    Kyowa Kirin Inc. and Invitae have partnered to offer sponsored, no-charge genetic testing and counseling to patients being evaluated for a possible diagnosis of X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), are aged 6 months or older (for XLH) and 2 years or older (for TIO), reside in the United States or Canada, and meet certain other eligibility criteria.

    An accurate diagnosis may impact the clinical managmeent of hte condition, including customizing care to a patient's specific needs. The Kyowa Kirin Sponsored Hypophosphatemia Panel (13 genes) is designed to provide optimal diagnostic yield for patietns with genetic forms of hypophosphatemia, based on the current scientific understanding. This panel also provides reasonable exclusionary yield for patietns who are suspected of having TIO, in whom we would expect normal genetic test results.

    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 or TIO meet payor 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. 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.

    Have an existing Invitae account? Click Order Now below. Otherwise, please follow the instructions below for submitting a test order.

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To provide patients with genetic information that can help establish a diagnosis for XLH or TIO, the program guidelines are as follows:

While Kyowa Kirin provides financial support for this program, tests and services are performed by independent third parties.


Healthcare professionals must confirm that patients meet certain criteria to use the program.


Healthcare professionals or patients using this program are not obligated to recommend, purchase, order, prescribe, promote, administer, use, or support any Kyowa Kirin product.


No patients, healthcare professionals, or payers, including government payers, are billed for this program.


Kyowa Kirin will not receive any individual test result data, personally identifiable information, or physician ordering information. Any data that may be transmitted will be de-identified and aggregated.


Increasing access to genetic testing and counseling

About XLH

XLH, the most common form of genetic hypophosphatemia, is caused by pathogenic variants in the PHEX gene.1 XLH is an X-linked condition, meaning that the genetic variant (located on the X chromosome) only needs to exist in one copy of a patient’s genes to cause the condition. Women with XLH have a 50% chance of passing the condition to their children, regardless of gender, while men with XLH will pass it on to all their daughters and none of their sons.2

About TIO

TIO is a paraneoplastic condition of abnormal phosphorus and vitamin D metabolism caused by small, benign endocrine tumors that secrete the phosphaturic hormone, fibroblast growth factor 23 (FGF23), leading to impaired bone metabolism.3

Program eligibility

Healthcare professionals must confirm that patients meet the following criteria to use the program

Patients are eligible for this program if they are being evaluated for a possible diagnosis of X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), are aged 6 months or older (for XLH) and 2 years or older (for TIO), reside in the United States or Canada, and meet one of the following three criteria below:

  • 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

Testing options

This program offers testing with the Kyowa Kirin Sponsored Hypophosphatemia Panel

Note: Re-requisitions are not available through this sponsored testing program.

The panel tests for 13 genes:
CLCN5, CTNS, CYP2R1, CYP27B1, DMP1, ENPP1, FGF23, OCRL, PHEX, SLC34A1, SLC34A3, SLC9A3R1, VDR

icon-dna-strands-mintPolo

    How to order

    Our easy-to-order panels align with professional guidelines, making your potential next steps clearer.

    • Step 1 duotone icon

      Step 1

      Discuss testing and get consent from the eligible patient. Place your order via our convenient online portal.

    • Icon of a Test Tube with a Kit – Invitae Genetic Testing

      Step 2

      Collect your patient’s specimen using an Invitae collection kit and return it. Use the label provided to ship most samples at no additional charge from the US and Canada.

    • Genetic testing expert - Invitae icon

      Step 3

      Receive results online and access resources to guide your discussion with patient about their results.

    See how it works
    Woman smiling while providing genetic expert support

    Genetic counseling services

    Individuals in the US and Canada tested through this program are eligible for post-test genetic counseling to help them understand their test results. This service is made available by Invitae at no charge as part of the program. Patients can access genetic counseling by scheduling a session through their patient portal or by contacting Invitae Client Services at 1-800-436-3037 and asking to schedule a genetic counseling appointment.

    About Kyowa Kirin
    Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based global specialty pharmaceutical company with a more than 70-year heritage, the company applies cutting-edge science, including expertise in antibody research and engineering, to address the needs of patients across multiple therapeutic areas. Across its four regions—Japan, Asia Pacific, North America and EMEA/International—Kyowa Kirin focuses on its purpose, which is to make people smile, and is united by its shared values of commitment to life, teamwork, innovation and integrity. Learn more about the company at www.kyowakirin.com.

    References

    1. X-linked hypophosphatemia. Genetic and Rare Diseases Information Center (GARD) website. Updated 2018. Accessed January 3, 2019. https://rarediseases.info.nih.gov/diseases/12943/x-linked-hypophosphatemia.
    2. Ruppe MD. X-linked hypophosphatemia. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews. (Internet). Seattle (WA): University of Washington, Seattle; 1993-2019.
    3. Dahir K, et al. Diagnosis and management of tumor-induced osteomalacia: perspectives from clinical experience. J Endocr Soc. 2021;5(9):bvab099.

    Disclaimer: While Kyowa Kirin provides financial support for the Program, tests and services are performed by Invitae. Healthcare professionals must confirm that patients meet program eligibility criteria to use the program. Kyowa Kirin may receive deidentified patient data from this program, but at no time will Kyowa Kirin receive patient identifiable information. Genetic testing and counseling is available in the US and Canada. Healthcare professionals and patients who participate in this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use, or support any other products or services from Invitae, Kyowa Kirin, or any other third party.