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 support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
The Kyowa Kirin Sponsored Hypophosphatemia Program provides no-charge genetic testing and counseling for patients under evaluation for X-linked hypophosphatemia or tumor-induced osteomalacia. The program is designed to support faster diagnostic confirmation and help meet payer requirements for confirmatory genetic evidence. Kyowa Kirin Inc. covers all costs; no patient, provider, or payer is billed, and ordering carries no obligation to recommend or prescribe any Kyowa Kirin product.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Being evaluated for X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), and aged 6 months or older (XLH) or 2 years or older (TIO)
- Resides in the United States
- Meets at least one of the following:
- Has completed the Kyowa Kirin Cares Enrollment Form
- Has a 1st or 2nd degree relative with a confirmed X-linked hypophosphatemia diagnosis
- Documented hypophosphatemia and two or more of the following:
- Documented hypophosphatemia
- Two or more of the following clinical signs/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
Workflow
How to use this program
- 1
Order Kits & TRF
Order Invitae saliva, buccal, or blood kits at invitae.com/request-a-kit. Download and complete the appropriate TRF for U.S. or Canada before sample collection.
- 2
Submit Sample
Collect the specimen using the Invitae kit and return it with the completed TRF. You may also fax the TRF to 415-276-4164. Testing starts only when both items are received.
- 3
Access Results
Once the TRF is received, Invitae sets up your HCP portal account and emails a verification link. After activation, results will be posted within 10–21 days of receiving the sample and TRF.
Billing overview
Program billing
For eligible patients, the sponsor has arrangements with the laboratory that may reduce or cover some or all of the patient's out-of-pocket cost. Actual cost and patient responsibility vary by program criteria. Refer to lab or sponsor materials for details.
Quality & privacy
Laboratory quality & data handling
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
Frequently asked questions
What genes are covered on the Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel?
The Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel includes 13 genes associated with hypophosphatemia, with PHEX as the primary gene of interest for XLH. Testing is performed via next-generation sequencing (NGS) by Invitae at Labcorp. The panel is also relevant for the evaluation of tumor-induced osteomalacia.
Which patients are appropriate for the sponsored XLH genetic testing program?
The Kyowa Kirin Sponsored Hypophosphatemia Program is intended for patients being evaluated for X-linked hypophosphatemia or tumor-induced osteomalacia who meet the program's eligibility criteria. Healthcare professionals must confirm that their patients meet these criteria before ordering. The program is available in the United States.
What specimen types are accepted for the Kyowa Kirin Hypophosphatemia 13 Gene Panel?
The Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel accepts whole blood, saliva, or buccal swab specimens. Kits can be requested through Invitae. This flexibility in specimen type supports ease of collection across clinic settings, including pediatric patients.
What is the turnaround time for results from the sponsored hypophosphatemia genetic test?
Turnaround time for the Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel is 10 to 21 days from specimen receipt. Results are delivered through the standard Invitae reporting workflow. Genetic counseling is included at no charge to support result interpretation and patient communication.
Is genetic counseling available through the Kyowa Kirin Sponsored Hypophosphatemia Program?
Yes, the Kyowa Kirin Sponsored Hypophosphatemia Program includes genetic counseling at no cost. Counseling services are available to support both pre-test and post-test discussions with patients and their families. This can be particularly valuable for complex or unexpected findings on the 13-gene panel.
Does ordering the sponsored XLH test obligate me to prescribe any Kyowa Kirin product?
No. Healthcare professionals and patients who participate in the Kyowa Kirin Sponsored Hypophosphatemia Program have no obligation to recommend, purchase, order, prescribe, promote, administer, use, or support any products or services from Kyowa Kirin, Invitae, or any other third party. The program is designed solely to support accurate diagnosis.
Who covers the cost of the Kyowa Kirin Sponsored Hypophosphatemia genetic testing program?
Kyowa Kirin Inc. covers the full cost of testing and genetic counseling through this program. No charges are billed to the patient, the ordering clinician, or any payer. The program is intended to remove financial barriers to confirmatory genetic testing for hypophosphatemia.
Which patients are eligible 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)
- 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:
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