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
This program offers no-charge genetic testing and counseling for patients in the US and Canada who may have XLH or TIO and meet age and eligibility criteria. It aims to improve diagnostic accuracy, reduce time to confirmation, and support payer coverage needs. No patients, providers, or payers are billed, and program use does not require recommending or prescribing any Kyowa Kirin therapy.
When to consider this test
Patient selection
- 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
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 is the purpose of this program?
The program provides no-charge genetic testing for patients being evaluated for XLH or TIO. It helps reduce diagnostic delays, supports earlier confirmatory testing, and may help patients meet payer criteria for ongoing care.
Which test is performed?
Testing uses the Kyowa Kirin Sponsored Hypophosphatemia 13-Gene Panel, which includes PHEX, FGF23, ENPP1, DMP1, and other genes associated with hypophosphatemia and related metabolic disorders.
Who is eligible?
Patients must meet residency and age requirements for the US or Canada and show clinical or family history consistent with XLH or TIO (integrated eligibility criteria available).
How do I order testing?
Request kits at invitae.com/request-a-kit, complete the US or Canadian test requisition form, collect the specimen, and return the kit with the TRF included. Testing begins only when both the TRF and sample are received.
What is the turnaround time?
Results are posted to your Invitae HCP portal 10–21 days after sample receipt and TRF completion.
Is genetic counseling included?
Yes. Individuals in the US and Canada tested through the program are eligible for complimentary post-test genetic counseling provided by Invitae. Patients can schedule through their online portal or by calling 1-800-436-3037 and requesting a genetic counseling appointment.
Does the program obligate me to prescribe Kyowa Kirin products?
No. There is no obligation to purchase, recommend, prescribe, or use any Kyowa Kirin product.
See an issue with this program?