Program Eligibility
Healthcare professionals must confirm that patients meet the following country-specific criteria to use the program. Please select the appropriate country tab below.
The Kyowa Kirin Sponsored Hypophosphatemia Program
Sponsored, no-charge genetic testing
US and Canada
What is the Kyowa Kirin Sponsored Hypophosphatemia Program?
- A no-charge genetic testing and counseling program for patients being evaluated for a diagnosis of X-linked hypophosphatemia (XLH) or tumor induced osteomalacia (TIO,) who meet certain age requirements and other eligbility criteria
- A program intended to improve patient safety and quality of care by shortening the time to an accurate diagnosis, facilitating prompt confirmatory testing, and helping patients with XLH or TIO meet payor coverage requirements
- 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
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, and meet one of the following 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
Genetic Testing Panel and Counseling
Certain hypophosphatemic disorders have an underlying genetic cause. It is equally important to exclude genetic causes of hypophosphatemia when evaluating for a possible diagnosis of TIO. An accurate diagnosis may impact the clinical management of the condition, including customizing care to a patient's specific needs.
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
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
Kyowa Kirin Sponsored Hypophosphatemia 13 Gene Panel
CLCN5, CTNS, CYP2R1, CYP27B1, DMP1, ENPP1, FGF23, OCRL, PHEX, SLC34A1, SLC34A3, SLC9A3R1, VDR
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.
Ordering Options
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
There are multiple options to order the Kyowa Kirin sponsored hypophosphatemia 13 gene panel
Option 1 - Paper requisition
Step 1
Request a kit and complete the test requisition form (TRF)
Request Specimen Collection Kits
1a. Request Invitae saliva, buccal, or blood specimen collection kits at: invitae.com/request-a-kitDownload and Complete the TRF
1b. Download the Invitae TRF and complete the form:
Hypophosphatemia: Order formFor Canadian providers, complete one of these forms:
Hypophosphatemia: Order form (English - Canada)
Hypophosphatemia: Order form (Français/French - Canada)
Step 2
Submit the specimen collection kit and TRF to Invitae
Collect the patient's sample using the specimen collection kit. Insert the completed TRF in the Invitae specimen collection kit and include it with sample shipment. You may also fax the order form to 415-276-4164.
Testing cannot begin until both the sample and TRF are received at Invitae.
Step 3
Complete account set up
Upon receipt of the TRF, Invitae will establish your HCP portal account and send a verfication email. You must confirm the email and create a password to access your patient's results.
Invitae will post results to your HCP portal account in 10-21 days from the time the sample and completed TRF are received.
Option 2 - Online requisition
Step 1
Sign up for an Invitae provider account
If you prefer to sign up for your online account first, click hereStep 2
Submit the specimen collection kit and TRF to Invitae
2a. Request Invitae saliva, buccal, or blood specimen collection kits at: invitae.com/request-a-kit2b. To complete the online TRF, click here
Follow the steps to submit the online TRF.
After the online TRF has been submitted, print a copy of the receipt, and enclose a copy in the specimen collection kit before shipping the sample to Invitae.
Step 3
Track your test progess and access the results
Email notifications will be sent as the test progresses through the lab and upon completion.Invitae will post results to your HCP portal account in 10-21 days from the time the sample is received and begins processing.
- If you are using an outside lab to collect the sample, it is recommended that you fax the TRF to Invitae at 415-276-4164
- Kyowa Kirin DOES NOT compensate HCPs or labs for specimen collection or handling
- 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
Questions? Contact Invitae
Program Materials
Test requisition form (US - English)