TheraGuide® 5-FU FAQs
TheraGuide® 5-FU Questions and Answers
As many as 1 in 5 patients receiving 5-FU therapy experience dose-limiting toxicity that is largely avoidable.
Certain variations in the DPYD gene are associated with up to a 7-fold increased risk for dose-limiting toxicity from 5-FU-related therapy. In patients with TYMS variations, there is up to a 1.4- to 2.5-fold increased risk.
Any patient being considered for 5-FU-related therapy is a candidate for TheraGuide. There is a huge potential benefit for the patient in determining toxicity risk prior to starting 5-FU chemotherapy or at the beginning of his or her regimen. By assessing the risk of 5-FU toxicity, oncologists can identify patients who may not effectively metabolize 5-FU and follow up with refined therapeutic choices for improved outcomes.
Sample requirements are 7 mL of blood collected in a lavender-top EDTA tube, which is then sent to Myriad Genetic Laboratories, Inc. at ambient temperature. A sample kit can be order through our Online Order Form or by contacting your Customer Service Specialist at 800-469-7423.
TheraGuide testing by Myriad is the most comprehensive test available for assessing the risk of gene-related 5-FU toxicity and is the only diagnostic test offering full sequencing of DPYD, as well as analysis of the TYMS gene.
Healthcare providers may request a test kit by using our Online Order Form. The kit will have a test request form and sample checklist for further details. You can also order a complimentary test kit by contacting your Myriad Customer Service Specialist at 800-469-7423.
Many insurance companies cover TheraGuide, and we expect more insurance coverage over time. As with any newer service, we may request a Letter of Medical Necessity or other assistance to help secure reimbursement.
Our reimbursement specialists require accurate ICD-9 codes to aid with billing and other activities. The Test Request Form (TRF) includes a section called Ancestry & Clinical History with a subheading called What Kind of Cancer Does This Patient Have? where physicians must enter a listing of ICD-9 code(s). All ordering healthcare providers must complete this section to begin test processing. Please contact Myriad Customer Service at 800-469-7423 for more information.
Expected turnaround time is within 7 days after receipt of the test, provided the TRF is accompanied by the blood sample and is filled out properly, including billing option information. (Insurance billing requires a patient signature and readable [enlarged] copy on both sides of insurance card[s]. If 2 cards are submitted, please indicate which is primary.)