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TheraGuide® 5-FU FAQs

TheraGuide® 5-FU Questions and Answers

How common is 5-FU toxicity?

How prevalent are clinically significant DPYD and TYMS variants?

What is the risk of toxicity due to DPYD and TYMS variations?

Who is a candidate for the TheraGuide test?

How is the TheraGuide test performed?

Why is this test unique?

How do I order the test?

Is the test covered by insurance?

Do I need to provide ICD-9 codes?

What is the turnaround time for the TheraGuide test?

How common is 5-FU toxicity?

As many as 1 in 5 patients receiving 5-FU therapy experience dose-limiting toxicity that is largely avoidable.

How prevalent are clinically significant DPYD and TYMS variants?

Up to 25% of individuals have variations in the DPYD and/or TYMS genes that are associated with an increased risk of toxicity to 5-FU.

What is the risk of toxicity due to DPYD and TYMS variations?

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.

Who is a candidate for the TheraGuide test?

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.

How is the TheraGuide test performed?

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.

Why is this test unique?

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.

How do I order the test?

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.

Is the test covered by insurance?

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.

Do I need to provide ICD-9 codes?

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.

What is the turnaround time for the TheraGuide test?

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.)
 

 

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