Cancer Treatment Today

The OnDose™ test is offered by Myriad Genetics as a laboratory-developed test. Other clinical laboratories may offer in-house assays to measure 5-FU AUC. Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratories offering such tests as a clinical service must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA) and must be licensed by CLIA for high-complexity testing. Myriad Genetics is a CLIA-licensed laboratory.

It is known that there is the wide variability of 5-fluorouracil (5-FU) plasma levels when patients
are placed on a fixed-dose regimen. Some of it has to do with metabolic differences and some with DPD Dehydrogenase level variations among individuals; high exposure is associated with toxicity, but higher exposure up to the limits of toxicity is also associated with better tumor response to treatment. Area under the curve laboratory testing is tempting to better assess and adjust 5-FU exposure during treatment of cancer and validated algorithms to modify subsequent dosing may improve response and reduce toxicity, but currently available evidence is insufficient to support such testing. Because the impact of this testing on net health outcome is not known, this is considered experimental, investigational and unproven.

Grem JL. 5-Fluorouracil and its biomodulation in the management of colorectal cancer. In:
Saltz LB, ed. Colorectal Cancer: Multimodality Management. Totowa, NJ: Humana Press;
2002.

OnDose® Technical Specifications, Myriad Genetic Laboratories, Inc. June 2010. Available
at: <www.myriad.com> (Accessed January, 2011).

TEC Special Report: Laboratory Testing to Allow Area Under the Curve (AUC) –Targeted 5-
Fluorouracil Dosing for Patients Administered Chemotherapy for Cancer. Chicago, Illinois:
Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program
(2010 June) 24(10):1-28.