The Elucigene DPYD assay (ONDYDR1) is a research use only test designed for the detection of the followingDPYD gene mutations in DNA extracted from whole blood (EDTA preserved). <br>

The device is for Research Use Only within a molecular or oncology laboratory environment. <br>

5-Fluorouracil (5-FU) is a chemotherapy used to treat a range of cancers including head and neck, breast,pancreatic, stomach, and colorectal. 5-FU is metabolized by the dihydropyrimidine dehydrogenase enzyme (DPD)which is encoded by the DPYD gene. <br>

Several variants within DPYD have been described that lead to reduced orabolished DPD activity. Patients with these variants are at an increased risk of severe or fatal 5-FU toxicity (1-3).Therefore, implementation of DPD deficiency screening will allow a more accurate prediction of toxicity andchemotherapeutic response.The Elucigene DPYD product will allow affordable and fast routine testing for patients beginning 5-FU therapy withthe aim of reducing the likelihood of adverse drug reactions and toxicity. An estimated two million people are treatedwith 5-FU derived drugs annually and 10-20% of these patients are hospitalized as a result of toxicity duringtreatment (5-8). Mercier et al., 2006 (9) demonstrated that the cost of treatment per patient was lower with screeningthan without, highlighting the need for routine genetic testing.