Today, Oxford Cancer Biomarkers are pleased to announce the publication of the ToxNav ® clinical validation study in the journal Cancers. This milestone represents a significant step forward for OCB and the ToxNav ® brand.
ToxNav ® is OCB’s flag ship precision oncology product and is being offered routinely to patients in several NHS Trusts and private hospital groups in the UK. The ToxNav ® assay identifies patients carrying genetic variants of DPYD and TYMS/ENOSF1. They are associated with an increased risk of severe side effects ahead of treatment with fluoropyrimidine based chemotherapy. This allows patients and clinicians to make informed treatment decisions on an individual basis. ToxNav ® is the second product developed by OCB to hold a CE mark.
Fluoropyrimidines are first line treatment in patients with colorectal cancer. These drugs are also widely used in other cancers including breast cancer and a range of gastrointestinal malignancies.
ToxNav ® is the most comprehensive DPYD test available. ToxNav screens for 20 different variants, including rare variants and variants observed at increased frequency in ethnic populations. In addition to variants associated with severe side effects that may lead to hospitalisation, ToxNav also includes variants linked to an increased risk of hand-foot syndrome (HFS). The publication of the ToxNav ® validation data goes one step further towards widening access to all patients in the UK who are about to commence 5-FU or capecitabine chemotherapy.
About ToxNav ®
ToxNav ®, is a comprehensive panel of 20 genetic variants associated with 5FU/capecitabine toxicity in the DPYD and TYMS/ENOSF1 genes. The panel was derived from a meta-analysis of all published genes associated with 5-FU toxicity (n-4,855) and validated in 888 colorectal patients in the QUASAR 2 clinical data set.
ToxNav ® has 100% specificity for identification of people likely to die for 5FU/capecitabine toxicity. Grade 4 haematological toxicities are identified with a high degree of accuracy (98% specificity, 75% sensitivity, NPV 1, PPV 0.14). It Includes variants not found in other panels at a relatively low population frequency linked to severe (Grade 4) toxicities that may have fatal consequences. The risk of developing Hand Foot Syndrome is also uniquely included.
The ToxNav test comprises a simple blood test taken from the patient and sent to our laboratory. With a 2-week turnaround, the report stratifies patients into risk groups based on their individual genotype.
About Oxford Cancer Biomarkers
Oxford Cancer Biomarkers started as a spin off from the University of Oxford. The aim of the company was to discover and develop biomarkers using screening platforms to advance personalised medicine within oncology, specifically colorectal cancer.
Since then, the company has built a world class development team consisting of industry professionals, leading scientists and oncologists while maintaining strong links to the University Oxford. Together, we have launched our first product – ToxNav ® – and are positioned to launch OncoProg ® into the UK this year (2021). Our vision is to be the leading pioneer in biomarker technology products that places individual patients at the heart of cancer care.