NEW YORK (GenomeWeb) – MDx Health has launched its planned bladder cancer test, a liquid biopsy assay that analyzes methylation in three genes — TWIST1, ONECUT2, and OTX1 — along with mutations in three others.
Like the firm’s existing prostate cancer test, ConfirmMDx, the new AssureMDx bladder test is designed to help physicians pick out patients who have a low-risk of having cancer and thus can avoid more invasive tests.
In the bladder cancer setting, patients diagnosed with hematuria, or blood in the urine, are traditionally followed with cystoscopy, which can be relatively invasive, not to mention prone to missing certain cancers.
The company estimates that less than a third of individuals who show up to their doctor with hematuria go on to be diagnosed with bladder cancer, suggesting that two thirds are receiving diagnostic procedures that are unnecessary. MDxHealth’s test is intended to help rule out the presence of cancer non-invasively, sparing those patients who test negative from cystoscopies.
According to a multicenter validation of the test published earlier this year, the new assay boasts a 99 percent negative predictive value (NPV).
More specifically, assuming a bladder cancer prevalence rate of about five percent in patients with hematuria, the