Matritech seeks expanded approval for cancer test:
This article was originally published in Clinica
Matritech is seeking to expand US approval for its NMP22 bladder cancer test to include initial detection of the disease. The test is currently approved by the FDA for the management of patients already diagnosed with bladder cancer, although the Japanese government has authorised reimbursement for its use in cancer screening. The Newton, Massachusetts-based company has submitted results of a clinical study involving 1,147 subjects to the FDA, which found that the test had 85% sensitivity in detecting late stage bladder cancer, in high-risk but previously undiagnosed patients. Overall sensitivity to all forms of bladder cancer was 70%.