Matritech's cancer assay gets positive panel review
This article was originally published in Clinica
Executive Summary
The US FDA's Immunology Devices Advisory Panel voted four to three on November 30th in favour of recommending that Matritech's NMP22 assay be approved after additional data in women and blacks is accrued. The NMP22 test kit is an immunoassay for quantitative determination of the level of nuclear protein NMP22 in the urine of patients recently treated for transitional cell bladder cancer. Matritech is developing the MAb kit to aid in the identification of patients at risk for recurrent bladder cancer.