ROCKVILLE, Md--In recent actions, the FDA approved two new diagnostic tests--for bladder cancer and colorectal cancer--and extended the indications for an antiandrogen agent in the treatment of prostate cancer.
The agency gave final approval for Matritech's NMP22 Test Kit for use in identifying patients at risk for bladder cancer recurrence. The kit is the first nuclear matrix protein (NMP)-based diagnostic product to receive FDA clearance.
The test kit, a urine assay for transitional cell carcinoma of the urinary tract, which accounts for more than 95% of all bladder cancers, has been found in clinical trials to be twice as sensitive as urine cytology, the company said, and has the added benefit of delaying and reducing the number of cystoscopies needed in follow-up care for patients at risk.
Said Daniel B. Rukstalis, MD, of the Medical College of Pennsylvania, who participated in the NMP22 trials, "a low NMP22 value 10 days after surgery enables near-90% certainty that my patient will not have a malignancy at 3-month follow-up cystoscopy." Conversely, he said, an elevated value gives a high degree of certainty that the patient likely will have a recurrence at the 3-month follow-up, "which enables me to react quickly, thereby improving the prognosis."
CEA-Scan Imaging for Colon Ca
Immunomedics, Inc. has received clearance to market CEA-Scan (Arcitum-omab), a diagnostic imaging product for colorectal cancer. The CEA-Scan is the first technetium-labeled antibody and the first small antibody fragment licensed for diagnostic imaging in the United States.
The assay is to be used in conjunction with standard diagnostic methods, including CT scan, as a means of detecting the presence, location, and extent of recurrent and/or metastatic colorectal cancer in the abdominopelvic region. The product provides additional information in patients with no evidence of disease by standard diagnostic methods, and in whom there is a suspicion of cancer recurrence or spread.