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FDA Approves 2 Diagnostic Tests, Acts on Eulexin Application

FDA Approves 2 Diagnostic Tests, Acts on Eulexin Application

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.

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