February 15, 2007
Iris Molecular Diagnostics, a subsidiary of Iris International Inc, has filed a 510(k) application with the FDA for its ultra-sensitive Prostate-Specific Antigen (PSA) test.
The Nucleic Acid Detection Immuno Assay (NADIA) PSA is designed for monitoring prostate cancer patients following therapy.
The assay detects proteins using nucleic acid labeled antibodies and the polymerase chain reaction and can be performed on instruments already in place in large laboratories.
NADIA platform technology is also being used to develop an HIV viral load test to monitor the residual amounts of HIV in patients’ blood and a test for monitoring breast cancer following a mastectomy or lumpectomy.
More information can be found on the company’s Web site.
