The need for a simple, accurate screen for ovarian cancer, one of the leading causes of cancer death among women, is critical. Ovarian cancer is difficult to detect and often missed in its early stages due to subtle and non-specific symptoms that can be confused with those of other non-cancerous conditions. Although there are some laboratory tests that can help to diagnose and monitor ovarian cancer, such as CA-125, scientists are still trying to find a specific, reliable method for screening asymptomatic women.

Over the last several months, there has been a great deal of excitement and discussion related to a new test that has been hailed as such a screening tool. Named OvaCheck(TM), this test uses a methodology called low-molecular-weight serum protein pattern recognition. It is based on the discovery that certain diseases, like ovarian cancer, are associated with a distinct protein pattern or “signature” that can help in their detection.

The test, which was developed by Correlogic Systems, Inc. is based on technology developed jointly by the National Cancer Institute and the Food & Drug Administration (FDA). It can be run on a patient’s blood sample taken from a fingerstick. According to its manufacturer, OvaCheck is far more sensitive for detecting stage I (early) cancer than the CA-125 test.

Despite this promising finding, many health professionals still have concerns. They would like to see more published results of the test’s accuracy, and the labs that will perform the OvaCheck analyses still need to complete their own validation studies. Consequently, despite the recent attention given to the OvaCheck test, it will still be some time before it becomes available.

Update 8/30/04:
The FDA recently decided that the software used with the OvaCheck test classifies as a medical device and therefore is subject to its premarket review process. As a result, it will still be some time before OvaCheck becomes available. In the meantime, Correlogic is working with the FDA to find a solution to these regulatory issues.

Print Sources:
Auxter-Parham, Sue. Serum Protein Pattern Recognition in Disease Diagnosis: Is It Ready for Use in Ovarian Cancer Detection? Clinical Laboratory Strategies, April 2004

Letter from Peter Levine, President and CEO of Correlogic Systems, Inc. to Steven Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Food and Drug Administration. July 14, 2004.