According to a recent study published in the journal Clinical Cancer Research, researchers at Yale School of Medicine have developed a very sensitive and specific blood test that is able to detect early stage ovarian cancer with 99 percent accuracy.
The research group, led by Professor Gil Mor of the Department of Obstetric, Gynecology, & Reproductive Sciences, had previously used four proteins in a blood test that detected cancer with 95 percent effectiveness. Mor says that “the ability to recognize almost 100 percent of new tumors will have a major impact on the high death rates of this cancer.” The researcher hopes that the test will become part of a woman’s routine examination.
The leading cause of gynecologic cancer deaths in the US, epithelial ovarian cancer is three times more deadly than breast cancer. Since it is usually not diagnosed until advanced stages, it is called the “silent killer.”
For this phase II clinical trial, 518 patients – 362 healthy controls and 156 with ovarian cancer – were analyzed by Mor and colleagues. The researchers first confirmed the previous research. One improvement noted for phase II was the use of a new platform called multiplex technology – very small amounts of blood serum are used in one single reaction. The multiplex technology utilizes six protein biomarkers instead of the four used previously. This increases the specificity of the test from 95 to 99.4 percent. The team determined if the proteins were present in the blood and then measured the amount of each protein. Test results were assessed independently by the Early Detection Research Network (EDRN) of the National Cancer Institute (NCI).
Professor Mor indicates that no other test is as sensitive or specific as this one. “Previous tests recognized 15 to 20 percent of new tumors. Proteins from the tumors were the only biomarkers used to test for ovarian cancer. That is okay when you have big masses of tumors, but it is not applicable in very early phases of the tumor. Testing the proteins produced by the body in response to the presence of the tumor as well as the proteins the tumors produce, helped us to create a unique picture that can detect early ovarian cancer,” states Mor.
Currently, Yale offers the test through the Discovery to Cure program. Laboratories Corporation of America in the United States, Teva in Israel and SurExam in China also have licenses for the test. With EDRN/NCI and LabCorp, the research group has begun a phase III evaluation, testing almost 2,000 patients.
Diagnostic Markers for Early Detection of Ovarian Cancer
Irene Visintin, Ziding Feng, Gary Longton, David C. Ward, Ayesha B. Alvero, Yinglei Lai, Jeannette Tenthorey, Aliza Leiser, RubenFlores-Saaib, Herbert Yu, Masoud Azori, Thomas Rutherford, Peter E. Schwartz, and Gil Mor
Clinical Cancer Research, 14 (4). pp. 1065-1072. February 15, 2008
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Written by: Peter M Crosta