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
usually not diagnosed until advanced stages, it is called the “silent
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
the research group has begun a phase III evaluation, testing almost
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