“The ability to recognize almost 100 percent
of new tumors will have a major impact on
the high death rates of this cancer,” said
Mor. “We hope this test will become the
standard of care for women having routine
examinations.”
Epithelial ovarian cancer is the leading
cause of gynecologic cancer deaths in the
United States and three times more lethal
than breast cancer. It is usually not
diagnosed until its advanced stages and has
come to be known as the “silent killer.”
This new phase II clinical trial led by Gil
Mor, M.D., associate professor in the
Department of Obstetrics, Gynecology &
Reproductive Sciences at Yale, included 500
patients; 350 healthy controls and 150
ovarian cancer patients.
Mor and colleagues validated the previous
research and used a new platform called
multiplex technology to simplify the test
into one single reaction using very small
amounts of serum from the blood.
The new platform uses six protein biomarkers
instead of four, increasing the specificity
of the test from 95 to 99.4 percent. The
team looked for the presence of specific
proteins and quantified the concentration of
those proteins in the blood.
The Early Detection Research Network (EDRN)
of the National Cancer Institute (NCI)
independently evaluated the results of the
test.
“This is the most sensitive and specific
test currently available,” said Mor.
“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.”
Mor and colleagues have begun a phase III
evaluation in a multi-center clinical trial.
In collaboration with EDRN/NCI and
Laboratories Corporation of America (LabCorp),
they are testing close to 2,000 patients.
The test is available at Yale through the
Discovery to Cure program. Yale has licensed
the test to three companies: Lab Corp in the
United States, Teva in Israel and SurExam in
China.
###
Other authors on the study included Irene
Visintin, Ziding Feng, Gary Longton, David
C.Ward, Ayesha B. Alvero, Yinglei Lai,
Jeannette Tenthorey, Aliza Leiser, Ruben
Flores-Saaib, Herbert Yu, Masoud Azodi,
Thomas Rutherford and Peter E. Schwartz.
