New Data Confirms CSATM Blood Test Detects
Early-Stage Cervical Cancer, December, 2003, Gynecologic
Oncology
Winston-Salem, North Carolina (January 17, 2004) – Onconix
(previously Cervius), Inc., reported today the publication of an article
entitled “Circulating levels of insulin-like growth factor-II and
IGF-binding protein 3 in cervical cancer” in the scientific journal Gynecologic Oncology. The article, authored by Dr. Subbi Mathur
and her colleagues at the Medical University of South Carolina (Charleston,
SC), is the most recent of several peer-reviewed
publications that demonstrate that the CSA blood test can accurately detect
very early stages of cervical cancer and monitor therapy.
This current publication and earlier work indicates
that the CSATM test, which measures a specific protein in blood,
is elevated in all cervical cancer patients and most women with
pre-cancerous cervical conditions compared to normal women – and initial
studies suggest that the CSATM test is not elevated in other
cancer types and other clinical conditions.
The blood test could be used for both screening for cervical cancer
and monitoring patients who already have cervical cancer.
Commenting on the potential of the test, Eric Button,
Chairman of Onconix (previously Cervius) and former manager of the PSA
prostate cancer test at Hybritech (San Diego, CA), said: “The clinical data
reminds me of the data I saw early on with the PSA test, and like the PSA
test which is only significantly elevated in prostate cancer, the CSATM
test only appears to be elevated in cervical cancer. This test may have the same potential for
women for cervical cancer as the PSA test did to detect prostate cancer in
men. In fact, the CSATM
test may be able to detect aggressive forms of cancer as well as
pre-cancerous conditions – something the PSA test cannot do.”
In spite of the recommendation for annual Pap smear
screening, cervical cancer remains a major gynecologic malignancy and
claims 14,500 new cases and 4,800 lives every year in the U.S., and it has been estimated that at least 25% of women
with high-grade cancer are not being identified by routine Pap smear
examinations. The CSATM
blood test may not only be able to identify these women but also offer the
convenience of a blood test.
Approximately 45 million Pap smears are performed annually in the U.S.
The CSA test has drawn worldwide interest since the
first announcement made by Onconix (previously Cervius) of the test. Onconix (previously Cervius) will
initially make the test commercially available through major clinical
diagnostic laboratories. Onconix
(previously Cervius) will finalize its first relationship with a major
clinical reference laboratory by the end of the first quarter of 2004, and
is in the process of seeking additional collaborations.
About Onconix
(previously Cervius)
Onconix (previously Cervius), a privately held
biotechnology company, based in the Piedmont Triad Research Park in
Winston-Salem, NC, has obtained an exclusive license to the CSA
blood test from Bio-White Diagnostics, LLC (Columbia, SC) and the Medical
University of South Carolina (Charleston, SC). The CSA cervical cancer test
has proven effective in patient studies as a blood based test for screening
large populations as well as an aid in monitoring treatment efficacy and
metastasis. The Pap smear is currently the primary test for screening women
for cervical cancer and its pre-cancerous stages, cervical epithelial neoplasia
(CIN). Unfortunately, Pap smear tests may either yield equivocal results or
are simply unavailable. In many
countries, cultural taboos prevent women from undergoing tissue sample
collection. Onconix (previously
Cervius) has developed a highly accurate but simple blood test that should
prove to be more convenient.
