Blood Test and Cancer
Clinical
Study Of Blood Test To Diagnose Breast Cancer, Biomarker
Technologies
Phoenix-based
Biomarker Technologies has received their certificate of
approval from Western IRB to begin their clinical study
on the early detection of breast cancer using a blood diagnostic
test called the BT Test(TM). The study actually began with
the first subject signup and blood collection on April 21,
2006.
The
study will examine women's blood for a number of cancer
related biomarkers, which are specific proteins having concentrations
that are measurably different in patients with breast cancer.
The BT Test is the first blood diagnostic that detects the
presence of breast cancer at the molecular level.
Study
enrollment will be coordinated at several Phoenix-area clinics
and imaging centers that will enroll women who are referred
for either screening mammograms or breast biopsies. BenOra
Imaging will invite participation by women undergoing screening
procedures, while biopsy referrals will be enrolled at BenOra
Imaging, Breast Net, Scottsdale Medical Imaging's Mountain
View and Town Center locations and by Dr. Christa Corn.
In all, more than 20 Phoenix-based physicians are expected
to participate in the study by referring patients and providing
clinical oversight. Their efforts are lead by Dr. Linda
Dinquel of BenOra Imaging; Dr. Belinda Barclay-White, the
founder of Arizona Breast Net; Dr. Connie Jones at Scottsdale
Medical Imaging Ltd; and Dr. Christa Corn. Kronos Science
Laboratories, a certified CLIA laboratory in Phoenix, will
be performing the sample analysis for the study.
The
study will involve more than 930 women, approximately 505
referred for biopsy, 125 referred for other types of cancer
and 300 healthy subjects. The study is expected to take
four to six months to complete.
The
study will also examine using the BT Test together with
a new protein biomarker test from RCP Diagnostics LLC, a
sister company to Biomarker Technologies. The marker, called
Riboflavin Carrier Protein, or RCP, may enhance the sensitivity
of the BT Test beyond the expected high level of accuracy.
It is projected that the BT Test, perhaps in conjunction
with the RCP marker, will significantly improve on the 74
to 80% accuracy of mammograms.
The
American Cancer Society estimates that only 50% of the women
who should have annual mammograms actually do so. Whether
this is due to the embarrassment, discomfort or time required,
is not fully known. However, surveys have shown that substituting
the collection of a blood sample for a mammogram would greatly
increase the annual breast testing rate for women over 40.
Breast Cancer is the leading cause of cancer in women, and
studies have shown that early detection leads to a 97 percent,
five-year survival rate. Still, more than 40,000 women die
from Breast Cancer each year in the U.S. alone with more
than 400,000 deaths worldwide. Higher participation in annual
screening could dramatically drop the death rate.
William
Gartner, President and CEO of Biomarker Technologies said,
"The BT Test can provide higher sensitivity, a broader
range of age applicability, ease of administration and patient
convenience, while greatly increasing the number of early
detections. This could save thousands of lives every year."
About
Biomarker Technologies
Arizona-based
Biomarker Technologies LLC is a translational in-vitro diagnostic
company focused on the diagnosis of breast cancer. The company
is poised to quickly bring the BT Test to market either
by licensing the test to a large global provider or through
FDA's ASR Reference Lab Program.
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medicalnews.php?newsid=42551.