Clinical Study Of Blood Test To Diagnose Breast Cancer, Biomarker Technologies

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 02 May 2006 - 0:00 PDT

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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.

Biomarker Technologies
http://www.BiomarkerTech.com

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