Mar 6 2006
Phoenix-based Biomarker Technologies announced the launch of a clinical study for its revolutionary blood test that detects breast cancer. Previous clinical studies have shown the test to significantly exceed the accuracy of mammograms.
The upcoming 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 a first-of-its-kind blood diagnostic that detects the presence of breast cancer at the molecular level.
"We expect the results of this clinical study to demonstrate an even higher level of accuracy than either film or digital mammography," said William Gartner, CEO and President of Biomarker Technologies. "With this greatly improved diagnostic accuracy, the BT Test will ultimately become a critical tool in detecting breast cancer without the discomfort and inconvenience of a mammogram."
The study will involve 430 women referred for biopsy, 125 women referred for other types of cancer, and 300 healthy subjects. The study is expected to take four months to complete, with the collection of blood samples beginning in early March 2006.
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. Gartner said that the BT test can provide higher sensitivity, a broader range of age applicability, and ease of administration and patient convenience while greatly increasing the number of early detections.
"This clinical study will move the BT Test forward in its FDA approval as first a supplementary and then a stand-alone screening tool for early breast cancer detection," said Gartner. "With fewer false negative and false positive diagnoses, this cost-effective blood test may not only offer vastly superior early-detection capabilities in routine examinations, but may also help patients avoid unnecessary needle biopsies."
The study will also examine using the BT Test together with the Riboflavin Carrier Protein biomarker from RCP Diagnostics LLC, which may enhance the sensitivity of the BT Test beyond the expected level of accuracy.