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Blood Test that Beat Mammogram at Finding Breast Cancer Moves Forward

BT Test ready to start new clinical trials this month to prove early detection system

March 3, 2006 – The BT Test, a revolutionary blood test that in previous clinical studies has shown to significantly exceed the accuracy of mammograms in detecting breast cancer, is ready to launch additional clinical trials in March, according to an announcement by Biomarker Technologies. It is hopeful news for senior citizens, since breast cancer risk increases with age. It is the leading cause of cancer in women, and studies have shown that early detection leads to a 97 percent, five-year survival rate.

 

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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.

 

About Breast Cancer Risk

 
 

  ● The National Cancer Institute estimates that, based on current rates, 13.2 percent of women born today will be diagnosed with breast cancer at some time in their lives.
  ● Because rates of breast cancer increase with age, estimates of risk at specific ages are more meaningful than estimates of lifetime risk.
  ● An estimated risk represents the average risk for all women in the United States as a group. This estimate does not indicate the risk for an individual woman because of individual differences in age, family history, reproductive history, race/ethnicity, and other factors.
  ● Estimated lifetime risk of breast cancer has gone up gradually over the past several decades. This year it declined slightly

A woman’s chance of being diagnosed with breast cancer is:

  ● from age 30 through age 39 = 0.44 percent (often expressed as “1 in 229”)
  ● from age 40 through age 49 = 1.46 percent (often expressed as “1 in 68”)
  ● from age 50 through age 59 = 2.73 percent (often expressed as “1 in 37”)
  ● from age 60 through age 69 = 3.82 percent (often expressed as “1 in 26”)
More at National Cancer Institute - Click

 

 

The study is expected to take four months to complete, with the collection of blood samples beginning in early March 2006.

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.

For more information on BT Test, please visit www.biomarkertech.com or contact Biomarker Technologies at 602-468-0067.

About Biomarker Technologies
Arizona-based Biomarker Technologies LLC (www.biomarkertech.com) 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.

Source: Biomarker Technologies

 

 

 

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