Biomarker Technologies (BT; Phoenix) has launched a clinical study for its blood test that it says detects breast cancer, which if approved, would be the first for this purpose, it said.

According to the company, previous clinical studies have shown the test to “significantly exceed“ the accuracy of mammograms, which are widely believed to be less than perfect at detecting cancer, particularly in dense breast tissue.

“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.“

Gartner told Medical Device Daily that previous studies of the blood test have shown accuracy at 88%, compared to film mammography, which of the many studies that have been completed and published on this subject, the highest accuracy is at 80%.

Digital mammography has an accuracy rate of about 74%, he said.

“In [this] second study, because we're using live subjects instead of frozen serum, we expect the accuracy to grow dramatically,“ he said, adding that he expects the accuracy to be in the “90s.“

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 having begun in early March.

The company said breast cancer is the leading cause of cancer in women, and studies have shown that early detection leads to a 97% five-year survival rate. The company expects that the BT test will provide “higher sensitivity, a broader range of age applicability, and ease of administration and patient convenience while greatly increasing the number of early detections.“

“The 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 . . . test may not only offer vastly superior early detection capabilities in routine examinations, but may also help patients avoid unnecessary needle biopsies.“

The study also will examine using the BT test together with the Riboflavin Carrier Protein biomarker from RCP Diagnostics (also Phoenix), which may enhance the sensitivity of the BT test beyond the expected level of accuracy.

Since Biomarker Technologies is a licensing company, its goal is to license the technology to a number of companies.

Gartner told MDD that the company is already in negotiations with “the largest diagnostics company in Japan and a very large one in China.“

The company is also in negotiations with U.S. companies, he said.

Other companies are pursuing similar blood tests to detect breast cancer. Last week, ExonHit Therapeutics (Marcy l'Etoile, France), a drug and diagnostic discovery company, and bioM rieux (Paris), a developer of in vitro diagnostics, reported reaching a research milestone in the diagnosis of blood cancer.

The companies said that data to be presented tomorrow at the 97th annual meeting of the American Association for Cancer Research (Philadelphia) in Washington is expected to lead to the development of tests that will enable early detection of breast cancer from blood.

According to the companies, the data shows that the panel of genetic signatures identified by ExonHit can distinguish healthy women from those with early-stage breast cancer (MDD, March 31, 2006).

Last August, Power3 Medical Products (The Woodlands, Texas) said it had discovered a group of breast cancer protein biomarkers in preliminary studies of blood serum. It has a similar hope for its test, i.e., to replace mammography (MDD, Aug. 29, 2005).

The company said the total number of breast cancer patients and control blood samples in its study as of August was more than 500, and it planned to add more.

“Of 76 samples used in the construction of the initial statistical model, all 18 normal women were correctly scored as normal, 32 of 33 women with breast cancer scored as having breast cancer and one scored as benign, and 23 of 25 women with benign breast disease scored as benign and two scored as having breast disease,“ said Ira Goldknopf, chief scientific oficer, at the time.