Power3 Medical Products (The Woodlands, Texas) said it has discovered a group of breast cancer protein bio-markers in preliminary studies of blood serum, and the company's hope is that it will lead to an early screening test for breast cancer that could be developed based on the discovery as a replacement for mammography.

By monitoring the blood serum concentrations of those proteins and then subjecting the results to biostatistical analysis, Power3 scientists believe they will be able to use these biomarkers to discriminate between three groups of women: women with breast cancer, women with benign breast disease and normal women with no detectable breast cancer.

"We are very, very optimistic," Chairman and CEO Steven Rash told Diagnostics & Imaging Week.

However, he said that the company must be "very discreet in what we say because we're in the process of filing [for] patent protection." Rash said that thus far, Power3, which was formed in 1992 but has only been in the "proteomics arena" since 2004, has filed for 22 patents and received one.

"But remember, we're a young company, and it takes years for these patents to be approved, especially in proteomics and biochemistry, which are rather complex," he said.

The total number of breast cancer patient and control blood serum samples under study in the Power3 laboratory includes more than 500 retrospective and prospective samples, the company said. Of those, 151 prospective samples are from patients enrolled in a breast cancer clinical validation study being conducted by Power3, comprising "a categories of normal, benign and cancer samples, from women at three clinical sites – Mercy Women's Center (Oklahoma City); Obestetrical and Gynecology Associates (Houston); and NYU School of Medicine (New York).

The initial study was performed with samples from 76 women. The results were then subjected to biostatistical analysis.

"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 Dr. Ira Goldknopf, chief scientific officer at Power3.

Goldknopf said the company would be adding more women to the study, and there really was no way to say how long they might continue.

The company said that any diagnostic test that may ultimately be developed from the biomarkers "may have utility with high-risk women and possible the general population of women as well."

Dr. Alan Hollingsworth, principal investigator at Mercy Women's Hospital, said, "Two basic problems keep mammography from being the ultimate answer for early detection. First, mammograms mist cancers far more often than is generally appreciated; secondly, even when diagnosed by mammography, some cancers have already spread, such that so-called 'early diagnosis' is not early enough."

Hollingsworth said that the hope is that a diagnostic test based on the biomarkers could show whether a patient has breast cancer "years prior to mammography, indicating the need for more aggressive imaging with ultrasound or MRI."

In addition to breast cancer biomarkers, Power3's other focus is on biomarkers for neurodegenerative diseases, including Alzheimer's and Parkinson's diseases.

Rash's business plan is to license the technology for diagnostic purposes to large diagnostic companies and then license those same biomarkers to drug companies as drug targets.

He told D&IW, "If we [get] one of our neurodegenerative tests approved for home-brew, we might have [a test] available in the next few months. We're optimistic, and if we have the right strategic partner we can really accelerate the commercialization of the technology."

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