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Power3 Medical Products, Inc. said today that two CIP patent applications have been filed for BC-SeraPro Breast Cancer blood test and biomarkers by Dr. Ira Goldknopf, its president and Chief Scientific Officer.
The applications for utility patents are entitled “Identities, Specificities, and Use of Twenty Two (22) Differentially Expressed Protein Biomarkers for Blood Based Diagnosis of Breast Cancer,” and “Isoform Specificities of Blood Serum Proteins and their Use as Differentially Expressed Protein Biomarkers for Diagnosis of Breast Cancer.” The applications are both Continuations in Part (CIP) of a U.S. utility patent application filed on December 7, 2006, involving 12 blood serum protein biomarkers.
Dr. Goldknopf said Power3 Medical’s BC-SeraPro is the first blood serum test available for breast cancer, with an ongoing 100 patient validation study currently in progress.
200,000 Breast Cancer Cases, 40,000 Deaths Each Year
“There is an urgent need to detect breast cancer in its earliest stages … a need that is not being met by the current standard of care and tests,” said Dr. Goldknopf. “In the U.S., alone,” he said, “more than 200,000 women are diagnosed each year, and more than 40,000 women die because diagnosis is often late — years late — by which time the disease has progressed, decreasing the likelihood of survival.”
He said a recent study of current diagnostic standards showed mammography and physical examinations detected only 17-33% of breast cancers diagnosed within three years of the initial examination. Dr. Goldknopf said that the study showed one-third of the cancers were missed, and 75 percent of the biopsies of suspected cancer proved to be unnecessary, costing the healthcare system $2.1 billion annually.
“When women are found to have breast cancer ’susceptibility genes’,” he said, “this only indicates their increased risk of getting breast cancer, not that they actually have it. This exposes the physician and the patient to difficult decisions ‘in the dark’, which are fraught with peril, including prophylactic mastectomy, chemoprevention, or a “wait-and-see” approach. MRI’s are more sensitive, and can detect up to 80 percent of breast cancers, but with significantly increased false positives and substantial increased expense, rendering them impractical for standard screening.”
Accurate Early-Detection Screening
“What women and doctors need is an accurate early-detection screening test to fill the deficits of current technology,” Dr. Goldknopf said. “That is our goal for Power3’s BC-SeraPro blood test and our patent applications, which are based on the results from more than 750 patient and control blood serum samples.”
Dr. Goldknopf said the intellectual property in the patent application consists of 22 identified protein biomarkers showing “statistically significant disease-specific abnormal concentrations in blood serum of breast cancer patients.”
The abnormal blood protein differences gave high levels of sensitivity and specificity,” he said, noting that, “the intellectual property as disclosed in the latest two patent applications also extends to an unexpected extra finding that the blood test can distinguish between invasive breast cancer and the earlier, harder-to-detect ductal carcinoma in situ (DCIS), which has a different abnormal blood serum protein expression profile than invasive breast carcinoma.”
“To detect DCIS is a substantially value-added benefit for women, as it can provide better guidance in deciding whether to have a lumpectomy or a mastectomy,” said Helen R. Park, Power3’s interim CEO. “A personal friend recently went through this,” she said, “and probably could have avoided chemotherapy if a mastectomy had been performed the first time.”
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