A Diagnostics & Imaging Week

Power3 Medical Products (Houston) said that two Continuations in Part (CIP) patent applications have been filed for BC-SeraPro Breast Cancer blood test and biomarkers by Ira Goldknopf, its president and chief scientific officer.

The applications for utility patents are titled "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 CIPs of a U.S. utility patent application filed on Dec. 7, 2006, involving 12 blood serum protein biomarkers.

Goldknopf said Power3's BC-SeraPro is the first blood serum test available for breast cancer, with an ongoing 100 patient validation study currently in progress.

"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," he said "In the U.S., alone, 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."

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."

Power3 is a biomedical company engaged in the commercialization of cancer and neurodegenerative disease biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets.

In other patent news:

• Imaging Diagnostic Systems (Fort Lauderdale, Florida) said it has been awarded its 21st U.S. patent, "Apparatus and Method for Acquiring Time-Resolved Measurements Utilizing Direct Digitization of the Temporal Point Spread Function of the Detected Light."

This invention, conceived by Steven Ponder, PhD, director of advanced development, and Robert Wake, VP of engineering, covers a key technology for time-resolved optical imaging which improves the quality of the imaging data and decreases the time required to acquire the image data, the company said.

The invention exploits a long-established trend in integrated circuit evolution to advance the acquisition of time-resolved image data for optical imaging of human and animal subjects, the company said.

"Time-resolved CTLM imaging of the breast can provide quantitative information that may be used to discriminate between malignant and benign lesions. However, the technique is inherently more time consuming than our standard continuous wave Computed Tomography Laser Mammography (CTLM) scanning method, and it requires sophisticated and expensive circuitry to make accurate measurements of the very short pulses of light used in time-resolved imaging. This invention exploits recent advances in the speed of digital acquisition components in order to reduce the cost and complexity of time-resolved measurement systems," Ponder said.

The invention also will reduce the costs of what has been an otherwise prohibitively expensive technology, namely efficient time-resolved optical imaging, whether computed tomography or topography, the company noted.

Imaging Diagnostic Systems has developed an imaging device to aid in the detection and management of breast cancer. The CTLM system is a new breast imaging system that uses laser technology and algorithms to create 3-D images of the breast. According to the company, the procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CTLM should be used in conjunction with mammography in detecting breast cancer in the dense-breast patient population, which is not commonly detected with mammography alone.

Imaging Diagnostic Systems said it is collecting data from clinical sites for the future filing of an FDA pre-market approval application for the CTLM system to be used as an adjunct to mammography.