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Lifeline's First Warning System Used in Peer-Reviewed Paper Published by International Seminars in Surgical Oncology: Abstract of This Paper Resulted in 400 Requests for Entire Clinical Paper in First Two Days Thursday April 21, 11:47 am ET Paper Comments on the Evolving Role of Dynamic Thermal Analysis in the Early Detection of Breast Cancer
FT. LAUDERDALE, Fla.--(BUSINESS WIRE)--April 21, 2005-- Lifeline Biotechnologies, Inc. (OTC:LBTN - News) today announced that a peer-reviewed article authored by Drs. M. Salhab, W. Al Sarakbi, K. Mokbel of St. George's and The Princess Grace Hospitals in London, UK, and Professor Kefah Mokbel, MS, FRCS, Professor at Brunel Institute of Cancer Genetics and Consultant Breast & Endocrine Surgeon at The Princess Grace Hospital, in London, has demonstrated that there is a future role for the use of dynamic thermal analysis in the early detection of breast cancer - particularly among young women with dense breast tissue. In a paper published this month by the International Seminars in Surgical Oncology, the authors outlined the potential of this technology, noting that cancer development appears to generate its own thermal signatures and the complexity of these signatures may be a reflection of its degree of development.
The article "focuses on dynamic thermal analysis as an evolving method in breast cancer detection in pre-menopausal women with dense breast tissue. Prospective multi-center trials are required to validate this promising modality in screening." The article also addresses an issue of false positives that require further investigation using molecular genetic markers of malignancy and novel techniques such as mammary ductoscopy.
"This article clearly states that thermal imaging could be a valid means for the early detection of breast cancer, particularly in those young women whose breast tissue is quite dense as well as those who have a family history of breast cancer," said Dr. William Reeves, founder of Lifeline and developer of the First Warning System(TM), which is a non-invasive system that monitors the minute temperature changes in a woman's breast and through proprietary algorithms to allow for early diagnosis of breast cancer. Lifeline believes it is the only company with this type of product under development.
According to the article, the First Warning System(TM) facilitates the recording of circadian rhythm variations of the breast and analyzes this data using highly complicated statistical software. A miniaturized microprocessor records and stores thermal information that is collected from eight separate sites of each breast by monitors that are affixed to the breast, much in the same way an electrocardiogram is used. "The sensors are placed in critical positions on the breast that have been determined as areas where cancers are most likely to develop," said Dr. Reeves.
In the First Warning System(TM), this thermal data is collected every five minutes over a 48-hour period. Some 9,000 pieces of data are recorded by microprocessors and analyzed. Temperature points from each sensor are plotted against each other to form a thermal motion picture of a lesion's physiological activity.
In its proof of concept study in 1989
Total number of open biopsies: 169 Characteristics of the biopsy population Mean age of biopsy population 44 yrs Age range of breast biopsy population 19 to 77 yrs Mean age of the breast cancer population 52 yrs Age range of breast cancer patients 35 to 72 yrs The average number of positive lymph nodes 1.17 Range 0 to 16 nodes Average tumor size 1.75 cms Range from microscopic to 4.5 cms
There were 32* Patients positive for breast cancer Cancers found by mammography 25** Cancers found by Lifeline's First Warning System(TM)(FWS): Neural net analysis 30*** Wavelet analysis 31 Wavelet/neural net analysis 32
* Four cancers in the series were eliminated from consideration by either statistical or neural network because of bad data. For the purposes of this study the adjusted number of cancers will is 32.
** Of the seven cancers missed by mammography, six were found by the FWS, all were under the age of fifty with tumors ranging in size from 0.5cms, to 3.5cm all in dense breast tissue. In addition two patients in the series had mammograms taken at another facility, therefore mammographic results were not available for the purposes of this study.
*** Four cancers produced a mirror image high-risk response in the opposite breast, which may be considered a paradoxical reaction, although the possibility of operator error might account for these findings. Since, four other cases with reversed reading results were discovered during the course of the study and were directly attributable to operator error on lead harness reversal.
The term "false positive" should be used with great caution since the monitor is designed to measure physiological data and not anatomical variations. Patients with a positive reading in the absence of mammographic or physical findings of cancer should be considered at "high risk" for the disease which may become clinically evident at some future date.
"We believe we have a very promising product in development and remain hopeful that upon completion of clinical development and future clinical trials, the First Warning System(TM) will be recognized as a safe, non invasive approach that is can help in the early detection of breast cancer - especially in young women where conventional mammography is of limited value. We believe that our First Warning System(TM) could become the initial breast screening tool for pre-menopausal women and those who are classified as positive can then be selected for anatomical imaging with mammography," Reeves said.
Lifeline Biotechnologies, Inc. is a company with innovative medical technologies committed to the improvement of the quality of life through exceptional health care systems. These technologies focus on prevention, early detection, diagnosis and quick recovery of a number of disease conditions. The company's Cancer Detection technologies deal with cutting edge innovation to assist practicing physicians in the delivery of quality medical care. The MastaScope(TM) is used in the early detection of cancer and other abnormalities of the breast. The MastaScope(TM) has completed development and has entered the marketplace in the US and internationally. The First Warning System(TM) for assisting in the early detection of breast cancer and the OvaScope(TM) for assisting in the early detection of ovarian cancer are continuing to be developed by the company. More information is available at the company's website: www.lbti.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In particular, when used in the preceding discussion, the words, "believe", "expects", "projects", "forecasts", "intends", "will", "anticipated", "could", or "may", and similar conditional expressions are intended to identify forward-looking statements within the meaning of the act and are subject to the safe harbor created by the act. Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements that involve a number of risks and uncertainties.
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