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New MastaScope System Advances Cancer Detection
By Nicholas Borgert
Louis Keith, MD, PhD
Improved screening technologies and more accurate analyses are crucial weapons in the fight against breast cancer. Although highly curable when detected in the early stages, breast cancer cannot be diagnosed with a simple office-based test. Also, patients at high risk cannot be easily identified. Even more important, no technology or biomarker is available for regular use to reduce breast cancer mortality or morbidity.
The challenges to overcome are immense, as the latest statistics reveal.
A woman now living in the United States has a 1 in 8 chance of developing breast cancer sometime during her life. Many types of breast cancer differ in their tendency to spread (metastasize) to other body tissues. Treatment of breast cancer depends on the type and location of the breast cancer, as well as the age and health of the patient. The American Cancer Society reports that breast cancer is the second-leading cause of death in American women of all ages. For women age 25–55, it is the leading cause of death. The incidence of breast cancer has more than doubled in the last 30 years.
This year alone, 245,000 women in the United States will be newly diagnosed with breast cancer and ductal carcinoma in situ (DCIS). An additional 45,000 women will die from previously diagnosed and, in the vast majority of instances, previously treated breast cancer. The number of women at high risk for breast cancer is expected to nearly double over the next 20 years to approximately 15 million.
National Cancer Institute statistics indicate that 100 million mammograms are performed each year worldwide. Yet, clinical investigators have found breast cancer and premalignant breast lesions as small as 0.15 mm. Breast cancers typically begin at least 10 years before they can be detected by mammography.
Clinical evidence suggests that 85% of breast carcinomas originate in the epithelial lining of the mammary ducts, and a common sign is the presence of pathological nipple discharge. The use of fiberoptic ductoscopy (FDS) for patients with nipple discharge is an emerging technique that allows direct visual access to the ductal system of the breast through nipple-orifice exploration.
Funding from the National Cancer Institute continues to be concentrated on improvements in conventional mammography. Research has focused on refining the technology, improving the conditions under which it is administered, and bettering the interpretation of x-ray films. For breast cancer, the mammogram has been regarded as the best means of early detection. Mammograms, however, usually require a referral and a separate visit to a radiology center. Accuracy can be a problem, too: A mammogram can miss as many as 30% of breast cancers in patients.
Lifeline Biotechnologies, a Reno, Nevada-based diagnostics research and development company, is taking breast cancer detection in a new direction. The company’s most recent innovation, the MastaScope™, is a fiber optics-based system for detecting abnormalities that begin in the breast’s milk duct network.
The milk ducts are important because virtually all breast cancer originates from the small mammary milk ducts of the breast. There are early forms of breast cancer, such as DCIS, that cannot be detected by physical examination alone during their initial growth stages.
DCIS occurs in the lining of the milk ducts and is completely contained within the ducts. If DCIS is left untreated, however, it may over a period of years begin to invade the breast tissue surrounding the ducts and become invasive breast cancer. In addition, atypical hyperplasia, a potential marker for future development of breast cancer, may also be undetected by physical examination.
Louis Keith, MD, PhD, serves as senior medical consultant for Lifeline Biotechnologies. A professor of obstetrics and gynecology at Northwestern’s Feinberg School of Medicine, Keith is also emeritus senior attending physician in the Department of Obstetrics and Gynecology at Chicago’s Prentice Women's Hospital and Maternity Center.
According to Keith, practicing obstetricians/gynecologists have been frustrated with the lack of certainty and variations among results produced by conventional breast cancer diagnostic technologies. “Early detection of breast cancer is critical to treatment success and patient survival,” Keith says. Even the most modest changes in the detection of breast cancer can have enormous benefits to women throughout the United States.
The MastaScope works as a mini-laparoscope, employing fiber optics and imaging technologies. Keith says the MastaScope is used with a local anesthetic. It is not a tool for general breast cancer screenings of large populations, but rather a more specific tool used by physicians in response to earlier signs and symptoms, such as lumps under the nipples or an abnormal discharge from the milk ducts.
The new system uses an extremely small fiber optic scope and lens to look inside the milk ducts of the breast. The procedure allows a physician to view in real time (and save on tape digitally) any abnormalities (up to 60 times actual size) and monitor changes in the cell lining, which may indicate a malignancy or other problem. The procedure can be done by a physician in an office or clinic in about 30 minutes. After the anesthetic, the MastaScope is inserted into a pinpoint-sized hole in the nipple. No large incision that could damage healthy surrounding tissue in the breast is required. The surgeon examines the duct and, if necessary, takes a tissue sample or biopsy.
For those in the high-risk category, the MastaScope offers the ability to detect cancer at the earliest stages, enhancing the likelihood of survival and recovery. Many standard imaging platforms typically cannot detect a lesion until it is about 5 mm in size, and at that time, the disease may have already become more invasive and potentially lethal.
Keith says the MastaScope is totally different from other products, and fully complementary to traditional breast cancer screening procedures that include mammography. “The MastaScope can be used in the office, operating room, or anywhere to produce very small tissue samples for analysis by a lab.”
He says palpation—manual examination of the breast performed by a physician—continues as the most common screening tool for breast cancer in women. Yet it is far from being a precise method of screening. Palpation accuracy, he says, can depend on many factors, including the skill and experience of the examining physician, the size of the breast, and the size and location of any lumps.
“I have done thousands of these exams, and yet I’m not always sure what I’m feeling unless the mass is larger than one centimeter in diameter,” Keith says. “It’s not a perfect science. Doctors don’t have magic fingers for detecting lumps—especially lumps of less than one centimeter and lumps in large breasts.”
Keith says a comprehensive analysis of mammographies performed even since the adoption of national technical standards reveals broad variations. “It is absolutely amazing how different the results can be with regard to specificity and sensitivity. There is no unanimity of results. Conventional mammography can be expected to produce false positives in 15% to 30% of cases, depending on a variety of factors,” he says. Too many mammograms have become a source of frustration for patients and their physicians. “Patients want a procedure that can be done during their lunch hour and that will allow them to get a yes or no answer quickly.”
With each reduction in stages of breast cancer comes a decrease in suffering for the patient and a decrease in costs for treatment. The National Institutes of Health set the medical costs associated with treatment of late-stage breast cancer at more than $230,000 per patient.
Keith says he has been working with Lifeline President Bill Reeves for more than 20 years. “I discussed the MastaScope concept with colleagues in England, then went to London and watched a MastaScope prototype in action. One session in that OR and I was totally convinced. It presented an absolutely clear view of the interductal area,” he says. “It works.”
The basic MastaScope configuration features a scope with a tiny camera, a video coupler, and a sterilization tray. Available accessories include a mobile work center, a flat-panel monitor, a digital videocassette recorder with video pack, and a complete patient prep kit.
The scope captures real-time full-color images within the breast ducts, and the images can be digitally recorded and shared immediately with clinical laboratories and specialists anywhere in the world. In addition to imaging, the MastaScope is able to collect small amounts of cell scrapings and tissue samples that can then be forwarded to oncology labs for comprehensive analysis.
While the MastaScope has been limited to use by physicians in clinical settings, the results of the procedure offer clinical labs an important tool for breast cancer screening and diagnosis.
A physician using the MastaScope in an operating room or at the office can generate biopsy samples that can be retrieved by a laboratory for a thorough pathological analysis, a critical step for charting the best possible treatment regimen for a breast-cancer patient.
Nicholas Borgert is a contributing writer for Clinical Lab Products.
June 1, 2005
Posts: 170 | From: Quincy, MA, USA | Registered: Sep 2003
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Great article! It is not a PR? I just don't understand why they can't get the audit done in order to move to another exchange. Also, they have r/s this stock right down the toilet. Maybe now with the lower o/s it will turn around. Zero volume doesn't help either. Cowboy opinion only.
Posts: 105 | From: "Western", NY USA | Registered: Aug 2004
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Lifeline's MastaScope Featured In Full Page Article in Clinical Lab Products Magazine
Monday July 11, 11:04 am ET
RENO, Nev.--(BUSINESS WIRE)--July 11, 2005--Lifeline Biotechnologies, Inc. (OTCBB:LBTN - News) today announced that Louis Keith, MD, PhD, Lifeline's scientific director, was interviewed for a full page article on the company's activities in breast cancer screening and specifically its MastaScope(TM). The article appears in the June 2005 issue of Clinical Lab Products, which is the leading product news magazine for key decision-makers in the clinical diagnostic laboratory, reaching more than 45,000 key individuals. The article can be accessed at the magazine's website: www.clpmag.com/. The article, by Nicholas Borgert, focuses on the ability of the company's MastaScope product to help detect breast cancer at its earliest stages.
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.
-------------------------------------------------------------------------------- Contact: Martin E. Janis & Company, Inc. Bev Jedynak, 312-943-1100 ext. 12 bjedynak@janispr.com
Posts: 170 | From: Quincy, MA, USA | Registered: Sep 2003
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Lifeline Biotechnologies Announces Completion of Independent Audit for Fiscal 2003 and 2002 Business Wire - July 18, 2005 08:00
RENO, Nev., Jul 18, 2005 (BUSINESS WIRE) -- Lifeline Biotechnologies, Inc. (OTC:LBTN) today announced that the audited financial statements for fiscal 2003 and 2002 will be posted to the company's website and available for downloading. These statements, audited by Lopez, Blevins, Bork & Associates, LLP of Houston, Texas, reflect the company's financial condition at December 31, 2003 and 2002. Now that the 2003 and 2002 audit has been completed the 2004 audit is expected to be commenced within the next few weeks.
Jim Holmes, Acting CEO and Chairman of Lifeline, said: "This audit marks the beginning of a new era for Lifeline. Upon the completion of the 2004 audit we expect to file the appropriate filing with the SEC to become a reporting company." Holmes declined to state specifically when the 2004 audit will be available but noted that with the systems in place that have resulted in the 2003 and 2002 audits completion, "we do not anticipate any problems or the long delays previously experienced."
Holmes said that as expected, the company's audit contains "going concern" language. "As a company that is developing medical products that require regulatory approvals and market acceptance, there are losses that are incurred and the need to continually raise money during this phase of development. We strongly believe the research dollars and staff time we've incurred developing our First Warning System (FWS) and other product lines can result in life-saving benefits to women in the future."
Dr. Bill Reeves, developer of Lifeline's FWS, added, "I believe that we have taken a big step in the future growth of Lifeline. This audit is the first block in the building of a solid foundation to move forward."
In other matters, Holmes announced that Frank Clark, former Lifeline CEO, resigned his position due to health reasons. "Unfortunately Frank's health does not permit him to take the active role he had planned in Lifeline's business development. However, we are hopeful that his expertise can be provided to us as he is able in an informal consultant role."
Holmes also said that Jonathan Reeves, Lifeline's president, has resigned from the company to pursue other interests. "Jonathan provided strong support to Lifeline during the past years and we wish him continued success in his ventures." Holmes stated that the company will make an announcement in the near future as to future management.
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.Posts: 1872 | From: right here | Registered: Apr 2004
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quote:Originally posted by thinkmoney: Go LBTN! Let's have a run! Anyone think it ever will go up and run?
Yes, Once they finish the 2004 audit, move to another exchange and put someone competent at the helm now that the CEO and President have left the company..Cowboy opinion.
Posts: 105 | From: "Western", NY USA | Registered: Aug 2004
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posted
Every time this co. has a pr the price drops. Pretty soon it'll be back to a sub penny stock again (it's just about there now). This co. has the worst management people a co. could possibly have. They may have some smart people working on their products but their management team - forget it.
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Lifeline Biotechnologies Announces New Study from Professor Kefah Mokbel That Will Test Company's First Warning System and MastaScope Products Together for Assistance in the Detection of Breast Cancer Thursday August 11, 1:35 pm ET
RENO, Nev.--(BUSINESS WIRE)--Aug. 11, 2005--Lifeline Biotechnologies, Inc. (OTC:LBTN - News) today announced that Professor Kefah Mokbel, consultant breast surgeon at St. George's Hospital and Medical School and Professor at Brunel Institute of Cancer Genetics & Pharmacogenomics and his research team in the UK have commenced a new study, examining the role of mammary ductoscopy, using MastaScope, in conjunction with dynamic thermal analysis, using the First Warning System and proteomics in the early detection of breast cancer. This study has been approved by the Ethics' Committee at St. George's Hospital Medical School in London. Participants include patients with suspected breast cancer, patients with benign breast disease, healthy volunteers and women who are known to harbor breast cancer causing genes (BRCA-1 or BRCA-2). Professor Mokbel believes that these novel strategies for breast cancer detection will complement screening mammography, which is regarded as the gold standard screening tool. Furthermore, mammary ductoscopy, using the MastaScope, may complement the role of dynamic thermal analysis in cases where these tests are positive, but anatomical imaging is negative for malignancy. This potential application may help resolve the issue of false-positive results, associated with screening tools based on physiological and biological principles. Researchers hope that if the preliminary results of this study are successful that they can be presented in the fifth European Breast Cancer Conference in France early next year.
Lifeline Biotechnologies has been in the process developing the First Warning System for a number of years and already markets the MastaScope. "We look forward to the results of Professor Mokbel's study, as this is a major step in the commercialization and introduction to the market of our First Warning System," said Jim Holmes, chairman of Lifeline.
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.
-------------------------------------------------------------------------------- Contact: Martin E. Janis & Company, Inc. Bev Jedynak, 312-943-1100, Ext. 12 bjedynak@janispr.com
Posts: 170 | From: Quincy, MA, USA | Registered: Sep 2003
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