Products in Development: Breast Check Devices
Overview
Breast cancer continues to be the leading cause of cancer related death in women between the ages of 35 and 54. Breast check devices are the most recent products introduced to physicians and patients for detecting this dreaded disease.
Diagnosis
Currently patients and physicians use palpation and eyesight to detect tumors in the breast. Some patients and physicians are more skilled and thorough in performing the exam than others. Unfortunately some lesions are not detected until they are well advanced, and other times not at all.
Although some malignancies are being detected at an earlier more treatable stage, patients discover up to 70% of all breast malignancies at lump sizes between 2.4 and 3.6 cm in diameter. Most malignancies greater than 1.5 cm in diameter have associated lymph node involvement and disease metastasis. Women who practice regular breast self examinations (BSE) find lumps earlier on in the disease process (average 1.3 cm) than women who do not practice regular BSE (average 3.8 cm).
Patient Population
The target market for breast check devices includes women over 50 who receive annual mammograms but are at high risk and thus need an intermittent diagnostic tool, as well as for women under 50 who do not receive regular mammograms. The device could be especially useful for women under 50 because their breast tissue is denser, which makes it more difficult for mammography to identify suspicious lesions.
Market Drivers
The market drivers are all the trends, issues, economic factors, and measurement trends that are pushing the market to greater growth. Market drivers for the breast check market include the following:
· Increased awareness of breast cancer
· Increase in detection of early stage breast disease
· Potential to serve as an additional tool in diagnostic work-up routine
· Potential to become an additional insurance toolagainst malpractice (Breast cancer is the secondmost common cause of medical malpractice,constituting 38% of all cancer malpractice awards).
Market Restraints
The market restraints are the trends, issues, economic factors, and measurement trends that limit market growth. Market restraints are as follows:
· Some practitioners find the current test, approximately 15 minutes, too time consuming
· No clinical data available
· Not reimbursed
· Not all potential patients visit the doctor on aregular basis or self-administer breast exams.
· Consumers might find the test difficult to administer and be fearful of results.
Market Potential
There are approximately 90 million women over 20 who are candidates for this diagnostic tool. If proven easy to use and efficacious, the product would appeal to patients and gynecologists alike. Assuming an average selling price of $25 and an average use of approximately one unit per year per patient, the potential market is approximately $2.2 billion. However there are several barriers that need to be overcome to achieve significant market penetration.
Product Offerings
Currently there is one product available on the market and one product in development.
HumaScan
Distributed by Physician Sales & Service, HumaScan launched BreastAlert in January 1998. The device consists of a pair of mirror-image, non-invasive, disposable soft pads, each of which has conductive foil sensors which record skin temperature variations.
Metabolic activity in the breast increases as breast cancer progresses. Because BreastAlert detects temperature differentials at the surface between three regions of each breast, physicians discover any areas which warrant further examination. The test takes approximately 15 minutes.
HumaScan has commenced post-marketing clinical trials to provide additional clinical data on the products' ability to detect breast disease. The company is hoping to prove BreastAlert can identify lesions smaller than 10 mm. A woman doing a breast self exam can identify lesions in the 20 mm and higher range, while the physician can detect lesions greater than 15 mm.
HumaScan markets BreastAlert to gynecologists, primary care physicians, nurse practitioners and other medical specialists.
Assurance Medical
Assurance Medical, a division of UroMed, is currently undergoing the PMA route within the FDA for BreastCheck, a device that utilizes miniature pressure sensors to electronically palpate the breast. The pressure data is then analyze by computer algorithms to detect presence of a lump. The sensors are more sensitive than the nerves in the finger and cover a much larger area than the fingertips at any given time. The company is also developing BreastExam, a device similar to BreastCheck but designed for physician use.
Clinical trials are near completion for BreastCheck and Assurance Medical anticipates a product launch in January 1999. The company is exploring the possibility of marketing the device to both consumers and practitioners.
Conclusion
Although the product could prove a useful tool in the cadre of breast diagnostic and monitoring products, its worth in terms of clinical value has yet to be proven. This and the present lack of reimbursement produce serious obstacles to optimal market penetration. Few obstetricians and gynecologists will pay out of pocket for a product whose clinical value has yet to be proven while other diagnostic alternatives exist.
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