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RENO, Nev. — It's been more than 15 years in the making, but Reno-based First Warning Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart Bra.
The device makes it easier and more economical to detect breast cancer in younger women, who usually have denser breast tissue, making traditional mammogram results hard to read.
Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected earlier.
"There are a number of studies out over the past 10 years that say the earlier we can identify this disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage 2."
Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast cancer researcher, agrees that there is a need for better early detection of breast cancer, especially in young women and pre-menopausal women.
"There is a great need to develop technologies that can make progress in the war against breast cancer," he said.
The bra also can be used to track how well treatment is helping women already diagnosed with breast cancer.
SMART BRA DESIGN
The product is designed to look like a sports bra, but it is embedded with 16 small temperature sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.
Bernardis said his company's No. 1 goal is to implement screening starting at age 18.
The bra is different than the usual mammograms and biopsies because it doesn't compress the tissue, it doesn't use radiology and it's noninvasive.
"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the cell cycle over a 24-hour period."
The Smart Bra relies on temperature readings during the test period. It detects the higher temperature that signals blood vessel growth that preceded abnormal breast tissue growth. Disease cells start destroying healthy tissue around it.
"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."
The sensors within the bra recorded the difference in temperature between healthy cells and diseased tissue.
The device would be prescribed by the doctor to a patient. She then would be outfitted at the office with the garment and a removable flash drive that records the data. The patient can then go about her daily routine and remove the garment after the prescribed time period.
The patient can then mail or return the recording device back to the physician's office, where the data would be uploaded to First Warning Systems' data center in Reno.
She can keep the garment for the next annual exam.
The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics software program. It analyzes and processes the information through First Warning Systems' proprietary algorithm to identify the condition of breast.
This process should take less than 30 seconds to generate a report for the doctor.
The report has four different readings: normal, benign, suspected for breast tissue abnormalities or probable for breast tissue abnormalities.
The results then are sent to the doctor to handle the diagnosis and treatment, if needed.
The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy rate, according to First Warning. The trials used a screen mammogram as a comparison.
"We are not looking to take out the mammogram," Bernardis said. "We are just looking to provide a tool that does a better job in a population that is currently underserved."
The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the United States before release in 2014.
The company is close to commercialization of its product after 15 years of research and development.
First Warning is projecting that the clinical Smart Bra would cost about $200, while each report would be $10 to $20 per exam. As more people use the device, the prices would decrease.
The company also is working on a direct-to-consumer version of the Smart Bra that could replace the self-breast exam, but it is not as advanced as the professional version. It would be a subscription-based fee.
"Our goal has been — really in a nebulous sense — to try to change the approach to health care in Western countries from that of a reactive nature to a proactive nature," Bernardis said.
INVESTING IN RENO
First Warning Systems is vested in Reno and committed to growing its medical device software firm in Northern Nevada.
"It would be much, much easier and much less expensive to offshore, if you will, but that is the last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs here, help put a new face on Reno in the tech and medical sector."
Even though the company receives most of its funding from Silicon Valley and gets requests to move closer to its investors, core management is headquartered in a building near the Reno-Tahoe International Airport.
The company finds the business startup climate to be more friendly and supportive, Bernardis said. As it moves from research-and-development stage to commercialization, the company will be adding more jobs to the area. It currently employs seven people.
Currently, most of its consultants and advisers are located around the world, but First Warning is using local firms for building and engineering of its device. It also is building up its in-house software development department, which would raise the level of jobs offered in the area.
Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300 participants. The firm is putting together a medical and management team.
"One of our greatest hopes is that we can do a multisite study throughout the United States, mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."
Information from: Reno Gazette-Journal, http://www.rgj.com