Clinical trials are to sample 175 women. Here is an article I found from March. According to this article, First Warning System will begin marketing the FWS Smart bra through Apollo Hospitals in India in late 2014. Apollo is a well respected hospital chain.
LLBO will need to get the DTC chill lifted soon and the stock can trade. LLBO is 50% owner of FWS. They need to file the proper paperwork to get this done.
This Smart Bra Can Detect Breast Cancer Much Earlier Than Existing Screening Tests
First Warning Systems’ smart bra that spots changes in breast cell mechanism to detect early signs of breast cancer is set to go to clinical trials in the third quarter of this year.
By nuviun digital health on Thursday 6th of March 2014
In 2012, the latest available global figures, 1.7 million women were diagnosed with breast cancer and 522,000 women died from it. There were 6.3 million women alive who were diagnosed with breast cancer from the previous five years.
While survival rates for breast cancer have recently been increasing, especially in developed countries, early detection still remains the best option to preempt and defeat it.
However, the most widely used breast cancer detection test mammography has high ratios of false positive results (showing cancer when there really isn’t) and false negative results (not showing cancer when there is). It misses one in five cancers and falsely reports cancer in 7% of the cases. Over a period of 9 years, the cumulative false positive rate could be as high as 43.1%. Mammography tests also expose women to radiation which increases the risks of breast cancer.
Now a Nevada-based health technology company First Warning Systems believes that it can resolve many such issues with the existing breast cancer detection methods. By using a bra laden with thermodynamic sensors, it claims to have significantly reduced the rate of false positives and false negatives and detect breast cancer much earlier than the existing screening systems.
When unwanted mutations cause body cells to multiply uncontrollably, they do not just depend on normal blood vessels for blood supply. To support the growth, tumors grow their own abnormal blood vessels. Constant blood flow in these vessels creates a distinct heat signature within the tumor and provides us with the opportunity to detect the presence of cancerous cells.
The Circadian Biometric Recorder sensors embedded in the bra pick up these minute changes of circadian rhythm-based temperature variances of cell cycles on a 2 to 12 hour bases to identify abnormalities in the earliest stages of cell augmentation.
However, what makes First Warning System (FWS) technology different from many other firms trying to develop cancer screening kits using the same approach is its predictive analytics software called Computer Aided Physiological Profile (CAPP).
Developed in partnership with Nanyang Technological University and Lytix, Inc., the software program uses a series of algorithms and neural networks to detect and separate abnormal growth patterns from healthy and normal cellular growth. By carefully observing distinct and dynamic thermal footprint generated during various phases tumor generation, the program classifies tissue into normal, benign, suspicious, cancer in-situ and cancer.
“Feedback from the Circadian Biometric Recorder would be delivered to a physician or patient on a computer or mobile device. It’s designed for use by a physician or outpatient clinic as well as eventually for home use,” said Rob Royea, CEO of First Warning Systems.
The core technology was first tested on over 650 women with promising results. The results were then fed into the analytics software to fine-tune the interpretive system. “The resulting analytics produced were merged into a predictive analytic engine through five years of work at Nanyang Technological University in Singapore,” Royea said. “We are now leveraging what we have learned from our predicate analog devices and applying our patented analytics we developed through Nanyang into our digital solutions.”
The company is planning to conduct the first set of clinical trials on 175 women who underwent mammography or other types of screening tests under the supervision of Dr. Joshua Ellenhorn, a surgical oncologist at Cedars-Sinai Medical Center.
“Our findings will then be compared to the historic 70 percent false positive population of patients that are sent to biopsy as a result of mammography,” Royea said. “The anticipated outcome of the study should result in an increased confidence level for the physician decision processes on which patients are most likely to receive positive biopsy results post mammography or ultrasound.”
If these tests are successful, the technology will initially be launched in India through Apollo Hospitals’ network of 55 multispecialty hospitals and 1800 retail pharmacy outlets in late 2014. The company expects to get an FDA clearance next year and intends to launch the product in the US by the end of 2015.
“Screening for breast cancer in the home will become a reality both here in the U.S. for the newly notified dense breast tissue patients and in the breast cancer epidemic regions of Asia, where massive populations are unable to, or cannot afford to, access hospital screening.” Of Arnoldb 04/25/14
If this non-invasive and non-radiogenic smart bra proves to be accurate, then it would greatly reduce misdiagnoses, help early tumor detection and facilitate timely medical interventions to potentially save hundreds of thousands of lives and reduce billions of dollars in healthcare costs.
Apollo Hospitals was the forerunner of integrated healthcare in Asia, as well as globally. Today, the group's futuristic vision has ensured that it has been in a position of strength at every touch point of the healthcare delivery chain. Its presence encompasses over 10,000 beds across 61 hospitals, more than 1500 pharmacies, over 100 primary care & diagnostic clinics, 115 telemedicine units across 9 countries, health insurance services, global projects consultancy, 15 academic institutions and a Research Foundation with a focus on global clinical trials, epidemiological studies, stem-cell and genetic research.
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