FIRST WARNING SYSTEMTM
The First Warning System™
is a non-invasive, non-compressive and non-radiogenic device developed
to assist in the early discovery of breast tissue abnormalities as an
adjuvant to other diagnostic and screening methods. Through a
proprietary (patents issued and patent applications filed…see the
Intellectual Property section of this website), algorithm
based interpretive software program called CAAP (computer aided physiological
profile) it provides a physical assessment of over 4,750 data points
(temperature readings) from the underlying tissue in the breast.
It is believed that variations in breast temperatures and their related
circadian rhythm (24-hour cycle in the biochemical, physiological, or
behavioral processes of living entities) chaos may be caused by tumor
angiogenesis (a physiological process involving the growth of new blood
vessels from pre-existing vessels often associated with tumor growth).
Data capture and CAAP are not
related to thermography. Instead, temperature fluctuations in
the breast tissue are recorded over a period of time and analyzed for
pattern recognition with powerful algorithms (trained by neural network
analytic systems) creating a dynamic (as opposed to a static image as
would be the case with a mammogram or MRI) impression of the changes
in breast tissue temperature over time. The use of a neural
net analytic system results in better sensitivity and specificity.
Sensitivity measures the proportion of actual positive test results
which are correctly identified as such. Specificity measures the
proportion of negative test results which are correctly identified.
Sensitivity and specificity are statistical measures of the performance
of a binary classification test. A binary classification test
is the task of classifying the members of a given set of objects into
two groups on the basis of whether they have some
property or not. A typical binary classification task is a medical test
to determine if a patient has a certain disease or not. The CAAP analytic
system is thoroughly and completely automated and without human visual
interpretation, as no picture is produced. In contrast, thermography
uses an infrared camera to create an image which is then interpreted
by a trained individual. Because the image obtained from thermography
is subjectively interpreted, output is low in sensitivity and specificity.
The First Warning SystemTM
is a contact active thermal analysis system recording vibrant changes
in true temperatures with contact thermistors designed specifically
for biological use. The temperature recordings are then analyzed
by multiple neural networks. The biological thermistors are interchangeable
and accurate to within .001 of one degree centigrade.
The First Warning SystemTM
is capable not only of identifying breast tissue abnormalities at their
earliest stages, but can also identify the general location of such
abnormalities in three dimensions to each of the four quadrants of each
breast. It is, therefore, not intended as an additional step in
the breast cancer screening process, but as an accurate identifier of
early breast abnormalities which generate heat via the presence of new
blood vessels that nourish the area in question. As such, it is
a more precise feeder to other diagnostic modalities that are invasive
as well as more costly. This approach to discovery aids in reducing
the number of unnecessary procedures such as MRI and mammograms, as
well as reducing the number of misdiagnosed issues related to the more
accepted means of screening/detection.
The goal of the First Warning
System™ is to enhance clinical breast examination aiding in the
reduction of superfluous mammograms, needless biopsies, and other screening/diagnostic
procedures, as well as to develop a physiological profile of the changing
breast temperature picture over time, thereby identifying breast tissue
abnormalities at their earliest stage.
At the patient’s physician’s office, sixteen tiny color-coded sensors
are attached (taped) to the patient’s breasts in a predetermined (patent
issued) areas directly related to the National Tumor Registry’s record
of reported breast cancer occurrences. These sensors measure temperatures
at programmed times over a predetermined testing period. The data
is stored in a small proprietary recording device (patent issued) that
is worn by the patient. During the testing period the patient
can go substantially about her daily activity. At the end of the
test period the patient returns the storage device to their physician’s
office. The sensor’s are removed and the data downloaded and
sent via the Internet under HIPAA guidelines to First Warning’s interpretive
center, where it is analyzed by the proprietary (patent applied) neural
The patient’s physiologic
data is compared against data from a database of pathologically proven
cases of breast tissue abnormalities including cancer showing physiological
abnormalities which may require follow up with mammography, MRI, biopsy
or other diagnostic modalities. The test will show one of four
conditions of the breast tissue: Normal, Benign, Suspected for breast
tissue abnormalities, or Probable for breast tissue abnormalities.
A report is immediately returned
to the physician. The physician and the patient can then discuss
the physician’s clinical recommendations.
Over 500 women have been tested
with the First Warning System™ in three venues: Ohio State
University, Division of Surgical Oncology Center, Arthur G. James Hospital
and Richard J. Solove Research Institute; Green Memorial Hospital, Dayton,
Ohio and the C.L.E.M.P.L.A.M Breast Clinic, La Plata University, La
The development of First Warning
System™ and the testing of over 500 patients has produced a Sensitivity
in the 94% range and a Specificity in the 90% range. These results
compare to an estimated 70% specificity/sensitivity for mammography.
The Mastascope is a ultraslim, hand held endoscope designed to enter the
breast nipple via one of its milk ducts, thus permitting the physician
to visualize the interior aspects of the breast. Because many
cancers actually begin within an individual milk duct, these intaductal
tumors are visualized easily and can be biopsied. This product
has been used in leading breast centers in the United Kingdom and other
countries with great success. Lifeline has obtained a CE mark
for marketing and distribution in Europe.
has developed and tested an ultraslim endoscope to directly visualize
the ovarian surface in the search for cancer. This is of great
advantage to physicians, because neither MRI, Xray or Ultrasonography
can provide accurate assessment of subtle surface changes. Initial
reports of clinical usage have been encouraging.
issued 8/24/99, Utility: Method and Apparatus for Detection of Cancerous
and Precancerous Conditions in a Breast.
issued 6/6/06, Utility: Apparatus and Method for Identifying and Monitoring
Women at Risk of Developing Ovarian Surface Epithelium Derived Carcinomas.
PATENTS APPLICATIONS PENDING:
filed 8/27/09, Method/Process: A Device for Analyzing Thermal Data Based
on Breast Surface Temperature for the Detection for Use in Determining
filed 8/27/09, Utility: System for Analyzing Thermal Data Based on Breast
Surface Temperature to Determine Suspect Conditions.
filed 8/27/09, Utility: Methods for Collecting and Analyzing Thermal
Data Based on Breast Surface Temperature to Determine Suspect Conditions.
No. 78340795; Registration No. 2966626, Mark: Lifeline Biotechnologies,
No. 78340830; Registration No. 2980880, Mark: First Warning
No. 78342034; Registration No. 2983003, Mark: Ovascope
No. 78364593; Registration No. 2962430, Mark: Licam
No. 78467938; Registration No. 3065257, Mark: Mastascope
Number K881813: Issued by the FDA November 4, 1988 to Chronodynamics
Ltd. Description: A Medical Device, as an Intelligent Portable
Data Recorder for Skin Temperature Measurement. Up to 16 Sensors
at Various Locations. Lifeline Biotechnologies acquired the 510
(k) from Chronodynamics in the early 1990s.
Number K962246: Issued by the FDA November 14, 1996 to Saber
Endoscopy, titled Rigid FiberOptic Gynecologic Laparoscopes. Five
Star Medical acquired this 510 (k) from Saber Endoscopy in December
1997. Lifeline Biotechnologies, Inc. acquired this Rigid FiberOptic
Gynecologic Laparoscopes 510 (k) from Five Star Medical December 30,