About the Company.
FlexSite Diagnostics, Inc.
FlexSite specializes in facilitating lab testing from home. We manufacture sample collection kits that are tailored to
allow mailing of dry samples of blood or urine to our clinical laboratory.
FlexSite also operates a highly specialized clinical laboratory to test the dry mailed-in samples. FlexSite's clinical
laboratory is certified and licensed under Federal CLIA standards, and is licensed in the states of New York,
Pennsylvania, Maryland, Rhode Island, and Florida. Our FlexSite team is able to service each of the 50 United
States and the District of Columbia.
Our company's first product, A1c At Home(R) , was cleared by the Food and Drug Administration in 1997. This
product is an essential disease management tool for improving outcomes in individuals with diabetes. Our HbA1c
Kit is the FIRST of its kind to be approved by the FDA for at-home consumers, and is also utilized by disease
management programs, pharmaceutical marketers, and managed care companies.
FDI's second product, KidneyScreen At Home Test(R), was cleared by the FDA in August 2001, and accurately
provides the earliest clinical evidence of kidney dysfunction at its earliest stage making it possible to reverse
further kidney damage through preventative measures!
Our focus continues to be on diabetes while our passion and commitment are to expand into cardiovascular
disease and women's health. Future products include a Osteoporosis management test and a test for the early
detection of liver disease.
Our company's principal, Robert Ray, PhD., (President and CEO) has over 30 years of diagnostic and medical
device management experience with leading medical and diagnostic companies such as Beckman Instruments
(now Beckman Coulter), Dade (now Behring Dade), and Coulter, (Beckman Coulter).
Helping you manage your health is our business, and we strive to provide you with the accurate tools to make it
convenient and affordable.
© 1995 to 2004 FlexSite Diagnostics, Inc. All rights reserved.
RECENT NEWS:
January 16, 2002 FlexSite Diagnostics Announces Licensing Arrangement with
Liberty Medical Supply, Inc.
Medicare beneficiaries will soon be able to do the most important test for diabetes management in the
convenience of their homes.
PALM CITY, FLORIDA (January 16, 2002) - FlexSite Diagnostics, Inc. Announced today that it has agreed to license
its clinical laboratory technology to Liberty Medical Supply, Inc., a subsidiary of PolyMedica Corporation (NASDAQ:
PLMD). Under this agreement, FlexSite will assist Liberty in the creation of a laboratory to process
Glycohemoglobin (HbA1c) tests. In addition, FlexSite will sell certain products and services to Liberty Medical under
a separate agreement.
HbA1c testing is considered an important test for long-term diabetes management. While glucose monitoring is
vital for day-to-day diabetes management, long-term blood glucose control requires the measurement of average
blood glucose levels. The most accurate measurement of the average glucose level, according to the landmark
Diabetes Control and Complications Trial (DCCT), is the HbA1c test. FlexSite Diagnostics has developed an easy
to use A1c sample collection kit for mail-in laboratory testing. This convenient A1c test kit will be marketed and
distributed under the Liberty Medical brand name.
June 19, 2001 Breakthrough At-Home Kidney Screening Tool
Now Available
Finally, people with diabetes have an easy and convenient way to detect kidney dysfunction in time to avoid
developing kidney disease.
PALM CITY, FLORIDA (June 19, 2001) - FlexSite Diagnostics, Inc. announced today that KidneyScreen At Home™
is now available for purchase. This convenient kit enables diabetes patients to collect a urine sample at home and
mail it to FlexSite's laboratory in a dried state for testing. The test detects small (micro) amounts of albumin (a
protein) in the urine (microalbuminuria), which is the earliest clinical evidence of kidney dysfunction.
According to the American Diabetes Association (ADA), 20%-30% of patients with diabetes develop diabetic kidney
disease (nephropathy). While kidney disease is one of the most devastating complications of diabetes, it's also
highly detectable and treatable in its earliest stages.
The ADA and the American Kidney Foundation (AKF) recommend that everyone with diabetes be tested for
microalbuminuria every year. However, studies have shown that this test is widely underused. This could be for a
number of reasons including a lack of knowledge about the importance of the microalbumin test, along with the
fact that traditional methods of testing are often cumbersome on an outpatient basis-e.g., collecting a 24-hour
urine sample.
With KidneyScreen At Home™, the urine sample is mailed in a dried state to FlexSite Diagnostics' CLIA licensed
laboratory using the proprietary UriSite™ urine collection device. This product is designed for the patient and
physician to use together to monitor the patient's health and help achieve improved diabetes management.
The U.S. Food and Drug Administration (FDA) cleared the KidneyScreen At Home™ test kit for Microalbumin /
Creatinine Testing to be marketed over-the-counter in August 2000. KidneyScreen At Home™is the second product
in FlexSite Diagnostics' line of at-home mail-in laboratory tests for diabetes management.
The first product, A1c At Home™, offers patients a convenient and affordable way to do Glycohemoglobin (HbA1c)
testing. The HbA1c test measures average blood glucose levels over a period of about three months, and is
considered the most important test for long-term management of diabetes. FlexSite's next product will be a
Cholesterol Profile Kit that uses a patented SerSite™ device to collect a dried blood sample for measuring total
cholesterol, HDL cholesterol and triglycerides, along with providing a computed LDL cholesterol.
For more information about KidneyScreen At Home™, A1c At Home™ or upcoming products, call FlexSite
Diagnostics toll free, 1-877-212-8378 or visit their web site at www.flexsite.com.
FlexSite specializes in facilitating lab testing from home. We manufacture sample collection kits that are tailored to
allow mailing of dry samples of blood or urine to our clinical laboratory.
FlexSite also operates a highly specialized clinical laboratory to test the dry mailed-in samples. FlexSite's clinical
laboratory is certified and licensed under Federal CLIA standards, and is licensed in the states of New York,
Pennsylvania, Maryland, Rhode Island, and Florida. Our FlexSite team is able to service each of the 50 United
States and the District of Columbia.
Our company's first product, A1c At Home(R) , was cleared by the Food and Drug Administration in 1997. This
product is an essential disease management tool for improving outcomes in individuals with diabetes. Our HbA1c
Kit is the FIRST of its kind to be approved by the FDA for at-home consumers, and is also utilized by disease
management programs, pharmaceutical marketers, and managed care companies.
FDI's second product, KidneyScreen At Home Test(R), was cleared by the FDA in August 2001, and accurately
provides the earliest clinical evidence of kidney dysfunction at its earliest stage making it possible to reverse
further kidney damage through preventative measures!
Our focus continues to be on diabetes while our passion and commitment are to expand into cardiovascular
disease and women's health. Future products include a Osteoporosis management test and a test for the early
detection of liver disease.
Our company's principal, Robert Ray, PhD., (President and CEO) has over 30 years of diagnostic and medical
device management experience with leading medical and diagnostic companies such as Beckman Instruments
(now Beckman Coulter), Dade (now Behring Dade), and Coulter, (Beckman Coulter).
Helping you manage your health is our business, and we strive to provide you with the accurate tools to make it
convenient and affordable.
© 1995 to 2004 FlexSite Diagnostics, Inc. All rights reserved.
RECENT NEWS:
January 16, 2002 FlexSite Diagnostics Announces Licensing Arrangement with
Liberty Medical Supply, Inc.
Medicare beneficiaries will soon be able to do the most important test for diabetes management in the
convenience of their homes.
PALM CITY, FLORIDA (January 16, 2002) - FlexSite Diagnostics, Inc. Announced today that it has agreed to license
its clinical laboratory technology to Liberty Medical Supply, Inc., a subsidiary of PolyMedica Corporation (NASDAQ:
PLMD). Under this agreement, FlexSite will assist Liberty in the creation of a laboratory to process
Glycohemoglobin (HbA1c) tests. In addition, FlexSite will sell certain products and services to Liberty Medical under
a separate agreement.
HbA1c testing is considered an important test for long-term diabetes management. While glucose monitoring is
vital for day-to-day diabetes management, long-term blood glucose control requires the measurement of average
blood glucose levels. The most accurate measurement of the average glucose level, according to the landmark
Diabetes Control and Complications Trial (DCCT), is the HbA1c test. FlexSite Diagnostics has developed an easy
to use A1c sample collection kit for mail-in laboratory testing. This convenient A1c test kit will be marketed and
distributed under the Liberty Medical brand name.
June 19, 2001 Breakthrough At-Home Kidney Screening Tool
Now Available
Finally, people with diabetes have an easy and convenient way to detect kidney dysfunction in time to avoid
developing kidney disease.
PALM CITY, FLORIDA (June 19, 2001) - FlexSite Diagnostics, Inc. announced today that KidneyScreen At Home™
is now available for purchase. This convenient kit enables diabetes patients to collect a urine sample at home and
mail it to FlexSite's laboratory in a dried state for testing. The test detects small (micro) amounts of albumin (a
protein) in the urine (microalbuminuria), which is the earliest clinical evidence of kidney dysfunction.
According to the American Diabetes Association (ADA), 20%-30% of patients with diabetes develop diabetic kidney
disease (nephropathy). While kidney disease is one of the most devastating complications of diabetes, it's also
highly detectable and treatable in its earliest stages.
The ADA and the American Kidney Foundation (AKF) recommend that everyone with diabetes be tested for
microalbuminuria every year. However, studies have shown that this test is widely underused. This could be for a
number of reasons including a lack of knowledge about the importance of the microalbumin test, along with the
fact that traditional methods of testing are often cumbersome on an outpatient basis-e.g., collecting a 24-hour
urine sample.
With KidneyScreen At Home™, the urine sample is mailed in a dried state to FlexSite Diagnostics' CLIA licensed
laboratory using the proprietary UriSite™ urine collection device. This product is designed for the patient and
physician to use together to monitor the patient's health and help achieve improved diabetes management.
The U.S. Food and Drug Administration (FDA) cleared the KidneyScreen At Home™ test kit for Microalbumin /
Creatinine Testing to be marketed over-the-counter in August 2000. KidneyScreen At Home™is the second product
in FlexSite Diagnostics' line of at-home mail-in laboratory tests for diabetes management.
The first product, A1c At Home™, offers patients a convenient and affordable way to do Glycohemoglobin (HbA1c)
testing. The HbA1c test measures average blood glucose levels over a period of about three months, and is
considered the most important test for long-term management of diabetes. FlexSite's next product will be a
Cholesterol Profile Kit that uses a patented SerSite™ device to collect a dried blood sample for measuring total
cholesterol, HDL cholesterol and triglycerides, along with providing a computed LDL cholesterol.
For more information about KidneyScreen At Home™, A1c At Home™ or upcoming products, call FlexSite
Diagnostics toll free, 1-877-212-8378 or visit their web site at www.flexsite.com.
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| Home I About A1c I About Kidney Screen I Buy Now I Kids and Diabetes I Bulk Sales Info for Professionals I Research Products I Medicare Tests I About FlexSite I Contact |
| FlexSite's A1c kit At-Home test traces its beginnings back to 1987 as the Self Assure Kit for glycohemoglobin. This was the first ever over-the-counter A1c test cleared for marketing by the FDA. FlexSite built on the pioneering product, simplified the production and changed to a more automated testing technology in 1997 in the A1c At-Home kit. |
