LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Oct. 14, 1999-- While diabetes rages as the nation's seventh leading killer and increasingly targets children, studies show that many diabetes patients are ignoring an important blood sugar monitoring test -- the Hemoglobin A1c (HbA1c) test -- that doctors deem critical to long-term management of the disease. To counter the lack of compliance among many patients in taking this laboratory test, BioSafe Diagnostic Products today introduced a new HbA1c test kit that enables patients to collect their own blood sample for lab analysis and physician interpretation with unprecedented convenience and accuracy. The new BioSafe HbA1c test uses a proprietary method of re-hydrating dried blood samples that produces readings as accurate as tests conducted with liquid samples. The new test kit is available by prescription only and can be purchased soon at pharmacies nationwide.
A landmark study (the 1993 Diabetes Control and Complications Trial) showed that maintaining proper blood sugar control can reduce the risks of diabetes-related complications -- including blindness, kidney failure and nerve disease -- by a range of 35 percent to more than 70 percent. Hemoglobin A1c testing is one of the best ways to determine overall blood sugar control. Despite its importance, however, numerous studies show that diabetes patients are often ignoring the HbA1c test. The American Diabetes Association recommends that anyone with diabetes have an HbA1c test at least twice a year. Every three months is better, especially for those using insulin.
``Recent surveys suggest that a majority of people with diabetes are still not having the test done even once a year,'' said Thomas Pitts, M.D., and immediate past president of the American Diabetes Association's Great Lakes Region. ``And so we have more work to do.''
``Until now, people with diabetes have typically had to follow up a doctor's appointment with a second trip to a lab or clinic to have their blood drawn for the HbA1c test,'' said Hank Warner, president of BioSafe Medical Technologies, Inc., the parent company of BioSafe Diagnostic Products. ``That's where the system would often break down -- people just wouldn't go. BioSafe's new HbA1c test uses state-of-the-art technology which makes the test more accessible to patients -- thereby increasing opportunities for compliance. And, because it can be done in advance of a patient's next doctor's appointment, that visit can be more productive. In essence, the BioSafe HbA1c test can be the best first step to a patient's next doctor visit.'' Mr. Warner noted that physicians may also administer the test in their office during the patient's visit.
``Studies have confirmed that the HbA1c test is the best test for a health care provider to tell if a patient's blood sugar is under control,'' said Stuart Rollin Weiss, M.D., endocrinologist with the San Diego Endocrine and Medical Clinic. ``However, too many people with diabetes don't comply with this critical test. BioSafe's HbA1c test is accurate and convenient and will hopefully enable more people to get tested.'' Education Effort
BioSafe today also announced the launch of a public education effort, consisting of media outreach and distribution of videos, brochures and other materials to the diabetes community, to help increase awareness of the HbA1c test's important role in managing diabetes. Miss America 1999, Nicole Johnson, an insulin-dependent diabetic, will serve as the spokesperson for the campaign launch.
``Conscientious monitoring of my condition, including working with my doctor to use the Hemoglobin A1c test, lets me enjoy a full life,'' said Ms. Johnson. ``With BioSafe's new, self-collected test, there's no reason millions of Americans can't take advantage of the same information that enables my doctors and me to manage my diabetes effectively.'' Ms. Johnson was diagnosed with the disease in 1993.
To help increase compliance with the HbA1c test, particularly among children, the company has worked with Tiger Electronics, Ltd./Hasbro, Inc. to create a ``doctor'' finger puppet based on Furby(TM), one of the world's best selling toys. Children are typically affected with Type 1 (insulin-dependent) diabetes, the disease's more severe form. Through an exclusive agreement with Tiger Electronics, Ltd./Hasbro, Inc., all diabetes patients will receive a Furby(TM) finger puppet when they purchase a BioSafe HbA1c test kit. In addition, those who comply with the recommended number of four tests a year will receive a complimentary electronic Furby(TM) toy.
Through the BioSafe Foundation, the company will also make its finger puppet featuring Furby(TM) available for outside sale in order to raise money for diabetes research, education and treatment. The company is already in discussions with diabetes organizations and medical facilities around the country to use the character for fund-raising. The BioSafe Foundation intends to raise $3 million in its first year of operation.
How the BioSafe HbA1c Test Works
The BioSafe HbA1c test is easy to use. Patients can use the kit's finger lancet to collect their blood while routinely checking their blood sugar levels. After putting three drops of blood on a collection card, the patient drops the card into a specially sealed packet and mails it in the postage-paid envelope to BioSafe's laboratory for analysis. Results are promptly forwarded to the patient's physician, who interprets the results and adjusts treatment protocols accordingly. The test kit's price is $49.95 and is covered by most insurance plans under C.P.T. Code #83036. For more information, health care professionals and consumers can consult the company's Web site: www.ebiosafe.com.
The BioSafe HbA1c test marks the first time the company's proprietary micro-sample technology has been applied to diabetes management. Other tests currently available are a Total Cholesterol Panel (lipid profile) for management of coronary heart disease, Bone Alkaline Phosphatase (BAP) for osteoporosis management, and Prostate Specific Antigen (PSA) for prostate cancer screening. Within the next 12 months three additional test are scheduled for release: a Liver Enzyme Panel (GGT, AST, ALT), BUN and Creatinine (kidney function), and TSH (thyroid stimulating hormone).
BioSafe Diagnostic Products, Inc. is a unit of Lincolnshire, Illinois-based BioSafe Medical Technologies, Inc., which develops and markets diagnostic products and services using proprietary micro-sampling technology, to health care professionals and consumers. The company has developed state-of-the-art Dried Blood Spot micro-sample testing procedures that enable patients and physicians to work together to monitor various medical conditions with unprecedented convenience, accuracy and cost-effectiveness. The company is privately-owned and was founded in 1995.
Healy Communications Tracy Morris or Steve McKay, 312/440-3900 or Paige Wasson, 202/467-8235
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