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[IP] home hba1c test approved by FDA

I just received this interesting press release, thought you'd like to 
see it as well.

email @ redacted


        The Food and Drug Administration (FDA) has cleared the first
over-the-counter test that measures glycated hemoglobin in people with
diabetes to help monitor how well they are managing their disease
(glycemic control).  The test, called Metrika A1c Now, is currently 
available by prescription only.  Over-the-counter status means that 
the test can now be purchased without a prescription and used at 
home, with results on the spot, making it readily available to people 
with diabetes.

        Diabetes is a chronic disease in which blood glucose (sugar) 
levels are too high.  Abnormally high levels of glucose can damage 
the small and large blood vessels, leading to blindness, kidney 
disease, amputation of limbs, stroke, and heart disease.

         Glycated hemoglobin is a unique substance created as a result
of interaction between hemoglobin and glucose. The level of glycated 
hemoglobin provides information on the average level of glucose in 
the body over a 90 to 120 day period of time. The glycated hemoglobin 
test should be performed two to four times a year to monitor 
long-term control over blood glucose levels.  Glycated hemoglobin 
tests provide information to complement that obtained from daily 
finger stick blood glucose tests that measure glucose at a single 
point in time. To perform the Metrika A1c Now test, the patient takes 
a blood sample from his finger with a lancet and places it in a 
monitor.  The monitor displays test results in eight minutes.  Unlike 
some other products, there is no need to send the sample back to the 
physician to get results.  The patient gets the results on the spot.

        FDA cleared the test for non-prescription use based on a
        clinical study conducted by the manufacturer, Metrika, Inc., 
of Sunnyvale, Calif. The study compared test results obtained by lay 
users of the device to test results obtained by medical 
professionals.   In the study, 286 patients-271 diabetics and 15 
non-diabetics-used the test without physician supervision. The 
results were comparable to those obtained by medical professionals. 
The Metrika A1c Now test has been certified by the National 
Glycohemoglobin Standardization Program, an independent certification 
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