Metrika, Inc., announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to make its A1cNow diabetes monitor available to patients over-the-counter, without a prescription.

A1cNow is the first and only test diabetes patients can now use at home to obtain immediate glycated hemoglobin (HbA1c or A1C) results - the gold-standard indicator of diabetes control and risk of serious long-term complications.

A recent survey by the American Association of Diabetes Educators found that 75% of people with type 2 diabetes do not know their A1C number. Studies have shown that A1C testing, previously performed only in a hospital laboratory or physician's office, is widely underutilized. A 1% reduction in A1C can reduce the risk of complications such as blindness, kidney failure, amputations, heart disease and stroke by as much as 35%, and reduce the risk of death by 25%. Yet less than half of the 17 million Americans with diabetes are estimated to have achieved the American Diabetes Association's (ADA) recommended A1C level of 7% or less.

The first in Metrika's Now line of diabetes monitoring devices, the disposable, pager-sized A1cNow Monitor provides quantitative A1C results in just 8 minutes from a small drop of blood. A1cNow is available through mail order and soon through pharmacies nationwide for a retail price of $22-$25.

"The A1C test is crucial for intensive management of diabetes," said Steven Edelman, MD, founder, and director of Taking Control of Your Diabetes, a nonprofit organization promoting education, motivation, and self-advocacy for people with diabetes, and professor of medicine at the University of California San Diego School of Medicine. "A1cNow provides people living with diabetes an important new tool to proactively manage their diabetes along with their caregivers. In addition, A1cNow allows for immediate and convenient access to this important measure of their diabetes control at home, while avoiding a visit to a laboratory, a painful venipuncture in the arm, and delays in obtaining the result."