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Archive - 05 - 2013

FDA Allows Marketing of First A1c Test Labeled for Diagnosing Diabetes

Posted by dlife on Thu, May 30, 13, 10:17 AM 0 Comment

May 23, 2013 (FDA) — Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use. The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient's blood glucose (sugar) control, but not for diagnosing diabetes. A1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient's average glucose level over a three-month period. Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the United States have diabetes, including seven million people who remain undiagnosed. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves. The diagnostic criteria for diabetes have changed over time. Based on the research and recommendations of international diabetes experts, many health care providers have already been using some A1c tests to diagnose diabetes, in addition to the established diagnostic procedures of a fasting blood glucose test and an oral glucose tolerance test to diagnose diabetes. However, before today, A1c tests were not specifically designed or granted permission by FDA to be marketed for diabetes diagnosis, making it difficult to know which A1c tests were accurate enough for this purpose. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both accurately diagnose diabetes and monitor blood glucose control. "Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices at FDA's Center for Devices and Radiological Health. "As the Tina-quant HbA1cDx assay was designed for diabetes diagnosis and has been reviewed by the FDA, physicians can have confidence that this test is reasonably safe and effective when used for its intended purposes of monitoring and diagnosing diabetes." In support of marketing clearance, investigators analyzed 141 blood samples and found less than six percent difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for hemoglobin analysis. The Tina-quant HbA1cDX assay is available by prescription for use in clinical laboratories. Over-the-counter HbA1c tests should not be used by patients to diagnose diabetes, and only a qualified health care professional should make a diagnosis of diabetes. Individuals who receive a diabetes diagnosis should discuss with their physician what they need to do to manage their diabetes. Hemoglobin A1c tests, including the Tina-quant HbA1cDx assay, should not be used to diagnose diabetes during pregnancy and should not be used to monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies, or severe chronic, hepatic and renal disease. This test should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F. The Tina-quant HbA1cDx assay is manufactured by Roche, of Basel, Switzerland. Roche's North American headquarters are located in Indianapolis, Ind.

Diabetes' Genetic Underpinnings Can Vary Based on Ethnic Background, Studies Say

Posted by dlife on Thu, May 30, 13, 10:13 AM 0 Comment

May 23, 2013 (Stanford School of Medicine) — Ethnic background plays a surprisingly large role in how diabetes develops on a cellular level, according to two new studies led by researchers at the Stanford University School of Medicine. The researchers reanalyzed disease data to demonstrate that the physiological pathways to diabetes vary between Africa and East Asia and that those differences are reflected in part by genetic differences. The studies published online simultaneously May 23 in the journals PLoS Genetics and Diabetes Care. "We have new insights into the differences in diabetes across the world, just by this new perspective applied to older studies," said Atul Butte, MD, PhD, senior author of the studies and chief of the Division of Systems Medicine and associate professor of pediatrics and of genetics. "There's more still to learn about diabetes than we knew." The early stages of type-2 diabetes, or adult-onset diabetes, can develop when the pancreas has problems creating sufficient insulin, a hormone critical for regulating blood sugar, or when the body's cells have trouble responding to insulin, a condition called "insulin resistance." Both problems will lead to the same result: too much sugar in a person's blood stream, which is the main criterion for diagnosing diabetes. Diabetics develop both low insulin secretion and insulin resistance as the disease progresses. In the study published in PLoS Genetics, the researchers started by studying genome information of more than 1,000 people in 51 populations from around the world. These individuals were from indigenous populations, representing the earliest groups of humans at various locations. Lead author and former graduate student in Butte's lab, Erik Corona, PhD, studied more than 100 diseases searching for genetic differences in risk across these native populations, and found a clear geographic pattern in the genetics behind type-2 diabetes. The genetic risk is highest for Africans and drops along the trajectory the first humans took when migrating out of Africa toward East Asia (primarily Japan, China and Korea), where diabetes-linked genes appear to be more protective. Based solely on what is currently known about type-2 diabetes genetics, native Africans would appear to be at higher risk for diabetes, while East Asians would appear to be protected. But East Asians are not necessarily at lower risk of diabetes than Africans. Butte pointed out that "East Asians definitely get diabetes. What we would argue is that diabetes may be a different disease" in East Asian populations. An interactive tool that displays the results can be found at http://geneworld.stanford.edu/hgdp.html. The genetics study's findings led Butte's team to wonder if there was clinical evidence of these differences in African and East Asian populations. For the second paper, lead author and staff engineering research associate Keiichi Kodama, MD, PhD, pulled data from more than 70 papers looking at simultaneously measured insulin secretion and insulin resistance in individuals across three different ethnic groups: Africans, Caucasians and East Asians. They found that at baseline, Africans had higher insulin resistance but were able to compensate with higher insulin secretion. East Asians were more likely to have less insulin-secretion ability, but this was compensated by having normal insulin resistance. Caucasians fell between these two groups, though they were more likely to develop problems with insulin secretion. The researchers showed that because individuals from each ethnic group start at a different baseline position, they each reach diabetes in a different way: Africans through increased insulin resistance, and East Asians through lower insulin-secretion ability. "Africans are already pretty insulin resistant," Butte said. "They need their beta cells to work really hard. If their cells fail, that's how they head toward diabetes." East Asians, in contrast, "don't have a lot of spare capacity to secrete more insulin." The findings were published in Diabetes Care. Butte notes that a shift in how clinicians think about diabetes could lead to more targeted therapies, much as how thinking about cancer has evolved over the past 10 years, leading to new treatments. "Other fields of medicine have undergone a radical rethinking in disease taxonomy, but this has not happened yet for diabetes, one of the world's public health menaces," he said. "If these are separate diseases at a molecular level, we need to try to understand that." Other Stanford co-authors include past bioinformatics scientist Rong Chen, PhD; Carlos Bustamante, PhD, professor of genetics and co-director of the new Stanford Center for Computational, Evolutionary and Human Genomics; former graduate students Alexander Morgan, PhD, and Aditya Ramesh, MS; and postdoctoral scholars Chirag Patel, PhD, and Martin Sikora, PhD. Scientists at Lund University in Malmo, Sweden, and Kitasato University in Tokyo were also involved in this work. These studies were supported by grants from the Howard Hughes Medical Institute, the National Library of Medicine (R01LM009719) and the Lucile Packard Foundation for Children's Health. Information about Stanford's Department of Pediatrics, which also supported the research, is available at http://pediatrics.stanford.edu/.

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