Walgreen Drug Stores initially plans to begin retail sales of in-home genetic test on Friday that allows the consumer to evaluate his or her risk of diseases such as breast cancer, heart disease and Alzheimer's disease. The largest network of drugstores of the country decided to put sales on hold after a warning FDA, the test is not approved and may put consumers at risk.
The test requires a permit FDA, since it includes a device that allows consumers to collect their own DNA. The Agency is also concerned about the fine line between medical diagnosis and the simple provision of information to consumers.
FDA Press Secretary Erica Jefferson said, "We have no record of this test are presented for approval or clearance, so we'll look at the claims. We want to make sure that the information provided to the consumer, is accurate and that any product is going to to do what he says. "
Jim Cohn, a spokesman for Walgreen said: "In light of the FDA contacting Pathway Genomics of its genetic test kit and anticipated ongoing discussions between the two parties, we decided not to go ahead with the proposed path of the product to our customers until we have further clarity on this issue "said Jim Cohn, Walgreens spokesman.
Path test, called Insight, already in the interactive mode, as well as similar tests. Recently, actress Glenn Close had her genome sequence by a company called Illumina, which was more in-depth study of the structural characteristics of DNA, for example, deletions and restructuring. Her desire to take the test associated with a family history of mental illness, according to the Huffington Post.
The test kit is made by Pathway Genomics, consists of a tube of saliva collection and postage-paid envelope for customers to send their samples Path lab for testing. In the laboratory, the test is not only the human genome sequence, but instead looks at the most common genetic variations of code called single nucleotide polymorphisms, or SNP, which are associated with risk of disease, health status, as well as sensitivity to certain drugs.
According to the company's site, track test report of genetic risks for about 61 diseases and susceptibility to adverse events during the eight drugs. Only adults can get their full test results. Children under 18 will receive only those risks that affect the health of children.
Jeffrey Vance, MD PhD, chairman of genetics at the University of Miami Miller School of Medicine, said in an interview with WebMD, that way the tests are likely accurate, because it was not sequenced the entire genome. This means that the test could probably pinpoint the common variations of genes, but can not give information about the less variation, which also increases the risk.
Must pass a test approved by FDA, Walgreen will sell test from $ 20 and $ 30, with the exception of New York state, where laws are already in a block sale of the test. However, this is not where the cost of consumer applications.
In order to obtain the results (online), the user must select one of the following packages: "Drug Response" Results for $ 79, "Pre-pregnancy planning" for $ 179, and "Health Conditions" for $ 179. Get all the results will be worth $ 249.
Genetic testing to help dieters lose weightGenetic counseling for positive results is also available at $ 40 per 20 minutes of talk time or $ 99 per hour.
If you buy a genetic test for a personal health risk, what will you do with the results? Point test to determine the health risks of certain conditions which are not managed, so you can take steps to lifestyle habits that are under your control. Genes are only part of the equation for good health. For example, if the test tells you that you have a predisposition to diabetes, you have to work to support the weight with a healthy diet and regular exercise, and ask your doctor about fasting blood sugar at an annual medical examination.
The test requires a permit FDA, since it includes a device that allows consumers to collect their own DNA. The Agency is also concerned about the fine line between medical diagnosis and the simple provision of information to consumers.
FDA Press Secretary Erica Jefferson said, "We have no record of this test are presented for approval or clearance, so we'll look at the claims. We want to make sure that the information provided to the consumer, is accurate and that any product is going to to do what he says. "
Jim Cohn, a spokesman for Walgreen said: "In light of the FDA contacting Pathway Genomics of its genetic test kit and anticipated ongoing discussions between the two parties, we decided not to go ahead with the proposed path of the product to our customers until we have further clarity on this issue "said Jim Cohn, Walgreens spokesman.
Path test, called Insight, already in the interactive mode, as well as similar tests. Recently, actress Glenn Close had her genome sequence by a company called Illumina, which was more in-depth study of the structural characteristics of DNA, for example, deletions and restructuring. Her desire to take the test associated with a family history of mental illness, according to the Huffington Post.
The test kit is made by Pathway Genomics, consists of a tube of saliva collection and postage-paid envelope for customers to send their samples Path lab for testing. In the laboratory, the test is not only the human genome sequence, but instead looks at the most common genetic variations of code called single nucleotide polymorphisms, or SNP, which are associated with risk of disease, health status, as well as sensitivity to certain drugs.
According to the company's site, track test report of genetic risks for about 61 diseases and susceptibility to adverse events during the eight drugs. Only adults can get their full test results. Children under 18 will receive only those risks that affect the health of children.
Jeffrey Vance, MD PhD, chairman of genetics at the University of Miami Miller School of Medicine, said in an interview with WebMD, that way the tests are likely accurate, because it was not sequenced the entire genome. This means that the test could probably pinpoint the common variations of genes, but can not give information about the less variation, which also increases the risk.
Must pass a test approved by FDA, Walgreen will sell test from $ 20 and $ 30, with the exception of New York state, where laws are already in a block sale of the test. However, this is not where the cost of consumer applications.
In order to obtain the results (online), the user must select one of the following packages: "Drug Response" Results for $ 79, "Pre-pregnancy planning" for $ 179, and "Health Conditions" for $ 179. Get all the results will be worth $ 249.
Genetic testing to help dieters lose weightGenetic counseling for positive results is also available at $ 40 per 20 minutes of talk time or $ 99 per hour.
If you buy a genetic test for a personal health risk, what will you do with the results? Point test to determine the health risks of certain conditions which are not managed, so you can take steps to lifestyle habits that are under your control. Genes are only part of the equation for good health. For example, if the test tells you that you have a predisposition to diabetes, you have to work to support the weight with a healthy diet and regular exercise, and ask your doctor about fasting blood sugar at an annual medical examination.
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