Skip to main content

Why is the FDA cracking down on home genetic test$? ' Ashkenazi Jews Genetic Test Panel.' nuff said

Why is the FDA cracking down on home genetic tests? | Yahoo Health

In a move likely to heighten a longstanding controversy about DNA tests for health risks, the U.S. Food and Drug Administration (FDA) has ordered home genetic test maker 23andMe to “immediately discontinue” marketing its saliva collection kit and Personal Genome Service, charging that the company has made claims not backed with solid science.
The FDA warning letter contends that the Google-backed company has failed to show that its $99 test—which claims to check one’s risk for hundreds of diseases and conditions—is safe or effective. The regulators also point out that there could be potential for serious harm if the 23ndme test didn’t work as advertised.
“For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions,” the letter states, “while a false negative could result in a failure to recognize an actual risk that may exist.”
In this scenario, if a woman was mistakenly told that she was a carrier of a BRCA1 or BRCA2 genetic mutation that put her at very high risk for breast and ovarian cancer, she might opt for an unnecessary preventive double mastectomy or undergo surgical removal of her ovaries, ending her fertility.
Also alarming is the possibility that women who are genuinely at high risk for these cancers (like Angelina Jolie) might be left dangerously in the dark if the DNA test incorrectly said they were not carriers of BRCA mutations.
It's easy to see the appeal of a simple home test that will uncover lots of interesting facts about your body and predict your risk of disease. But right now, it seems those tests are largely overhyped and can actually threaten your health by giving you false information.
Medically supervised genetic testing (performed in a doctor's office) is still a viable and accurate way to assess health risks for certain patients, but the at-home "direct-to-consumer" tests have been under fire since they hit the market.

A Lack of "Scientific Validity" 

The FDA’s action comes after years of controversy about the accuracy of at-home genetic tests—also known as direct-to-consumer (DTC) tests—for health risks, which are offered online by such companies as DNA DTCDNATraits, and GenePlanet.
One of these firms, DNATraits, had issues with the FDA in 2010, in connection with its Ashkenazi Jews Genetic Test Panel. At the time, 14 makers of genetic tests also received FDA letters, as part of a crackdown that also included an earlier warning to 23andme.
The Federal Trade Commission has long warned consumers that “some [DTC tests] lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation.”

Genetic Testing Facilities and Cost
Last modified on September 17, 2012 at 6:55 pmLeer esta página en español

Testing for BRCA1 and BRCA2 is usually done on a blood sample taken in your doctor’s office and sent to a commercial laboratory or a research testing facility. Most people have it done by a commercial lab. During testing, the genes are separated from the rest of the DNA, and then they are scanned for abnormalities.

Often, the type of genetic testing that's done and the specific genes being tested dictate whether testing in a research setting is possible. Research labs tend to perform free and anonymous testing. But they may provide limited results or require multiple family members to participate. In addition, testing results may not be available for many months or years, and sometimes they're not available at all.

In the United States, Myriad Genetics performs all commercial BRCA1 and BRCA2 testing. They report results within a month. (Abnormalities in other genes have been associated with breast cancer risk. Right now, these appear to be a less common cause of breast cancer than BRCA1 and BRCA2 mutations, although research is ongoing. If you want to be screened for those, talk to your doctor and genetic counselor about where to be tested.) The cost of the BRCA test ranges from about $300 to $3,000, depending on whether you get the limited test, in which only a few areas of the gene are evaluated, or the full test, in which hundreds of areas are examined on both genes.

In 1988, the U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) to ensure quality standards and the accuracy and reliability of results across all testing laboratories. Genetic testing should be performed by a CLIA-approved facility. (Myriad Genetics is CLIA-approved.)


Popular posts from this blog

1914 Germany Afrikaner farmer Agreement

thank you Etienne 
translated from Afrikaner to EnglishTo all the people of the white race all over the world, most of all to the German nation: This is an important agreement Concerning the South African Boer people and the German nation. It has to do with an agreement between the Boer rebellion and the German troops in Southwest Africa. The Boer rebellion were lead by leaders of the Afrikaaner nation (General Manie Maritz, General SG Maritz, General Koss Delarey) and who’ll be fought against the English in the Second Anglo-Boer war from 1899 to 1902, where the Afrikaaner nation under hun president In Paul Kruger ulcers completely humiliated by the English when ze ulcers forced to sign the Treaty of Vereeniging in 1902. The atrocities committed against the Boers in the Concentration camps ulcers horriffic to say the least, and at least 30 000 Boer women and Children Were driven from hun farms Which Were torched under Lord Kitchener’s Scorched Earth policies. The attached files are an ima…

MS-13 and Los Zetas Drug cartels stealing millions of barrels of oil and taking over control of the drug trade.

Los Zetas vs Ms 13 from Los Zetas is an armed criminal gang that operates as a hired army for the Gulf Cartel. The group is believed to be led by Heriberto “The Executioner” Castanon. Los Zetas, the Ninth CartelTuesday, May 18, 2010 |  Borderland Beat Reporter Buggs

Major pedophile Somali-Muslim sex gang busted in Minnesota and Tennessee.

In a series of arrests carried out Monday morning in the Twin Cities and Nashville, Tennessee, federal and local authorities broke up a human trafficking ring that provided underage prostitutes. A federal indictment unsealed Monday morning in Nashville details the sex trafficking operations of 29 Somali men and women tied to the Somali Outlaws, Somali Mafia and Lady Outlaws gangs, which are all connected and based in Minneapolis. Of the 29 indicted, 12 were arrested Monday morning in the Twin Cities, eight in Nashville and six were already in jail in various locations. Three remain at-large and wanted.MORE

 FBI-2011 National Gang Threat Assessment 2011 National Gang Threat Assessment – Emerging Trends
view printable version (pdf) The gang estimates presented in the 2011 National Gang Threat Assessment (NGTA) represent the collection of data provided by the National Drug Intelligence Center (NDIC) through the National Drug Threat Survey, Bureau of Prisons, State Correctional Facilities, …