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Start-Up Pathway Genetics May Sell Genetic Tests in Walgreen's Stores
 
 
  By Andrew Pollack, NY Times, Published: May 10, 2010
 
Genetic tests that assess a person's risk of getting various diseases are heading to the corner drug store.
 
Pathway Genomics, a start-up company, is expected to announce on Tuesday that it will sell such a test through most of the nation's 7,500 Walgreens stores.
 
The tests sold by Pathway, and others by its competitors, look at specific variations in a person's DNA to derive information about their risk of getting diseases like diabetes, heart disease and various forms of cancer. Such tests have until now been sold directly to consumers through the Internet or through doctors' offices.
 
By capitalizing on the foot traffic in drug stores, Pathway hopes to gain an edge on rivals 23andMe and Navigenics, which are older and better known.
 
"It's more consumer awareness than we could get from advertising online," said Jim Woodman, vice president for corporate strategy at Pathway, which is based in San Diego and is privately held.
 
The personal genomics companies appear to have garnered fewer than 100,000 customers combined since starting nearly three years ago. Pathway, which started last summer, will not say how many customers it has.
 
The tests, which generally cost $300 or more, have also stirred controversy. Some genetics experts say the tests cannot provide accurate or significant information because not enough is known yet about the genetic causes of disease. Some critics say doctors should be involved in interpreting the tests. New York State considers these medical tests, not consumer information, and requires a license. Pathway does not yet have one, so its test will not be carried by Walgreens in New York.
 
Mr. Woodman of Pathway said he did not expect the move into drug stores to stir more criticism.
 
What Walgreens will be selling, for a price expected to be $20 to $30, is Pathway's saliva collection kit, packaged in a box that says "Discover Your DNA." But the testing of the saliva will cost extra from $79 to as much as $249, depending on how full a set of tests the consumer orders.
 
Consumers would send their saliva sample, which contains their DNA, to the company's lab. But they would still have to go to Pathway's Web site to order the specific test they want and pay an additional fee. They would also receive the results via the Web.
 
Even at $249 for the full test, in addition to the $20 to $30 for the kit, Pathway's test through Walgreens will be cheaper than the $399 the company charges if the same test is ordered completely online, in which case Pathway sends the consumer a saliva kit that must be mailed back.
 
Jim Cohn, a spokesman for Walgreens, said the chain decided to carry the test because "we recognize that genetic reports are for some becoming a more important component in managing one's health care."
 
Drug stores already carry a variety of diagnostic tests, like those for pregnancy, cholesterol and blood sugar. When some of these tests were introduced, there was controversy about whether consumers could test themselves.
 
Although broader in scope, Pathway's test is not the first DNA-based analysis to be sold in drug stores. Sorenson Genomics began selling a paternity test through Rite Aid stores in late 2007. Sorenson has sold more than 100,000 tests through Rite Aid and other major pharmacy chains since then, according to Jacob Moon, a spokesman for the company.
 
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Start-Up May Sell Genetic Tests in Stores
 
May 11, 2010, 1:54 am
 
Genetic tests that assess a person's risk of getting various diseases are heading to the corner drug store. Pathway Genomics, a start-up company, is expected to announce on Tuesday that it will sell such a test through most of the nation's 7,500 Walgreens stores, Andrew Pollack writes in The New York Times.
 
The tests sold by Pathway, and others by its competitors, look at specific variations in a person's DNA to derive information about their risk of getting diseases like diabetes, heart disease and various forms of cancer. Such tests have until now been sold directly to consumers through the Internet or through doctors' offices.
 
By capitalizing on the foot traffic in drug stores, Pathway hopes to gain an edge on rivals 23andMe and Navigenics, which are older and better known.
 
"It's more consumer awareness than we could get from advertising online," said Jim Woodman, vice president for corporate strategy at Pathway, which is based in San Diego and is privately held.
 
The personal genomics companies appear to have garnered fewer than 100,000 customers combined since starting nearly three years ago. Pathway, which started last summer, will not say how many customers it has.
 
The tests, which generally cost $300 or more, have also stirred controversy. Some genetics experts say the tests cannot provide accurate or significant information because not enough is known yet about the genetic causes of disease. Some critics say doctors should be involved in interpreting the tests. New York State considers these medical tests, not consumer information, and requires a license. Pathway does not yet have one, so its test will not be carried by Walgreens in New York.
 
Mr. Woodman of Pathway said he did not expect the move into drug stores to stir more criticism.
 
What Walgreens will be selling, for a price expected to be $20 to $30, is Pathway's saliva collection kit, packaged in a box that says "Discover Your DNA." But the testing of the saliva will cost extra from $79 to as much as $249, depending on how full a set of tests the consumer orders.
 
Consumers would send their saliva sample, which contains their DNA, to the company's lab. But they would still have to go to Pathway's Web site to order the specific test they want and pay an additional fee. They would also receive the results via the Web.
 
Even at $249 for the full test, in addition to the $20 to $30 for the kit, Pathway's test through Walgreens will be cheaper than the $399 the company charges if the same test is ordered completely online, in which case Pathway sends the consumer a saliva kit that must be mailed back.
 
Jim Cohn, a spokesman for Walgreens, said the chain decided to carry the test because "we recognize that genetic reports are for some becoming a more important component in managing one's health care."
 
Drug stores already carry a variety of diagnostic tests, like those for pregnancy, cholesterol and blood sugar. When some of these tests were introduced, there was controversy about whether consumers could test themselves.
 
Although broader in scope, Pathway's test is not the first DNA-based analysis to be sold in drug stores. Sorenson Genomics began selling a paternity test through Rite Aid stores in late 2007. Sorenson has sold more than 100,000 tests through Rite Aid and other major pharmacy chains since then, according to Jacob Moon, a spokesman for the company.
 
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FDA to look into gene tests to be sold at Walgreen's
 
(Reuters) - U.S. pharmacy chain Walgreen Co plans to start selling genetic testing kits to help people assess their risk for inherited diseases in a move that has already drawn the attention of federal health officials.
 
Walgreen said on Tuesday it plans to start stocking gene testing kits this week made by Pathway Genomics, a start-up company based in San Diego. The deal with Pathway would make it the first to put such tests in the local pharmacy.
 
But the U.S. Food and Drug Administration says it has no record that the test kit was approved or validated by the agency and plans to take a hard look at any claims made by the company.
 
"If a company is making claims about a product that hasn't been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do," Erica Jefferson, an FDA spokeswoman, said in a telephone interview.
 
Many experts say genetic testing kits offer incomplete information, and any results about disease risk, especially for incurable diseases such as Huntington's or Parkinson's, should only be done with genetic counseling that clearly explains the limitations of genetic testing.
 
Several companies -- including Decode Genetics' DeCodeME based in Iceland, 23andME in which Google has invested, and privately held Navigenics -- sell tests that allow people to learn if they have inherited risk for disease.
 
Pathway said in a statement its personal genetic testing kit, the Pathway Genomics Insight Saliva Collection Kit, will be sold at many of Walgreen's nearly 7,500 stores nationwide, for $20 to $30 per kit.
 
It contains a small saliva collection kit, instructions, and a postage-paid envelope that customers can use to send their sample back to the Pathway lab.
 
Then, consumers go on the company's web site, www.pathway.com, to order a customized report about their genetic make up, with prices ranging from $79 to $249.
 
Walgreen said FDA clearance is not required to sell the kit in its stores. The drugstore chain already sells other diagnostic and testing products such as pregnancy tests, paternity tests and drug tests.
 
"There are people who need or want to know more about their genetic history or their genetic makeup," Walgreen spokesman Jim Cohn told Reuters.
 
The chain will not sell the tests in the state of New York because of a state law that considers them medical tests, and not consumer information.
 
Pathway said in a statement the company follows regulatory guidelines that apply to its products.
 
"FDA clearance is not necessary to sell the Pathway Genomics Insight Saliva Collection Kit in retail," the company said.
 
It said the tests are not intended for use in diagnosis, treatment or for the mitigation or cure of a disease -- qualities that would make it an in vitro medical device, which the FDA does regulate.
 
"It does provide information that allows a person to learn about their health to make healthier lifestyle choices," the company said.
 
 
 
 
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