Gene-testing

Gene-testing

Сообщение Akvinat » Пт июн 27, 2008 6:29 am

Gene-testing firms face legal battle

The state of California is clamping down on companies that offer direct-to-consumer genetic testing in a move that threatens the burgeoning industry. Meredith Wadman looks at a grey area in US regulation.

Meredith Wadman


Last Wednesday, as California governor Arnold Schwarzenegger prepared to tell a biotechnology industry convention in San Diego that his state “is one of the best places to set up shop”, Kári Stefansson was opening a letter that had just landed on his desk at deCODE genetics in Reykjavik, Iceland.

The letter read: “It has come to the attention of the California Department of Public Health…that deCODEme Genetics is in violation of California law” for failing to have a clinical laboratory licence in the state and offering genetic tests to consumers resident in the state without a physician's order. It gave deCODE until 23 June to submit a plan showing how it would correct the situation, or face “civil and/or criminal sanctions”.

Stefansson's high-profile company is one of 13 genetic-testing firms that have been targeted during the past two weeks by the California agency with a letter to “cease and desist” selling tests to California's residents. The directive poses a serious challenge to plans for a new era of Internet-based, direct-to-consumer genetic testing. The companies include Californian businesses 23andMe and Navigenics, which have begun marketing test packages based on genome-wide arrays within the past six months, and DNATraits.com, based in Houston, Texas, which counsels prospective parents on the genetic risks faced by their future offspring.

DNA Direct, a San Francisco-based firm founded in 2003 that offers tests for familiar mutations in well-characterized genes such as BRCA1 and BRCA2 , which convey an increased risk of breast cancer, did not receive a letter.

“If these companies were constrained from reaching out to consumers directly, it would certainly cause some near-term difficulty for their business,” says life-sciences analyst John Sullivan at Leerink Swann, an investment bank based in Boston.

During a public meeting on 13 June, Karen Nickel, California's chief of laboratory field services, who wrote the letter, said that consumer complaints had triggered an investigation into 25 companies, of which 13 were ultimately sent letters. Nickel told the meeting: “We [are] no longer tolerating direct-to-consumer genetic testing in California.” Under California law, the companies could be fined up to US$3,000 per day for each violation if there is no “immediate jeopardy” to state residents — and from $3,050 to $10,000 per day if there is.

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Итересно, а какой вред от genetic testing без назначения physician? Кроме упущенной выгоды для physicians.
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Akvinat
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Re: Gene-testing

Сообщение Terrin » Пт июн 27, 2008 6:42 am

Я не знаю. Калифорнийцев жалко. Но компаниям типа деКода эта Калифорния погоды не сделает.
"Старые мосты могут еще пригодиться. Лучше сжечь старые грабли."
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Re: Gene-testing

Сообщение Leia » Пт июн 27, 2008 3:46 pm

А скажите по-русски "в двух словах", о чем эта статья? Что-то не могу даже начать ее читать: знаки мельтешат перед глазами и в слова не складываются... :unknown: (Может, просто шрифт непривычный или не выспалась сегодня?)
Стою на асфальте,
В лыжи обутый,
Наблюдаю закат…

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Re: Gene-testing

Сообщение Akvinat » Пт июн 27, 2008 4:46 pm

Отныне в Калифорнии gene testing можно будет делать только по назначению врача. Не исключено, что не только в Калифорнии.
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