Who should control knowledge of your genome?

A Congressional investigation has brought into sharp relief some of the political implications of genetic testing.
Written by Dana Blankenhorn, Inactive

A Congressional investigation has brought into sharp relief some of the political implications of genetic testing.

Rep. Henry Waxman and his House Committee on Energy and Commerce have sent letters to the leading makers of genetic testing kits -- Pathway Genomics, Navigenic, and 23andme -- as the first step in an investigation of the direct to consumer (DTC) genetic testing industry.

This followed the FDA's decision to send Pathway a letter demanding it show it either FDA approval of its tests or its reasons why such approval is not necessary.

This was prompted by Walgreens and CVS plans to offer the Pathway test in their stores. Pathway already sells its test online.

The Pathway test costs just $30 and involves collecting a bit of saliva, then sending it to the company's lab.

(And to think just last month our Boonsri Dickenson was writing about $99 tests and her own experience with the $999 version, which said she was at risk for macular degeneration later in life.)

The investigations have sparked a hair on fire moment for the industry, with people like Andras Pellionisz (above) of HolGenTech rushing to the microphones to condemn big government.

"Consumers must ask, 'whose genome is it anyway?'" Pellionisz says.

His concern is that any restriction on Direct To Consumer (DTC) or Over The Counter (OTC) genetic testing will give foreign competitors like DeCodeMe of Iceland and Korea's DTC Genome Testing institution (backed by Samsung) a leg-up on a lucrative market.

That may be true. But there are also some serious questions to be asked, questions that have not been asked yet, before we make genetic tests as ubiquitous as home pregnancy kits:

  1. How useful are they, really -- All of us have DNA which shows how we might die. Are these kits just creating needless panic?
  2. How accurate are they -- There are reports of cancer-free women ordering mastectomies because there is breast cancer in their family history already.
  3. Are we ready yet -- Scientists don't yet know what a complete genetic test means. Given that reality most of what a test delivers will be as useful as a palm reading.

It's true that you can sell anything you want to people if you don't claim it's medicine. But genetic tests are medicine.

Even if the terms of service for 23andme prohibit sharing the data with your doctor, people will share the data with their doctors, as Steve Murphy of GeneSherpas recently noted. What other reason is there for getting the test?

Pellionisz is right about one thing. It may be way too late to put this one back in the box. Al Gore helped launch Navigenics. And 23andme co-founder Anne Wojcicki is also Mrs. Sergey Brin, as in Google co-founder Sergey Brin.

The industry has also been getting on TV, with celebrities like Larry David getting their DNA tests read out on the George Lopez Show.

It's not the "consumer wanting to know what's going to kill me" market that should be the political issue in any case. It's the identification market.

This month the full U.S. House approved legislation that will pay states to collect DNA samples on all those people arrested for any crime, as a crime-fighting measure.

That's where the money is. That's where the politics is.

So where do you stand on the issue. Want your DNA tested? Want to be able to resist having it tested? It's your DNA -- who should know about it?

This post was originally published on Smartplanet.com

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