Thursday, July 3, 2008

How We See It

Context vital for genetic test results

By Mass High Tech Staff

Genetic testing holds such promise in the medical field that testing companies have sprung up all around the country in recent years. Unfortunately, the market they are looking to serve may not be ready for them.

Last month, California issued a letter to 13 companies that conduct genetic tests for individuals to cease testing California residents until they are properly licensed under Golden State law. Among those companies were local firm Knome Inc., which offers a $350,000 complete-genome screening, and 23andMe Inc., a California firm co-founded by Anne Wojcick (the wife of Google Inc. co-founder Sergey Brin) that offers $1,000 gene-specific tests.

One of the problems cited is that these companies aren’t required to gain U.S. Food and Drug Administration approval for their tests, simply an OK from the Centers for Medicare and Medicaid Services that the tests work reliably. Critics suggest that a reliable test for a certain gene associated with a disease such as cancer isn’t a clinically valid piece of information for a patient to determine health risk or disease likelihood, particularly without a doctor’s knowledge about what such a test result means.

While we applaud efforts to put more information in the hands of patients, doing so without providing enough context for information to become useful creates more fear than good and will ultimately lead too many people to jump to the worst conclusion.