The Science and Business of DNA Diagnostic Testing

Andrew Pollack has an good story in today's New York Times that covers advances in DNA testing for diagnostic purposes -- it's becoming more and more widespread, and profitable (this is related to my cover story in this Sunday's NY Times Magazine). His story raises, once again, questions about patents, profits and science, and the impact this has on the cost and quality of the healthcare people get in exchange for their money and genetic samples (which this science depends on).

Pollack says the industry of genetic testing is now estimated at $5 billion and growing by 25 percent annually, and that the FDA is starting to wonder whether it should regulate these tests (took them long enough!). Pollack's piece opens with a woman who paid $3500 for a genetic test that found that "her cancer probably would not come back even if she skipped chemotherapy. "

"Traditionally regarded as a low-profit, poor cousin of prescription drugs, diagnostic tests are emerging as high-profit products in their own right ... the new tests are expensive, often patent-protected and are marketed directly to doctors or in some cases patients instead of to medical laboratories ... But the trend toward such high-priced tests, many of them not yet covered by insurance, is raising concerns in some quarters that diagnostics could become a new contributor to rising health care costs — while increasing the gap between people who can afford good health care and those who cannot ... Such tests are either now available or being developed for purposes like detecting cancer early, monitoring heart transplants and choosing which drugs might work best to treat cancer, AIDS, or heart disease."

Some makers of these tests are making the argument that regulation of their products would "make it uneconomical to develop many tests, which have smaller sales than drugs. " But when there's this kind of money involved, and people are relying on these tests to decide whether they should bypass chemotherapy, somebody better make sure those tests actually do what they claim to do.