science and business of dna diagnostic

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.