The New York Times has an interesting business story on the growth of high-priced clinical diagnostic tests involving genomic and proteomic technologies. One chief scientific officer praised the makers of Oncotype DX (which rates the risk of breast cancer recurrence based on a panel of 12 genes) for validating their product in the clinic and then placing it ?in a Starbucks package at a high price.? At $3500 a pop, the test apparently appeals to a more exclusive club of health consumer. Even the name DX speaks to me of leather seats, wood paneling, and a temperature controlled cup holder for your latte.

I was a tad surprised that this type of testing has moved so quickly to what another chief executive referred to as ??pharmaceutical-like? profit margins? (although it should be noted, that description was touted at an investor?s meeting). But how could the market be so hot for products that haven?t had a huge amount of testing yet? Well, the article does note that such tests currently don?t require FDA approval and that the companies producing them have largely kept testing proprietary ? essentially a mail order business restricted to the labs where they were developed, a situation that some critics say may make improvements in the methods less likely.

The FDA has declared some intention to regulate the field. The article mentions Correlogic, makers of the embattled Ovacheck, a serum proteomic test for ovarian cancer. Several articles (which we?ll be covering in our May Hot Papers section) pointed to irreproducibility of initial results. The FDA sent a letter, and Ovacheck has yet to make it to market. As the power and promise of pharmacogenetics increases in the next several years, we?ll likely see this issue come up more and more frequently. But whether regulation will be the norm, forcing such tests to prove their worth over existing tests for the same conditions, is still a matter of speculation. Anyone willing to bet a cup of coffee on it?