The growing market for human tissue samples operates in several different ways. Some samples come from patients who have had surgery or biopsies. In the past, such tissue was often taken from patients and used for research without telling them. Now, hospitals and laboratories usually ask patients to sign a release saying their tissue may be used in research, though patients might easily overlook the consent form in the flurry of paperwork they must sign upon admission to the hospital.
Another source of tissue is companies established specifically to obtain samples for research. So far, it's a cottage industry, but it's growing. One such company is Ardais Corp. in Lexington, Mass. It has devised what it says is a careful consent procedure, which it uses to get 25,000 to 30,000 samples per year from each of several medical centers. They include Duke University Medical Center in Durham, N.C., and Beth Israel Deaconess Medical Center in Boston.
Ardais licenses the use of the tissue to researchers. "This is not parts for sale," says Eric B. Gordon, Ardais' president and CEO. The samples are frozen within an hour after being removed from patients, and shipped to Lexington. About half of the samples are from cancer patients, and the rest cover a wide range of other diseases, Gordon says. He won't say what the company charges except to acknowledge that the rates are higher for commercial customers than for university laboratories.
Many other biotechnology companies have decided to start their own tissue collections. San Diego's Sequenom Inc. is one of them. "Sometimes, you can buy it, but you may have a very, very specific question or hypothesis, and then you need very special samples," says Andi Braun, Sequenom's chief medical officer. Companies typically establish a collaboration with an academic researcher who will find patients with the desired characteristics and obtain the tissue samples, Braun says.
Another reason companies might start an in-house collection is to protect their patent rights, Braun says. When companies buy tissue, they may be required to sign an agreement saying they will share with tissue suppliers the patent rights to new products or a share of the profits of anything developed using the tissue. Should the research succeed, such a provision could ultimately cost companies tens or hundreds of millions of dollars. "If you have to borrow or collaborate, you have to give away so much intellectual property that at the end of the day, it's not worthwhile to do it," he says. An alternative is to buy samples outright, but that can cost $50 to $1,000 per sample, Braun says. And an experiment might require hundreds of samples, meaning the costs of the tissue alone could be in the millions.
Despite the expense, research on tissue samples can often substitute for research on human subjects or laboratory animals, and it's far cheaper than either. And because so much information is collected on each sample, bits of the tissue can be used for many different experiments. That saves time and money because researchers don't need to collect a new group of patients each time they begin a new study. They simply use the samples they have on hand.
By Paul Raeburn in New York