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Firm Carves New Model in Biotech Research
CEO Kevin Krenitsky, with BioServe's cryotanks of tissue samples, joined the biotech firm after helping it buy a repository of human DNA samples.
(By Susan Biddle -- The Washington Post)
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Last year, the Government Accountability Office investigated four companies that sold genetic tests directly to consumers, including Suracell, which markets its kits through spas, physicians and online for individuals to identify genes that may contribute to obesity.
The test results purchased by GAO investigators, the agency said, "mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers." Suracell executives did not return calls last week seeking comment.
At a Senate Special Committee on Aging hearing last year, SuraCell founder Kristopher King defended his company's work. The "program is designed for informed clients," he said in prepared remarks, and "is recommended for consumers with the oversight of a licensed physician, genetic counselor or health care practitioner."
Though BioServe is the exclusive testing laboratory for Suracell, Krenitsky said it provides the results only to physicians, who are responsible for how they are used.
Among researchers, the lack of high-quality specimens has become a growing problem, particularly as the number of clinical trials and epidemiology studies has grown, said Jim Vaught, deputy director of the National Cancer Institute's office of biorepositories and biospecimen research.
So has concern about the ethics and methodology of companies in the field, he said. Earlier this year, the National Cancer Institute began holding forums aimed at developing "best practices" for the collection, storage and use of bio-specimens.
Next month, BioServe plans to launch the latest in a series of new diagnostic products -- specimens that contain variations that could help researchers identify the genetic calling card of breast cancer.
"I do have a lot of ideas how to market DNA [tests] in addition to doing our own research," Modali said, and the ones the company has employed are paying off. So far, he said, Bioserve's revenues have increased 150 percent this year.
Staff researcher Richard Drezen contributed to this report.
