Clinical diagnostics in a Starbucks package

Written byBrendan Maher

| 2 min read

The __New York Times__ linkurl:has an interesting business story;http://www.nytimes.com/2006/04/13/business/13diagnose.html 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?

Clinical diagnostics in a Starbucks package

The Scientist ARCHIVES

Become a Member of

Meet the Author

Brendan Maher

Related Research Resources

Why Do We Feel Butterflies in the Stomach?

Research Resources

Podcasts

Webinars

Videos

Infographics

eBooks

Best Practices for Precise Pipetting

Long-Read RNA Sequencing Reveals a Regulatory Role for Splicing in Immunotherapy Responses

Research Roundtable: The Evolving World of Spatial Biology

Exploring the State of the Art in Gene Editing Techniques

Products

Product News

LabVantage Solutions Awarded $22.3 Million U.S Customs and Border Protection Contract to Deliver Next-Generation Forensic LIMS

Evosep Unveils Open Innovation Initiative to Expand Standardization in Proteomics

SPT Labtech and Alithea Genomics Collaborate to Automate Ultra Sensitive Single-Cell Transcriptomic Workflows

OGT expands MRD detection capabilities with new SureSeq Myeloid MRD Plus NGS Panel