Genomic Health, LabCorp, DIANON Systems

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IT WAS A SPECTACULAR DEBUT for a Northern California company now developing technology to allow genetic analysis of tissue blocks as a way to classify tumors.

The company is Genomic Health, Inc., based in Redwood City, California. It is developing proprietary technology which uses “high-through-put analysis of fixed paraffin-embedded tissues to obtain and clinically validate genomic information in large-scale clinical trials.”

At the American Society of Clinical Oncology (ASCO) meeting in Chicago earlier this month, several presentations were made about clinical studies which attempted to classify individual tumors based on analysis of tissue blocks using Genomic Health’s technology. In one study reported at ASCO, Melody Cobleigh, M.D., Director of the Breast Center at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, looked at 79 breast cancer patients diagnosed between 1979 and 1999. Each patient had 10 or more cancerous lymph nodes, a sign of aggressive cancer.

Cobleigh searched for 185 genes related to cancer. She was able to identify that, in patients with three specific genes activated, the cancer was unlikely to metastasize. She also identified two genes that were associated with poor prognosis. Cobleigh and her team analyzed patients’ tumor tissue that had been preserved in paraffin blocks and stored at the hospital.

Cobleigh did a similar study with two other sets of patients and got the same type of results. To validate the test, Cobleigh has already launched a larger study of breast cancer patients using tissue samples collected by international research cooperatives. “If our results are validated, we will have the test in a clinic in a year,” predicted Cobleigh.

For the pathology profession, the technology under development at Genomic Health has two impacts. First, it can allow pathologists to make a more detailed diagnosis about specific types of cancer, to help physicians target care as appropriate. Second, it means the archives of tissue blocks stored by pathology groups throughout the nation will have greater value, both clinically and financially.


IN RECENT WEEKS, Laboratory Corporation of America has seen a small exodus of top-performing sales representatives from its recently-acquired DIANON Systems business unit.

These multiple resignations were apparently triggered by an ultimatum that the reps involved needed to sign the LabCorp sales contract and non-compete agreement. Also gone is Martin Stefanelli, who was DIANON’s Vice President of Sales prior to the company’s acquisition by LabCorp.

Because many sales reps who resigned recently were DIANON’s leading producers, informed speculation is that a new company is under development. This start-up will offer anatomic pathology services and will hire a core group of ex-DIANON employees.

THE DARK REPORT considered the DIANON sales team to be one of the company’s “crown jewels.” LabCorp has to be disappointed at how rapidly this asset is dispersing.


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