Agendia's MammaPrint test for breast cancer prognosis was launched in the United States last month. In a press release, The Molecular Profiling Institute (MPI), which licensed the test from Agendia, calls MammaPrint "the first commercially available microarray cancer diagnostic that analyzes patients' breast tumors for their individual DNA expression profile." (For more on Agendia, see: Agendia to Market First Chip-Based Test.)

Genomic Health released its Oncotype DX gene expression-based breast cancer prognosis test in 2004. That test tracks the expression levels of 21 genes using RT-PCR (reverse transcription-polymerase chain reaction). (For more, see: Genomic Health Reveals Its Business Plan, and Genomic Tests Hitting the Clinic.)

MammaPrint predicts a patient's likelihood of surviving 10 years based upon a gene-expression signature using 70 genes. A study published in 2002 in The New England Journal of Medicine reported an accuracy level of 96.7 percent for this test.

Besides the MammaPrint test, Agendia also offers a CupPrint test to patients and healthcare professionals in Europe. That test "can assist in determining the primary tumor" in cancer patients with primary tumors of unknown origin, according to the company website. MPI is a specialty reference laboratory formed to apply discoveries from the Human Genome Project to the analysis of individual patients' cancers.

There is widespread agreement that traditional methods of determining which women need the most aggressive therapy for breast cancer are unsatisfactory. It is particularly difficult to decide when patients whose lymph nodes are clean of cancer should still have follow-on therapy. Many more patients receive chemotherapy than actually need it. However, many patients who would have been helped by the follow-on treatment still don't get it.

Both MammaPrint and Oncotype DX are "homebrews" that can only be done by MPI and Genomic Health, respectively. MPI announced that its test costs $3,200. "We believe this fee is reasonable, considering the complexity and accuracy of the test. This amount is low compared to the economic and personal cost of unnecessary treatment or simply not treating a patient at high risk for recurrence," said David Mallery, MPI's executive vice president.

Genzyme Genetics is diving into the diagnostic side of targeted medicine. The company has just signed an agreement with Massachusetts General Hospital and the Dana-Farber Cancer Institute to develop a test for identifying patients most likely to response to epidermal growth factor receptor (EGFR)-targeting cancer drugs.

Last year, researchers at those two Boston institutions reported that mutations in the EGFR gene help predict which patients respond to drugs that target the receptor. Those drugs include such high-profile products as AstraZeneca's Iressa, and Tarceva, marketed by Genentech and Roche.

"Discovery of the EGFR mutations is an exciting scientific breakthrough in a new era of medicine linking diagnostics and targeted therapeutics," stated Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme Corp. focused on performing diagnostic tests in the fields of cancer and reproductive medicine. "Our EGFR diagnostic will assist physicians in identifying the right therapy, for the right patient, at the right time." (For more on Genzyme's oncology aspirations, see: Genzyme's Big Oncology Bet.)

Americans and Russians Share "Booze Abuse Gene." An association between genetic variations in the GABRA2 receptor subtype and risk for alcohol dependence was described in studies of U.S. populations last year. Now, the same gene has been implicated in a Russian population, according to a published study by a Yale School of Medicine researcher. The new findings "help demonstrate that regardless of what different environmental factors in Russia may be at play, the genetic variations still seem to be influencing risk in that population," said Jaako Lappalainen, assistant professor of psychiatry in the Center for the Translational Neuroscience of Alcoholism at Yale, and first author of the study.

Vikram Jog Named XDx CFO. XDx Inc. has named Vikram Jog as its first chief financial officer. Jog comes to XDx from Celera Genomics and Celera Diagnostics. He was vice president of finance for both these divisions of Applera. XDx develops molecular diagnostics for post-surgical heart transplants rejection.

Predicting Risk and Response with Beta Blockers. University of Florida researchers report that patients with heart failure carry genetic variations that can determine whether they will tolerate beta-blocker therapy. In another study, the Florida researchers also found that certain genes influence whether patients will respond to these drugs. The findings were published in Clinical Pharmacology and Therapeutics and Pharmacogenetics and Genomics, respectively. The principal investigator of these studies was Julie Johnson, director of the UF Center for Pharmacogenomics and an executive board member of the UF Genetics Institute.