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Genomic Health Expands Oncotype DX Franchise Into Spain, Portugal

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Originally published April 6.

As part of an effort to globally expand the Oncotype DX franchise, Genomic Health last month added two more countries to a growing list of international markets in which the breast cancer test will now be available.

The exclusive distribution agreement with Palex Medical, a distributor of medical diagnostic services and devices in Europe, will bring Oncotype DX to breast cancer patients in Spain and Portugal.

Oncotype DX measures the expression of 21 genes in a breast cancer patient's tumor and generates a Recurrence Score that quantifies the likelihood the patent will benefit from chemotherapy and the chance that the patient's disease will recur. Earlier this year, Genomic Health expanded Oncotype DX's indication as a tool for predictive recurrence risk in colon cancer.

Genomic Health previously said that this year it plans to grow its “presence and investments” for Oncotype DX in Asia, Europe, South America, and Canada (PGx Reporter 05/14/08).

The company has previously disclosed business relationships with pharmaceutical partners in Turkey and a partnership with GeneKor to distribute Oncotype DX in Greece. Additionally, SRL, the exclusive distributor of Oncotype DX in Japan, has been marketing the diagnostic in the region since 2007 (PGx Reporter 04/29/09).

According to the Genomic Health, as of December, more than 8,000 physicians have ordered more than 135,000 Oncotype DX breast cancer tests in more than 55 countries. The test was launched in the US in 2004.

Genomic Health's agreement with Palex was announced in conjunction with data presented at the European Breast Cancer Conference.

At the meeting, the company presented a study (abstract #387) analyzing the disease prognosis of women in Europe and the Middle East with low estrogen receptor-positive breast tumors and low Oncotype DX Recurrence Score results.

The study showed that "patients with tumors that fall into this category exhibit a good prognosis and minimal, if any, chemotherapy benefit," Genomic Health reported. "These results build upon previous results and illustrate that the Recurrence Score incorporates other important biological pathways beyond ER that provide clinically meaningful information."

In another study (abstract #386), researchers "showed that the less common histologic subtypes of invasive, ER-positive breast cancer are characterized by different gene expression profiles as measured by the Oncotype DX test." According to Genomic Health, this study provided additional evidence that Oncotype DX "is a useful tool" for characterizing the biology of a breast cancer tumor.

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