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Genomic Health to Present Multiple Abstracts at ASCO on Oncotype DX

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Genomic Health is planning to present several abstracts on its Oncotype DX test at the American Society for Clinical Oncology's annual meeting later this month, including data from studies on the test's ability to detect recurrence of triple-negative breast cancer and male breast cancer.

ASCO accepted two abstracts — titled "Genotypic characterization of phenotypically defined triple-negative breast cancer," and "Molecular characterization of male breast cancer by standard quantitative RT-PCR analysis" — for presentation at its annual meeting at the end of the month in Orlando, Fl.

According to Genomic Health, the study focusing on male breast cancer is the first large genomic study of its kind. The study will analyze samples from 347 male and 82,434 female breast cancer patients using the Oncotype DX Recurrence Score.

At the ASCO meeting, Genomic Health will also present preliminary results from the QUASAR validation study, which met its primary endpoint to predict the likelihood of post-operative disease recurrence in patients with stage II colon cancer. However, the test did not meet a second endpoint using a set of genes to predict which patients are likely to benefit with post-operative 5-fluorouracil/leucovorin treatment [see PGx Reporter 04-15-2009].

Based on these results, Genomic Health is planning to launch the test by 2010. Full results of the QUASAR validation study will be available May 14, the company said, since ASCO has highlighted it as a "noteworthy abstract."

Altogether, Genomic Health and independent researchers will be presenting seven abstracts on Oncotype DX at the ASCO meeting, which signals steady advancement toward the company's previously stated goals of expanding the indication of its flagship product into oncology markets beyond breast cancer, such as renal cell cancer, colorectal cancer, prostate cancer, and DCIS.

Also in early-stage development is an Oncotype DX-based renal cancer test, which Genomic Health is developing in collaboration with Pfizer.

"This program is in early-stage development," Brad Cole, Genomic Health's chief financial officer, said during a call last week announcing first-quarter revenues. "We have established the feasibility of gene expression in renal carcinoma using our Oncotype DX technology and are on track to start our initial gene identification study later this year." During the first quarter, Genomic Health received $500,000 in contract payments from Pfizer for this collaboration.

Breast Cancer

Even though Genomic Health is trying to grow Oncotype DX into other disease areas, its main revenue earner is its breast cancer recurrence test, which was launched in 2004. "Our first priority and most important near-term opportunity remains the growth of our Oncotype DX breast cancer franchise," Genomic Health CEO Kimberly Popovits told investors and analysts during the earnings call.

With steady continued adoption of the breast cancer-recurrence test and reimbursement coverage for 90 percent of the applicable market, Genomic Health is currently focused on increasing adoption of the test in international market. The company is currently receiving breast cancer samples for Oncotype DX from more than 40 countries.

Last month, the company presented positive results from an independent, multi-center study of Oncotype DX in Japanese breast-cancer patients. "This was the first study to analyze the utility of the Oncotype DX breast cancer test in a specific ethnic population," the company said in a statement. Validation of Oncotype DX's use in Japanese patients will certainly help Genomic Health market the test in the country, as the company focuses on increasing adoption of its breast cancer-recurrence test in markets outside the US. [see PGx Reporter 04-29-2009].

"It's very early days with the work that we were doing in Japan," Popovits said in the call.

"The study was a great first step in identifying that the Recurrence Score, in fact, would work for that specific population and what we do know is that the reimbursement tap in Japan is one that will probably take some time and that will require a national coverage decision," she added. "We've got people on the ground, they are working on that now but [we] wouldn't expect to see that for probably several years."

In Japan, personal medical services are paid through a universal healthcare insurance system, in which self-employed people, students, and those without insurance are covered by their local governments, and corporate employees are covered by their employers.

Financials

"As we continue to invest in the worldwide commercialization of Oncotype DX for breast cancer, prepare to launch our colon cancer test, and advance research in the development pipeline we remain focused on moving our organization toward profitability," Cole said.

In the first quarter ended March 31, Genomic Health reported total revenues of $33.9 million, a 45 percent increase over the year-ago period. The company also delivered more than 11,000 test results in the first quarter, compared to 9,000 results in the comparable period of 2008.

The company does not yet break out international sales figures for the Oncotype DX breast cancer recurrence test. "I think until it’s a significant portion of revenue — certainly well above 10 percent — we probably won't break it out separately, and it's well below 10 percent today," Cole said during the earnings call.

Genomic Health's net loss decreased by 30 percent year-over-year, from $6.6 million in the first quarter of 2008 to $4.6 million in the current quarter. As a result of the company's increasing focus on expanding Oncotype DX's use in various cancer markets, Genomic Health's R&D expenses increased 34 percent to $8.6 million from $6.4 million, while its SG&A spending increased 27 percent to $22 million from $17.3 million.

The firm finished the quarter with cash, cash equivalents, and short-term investments of $53.4 million.

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