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Genomic Health Officials Discuss Continued Growth of Oncotype DX Tests

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During a call to discuss third quarter earnings, Genomic Health officials said that more than three hundred doctors had ordered its Oncotype DX prostate cancer test, many of whom have placed repeat orders.

Company officials have previously said that the prostate cancer test, which was launched last spring, may represent the biggest market opportunity for the company to date (PGx Reporter 5/15/2013). Since commercializing the multi-gene expression diagnostic, 70 percent of the urology customers that the company targeted, including more than 300 physicians, have ordered it, according to Brad Cole, Genomic Health's COO. Cole added that 40 percent of these doctors have placed repeat orders.

The Oncotype DX prostate cancer test analyzes the expression of 17 genes within four biological pathways to gauge prostate cancer aggressiveness. The test reports a genomic prostate score from 0 to 100; the lower the score the more certain a patient can be that they can avoid treatment and continue with active surveillance. Prostate cancer patients who are deemed to be at very low risk, low risk, or intermediate risk of progressing are eligible to be tested with the Oncotype Dx test. If, based on standard clinical measures, a person's prostate cancer is considered high risk, then he is not a candidate for Genomic Health's test.

"There was a real need in this market of determining lower risk and low risk," Popovits told investors during the call, explaining that the Oncotype DX prostate cancer test was specifically designed to look at this population.

It is estimated that each year 23 million men undergo testing for prostate specific antigen, a protein produced by the prostate gland that increases when a man has prostate cancer. Additionally, one million men get a prostate biopsy annually, while 240,000 men end up with a diagnosis for prostate cancer, and around 30,000 die from the disease. Although most of the men diagnosed with prostate cancer end up receiving surgery or radiation treatment, as many as half of these men will probably not progress, and their disease isn't life threatening.

According to Cole, the company believes that as the prostate cancer test gains wider adoption, the proportion of doctors placing repeat orders will also increase. "There is a big need here," Cole said. "We're trying to think differently about active surveillance … So, this [test] has been a very welcome addition in this very low-risk population."

Researchers from Genomic Health published the abstract of an analytical validation study on the prostate cancer test in BMC Genomics in October. Researchers led by Genomic Health's Dejan Knezevic reported that the test could analyze as little as 5 ng of RNA.

The investigators gauged reproducibility and precision of the test by testing 10 prostate cancer samples across multiple instruments, different reagent lots, days, and RNA input levels. "The standard deviations for analytical precision and reproducibility were 1.86 and 2.11 GPS units, respectively," Knezevic and colleagues reported in the abstract.

During the quarter, Genomic Health increased its SG&A spending to $40 million, compared to $33.6 million during the third quarter of 2012. This increase, according to Genomic Health CFO Dean Schorno, was due to efforts to commercialize the prostate cancer test. Cole added during the call that Genomic Health is planning to increase the size of its urology sales force in 2014 to drive further adoption of the test.

Genomic Health officials attributed the 12 percent year-over-year revenue growth during the quarter — to $66 million from $58.6 million in the third quarter of 2012 — to strong international penetration, encouraging uptake of its prostate cancer test, and greater adoption of the Oncotype DX test in the node positive and node negative invasive breast cancer market.

Approximately 15 percent of Genomic Health's $65.7 million in product revenues came from the international market. International product revenues jumped by 25 percent to $10.1 million during the third quarter.

The UK's National Institute of Health and Care Excellence issued a recommendation in September backing Oncotype DX as a tool to help doctors decide whether a woman with ER-positive, lymph node-negative, HER2-negative breast cancer, deemed to be at intermediate risk by standard assessment tools, is at risk for disease recurrence and needs chemotherapy (PGx Reporter 9/25/2013).

Although NICE looked at other prognostic assays, the group only recommended Oncotype DX. Genomic Health officials believe the NICE recommendation, in addition to inclusion in numerous other guidelines, will help the company stave off competition for Oncotype DX in the increasingly crowded breast cancer prognostic testing market.

In an effort to continue to grow the market for its flagship Oncotype DX breast cancer test, Genomic Health is expanding a targeted advertising campaign to reach the estimated two-in-five women with invasive breast cancer in the US who have not used the test. The company is utilizing online marketing, via YouTube, social media, and its own websites, to educate healthcare providers and patients about the test. "We're encouraged by the impact of these targeted efforts and plan to expand the program for additional targeted regions," Popovits said.

Highlighting the numerous validation studies, strong reimbursement, and guidelines recommending use of Oncoytpe DX to guide treatment strategies for early-stage breast cancer patients, Popovits said that it was "imperative" that "all eligible patients have the opportunity to consider Oncotype DX before making a treatment decision."

For the rest of the year, Genomic Health will continue to build the evidence base around its various Oncotype DX tests. The company is conducting a second study on its prostate cancer test evaluating biochemical recurrence and adverse pathology in low-risk patients, a large study involving ductal carcinoma in situ patients, as well as another next-generation sequencing study using paraffin-embedded tissue.

Meanwhile, Genomic Health's study on a test that can predict whether Stage III colon cancer patients will benefit from oxaliplatin treatment experienced a setback. Before moving this test into the validation phase, the company determined that certain markers it was studying weren't as promising as previously thought.

As such, the company will not launch this test next year as planned. Steve Shak, Genomic Health's executive VP of R&D, said that researchers developing this test will probably have to identify new genes associated with oxaliplatin benefit in colon cancer patients and it may be more than a year before a new validation study is launched.

Separate from this predictive colon cancer test, revenue for the Oncotype DX prognostic colon cancer assay grew by 25 percent year over year in the US, representing nearly 3 percent of total product revenue. "We're now approximately 17 percent penetrated in this market," Schorno said during the call.

In the third quarter, Genomic Health delivered more than 21,790 Oncotype DX test results, up 21 percent from more than 18,030 test results delivered during the same period in 2012. To date, the company said it has delivered 400,000 results to patients using its various Oncotype DX tests for breast, colon, and prostate cancer.

The breast cancer test, however, remains the firm's best-selling product. "We continue to receive more breast cancer samples each day than any other lab in the US," Popovits said.

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