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Genomic Health Expands Oncotype DX Uses; Launches Education Campaign

Genomic Health this year plans to launch a string of studies to expand the indication for its Oncotype DX breast cancer-recurrence assay and launch an online campaign to educate women about how the early-stage breast cancer test may be an option for them.
Speaking to investors at last week’s JPMorgan Healthcare Conference in San Francisco, Genomic Health CEO Randy Scott discussed plans to advance Oncotype DX into a number of cancer indications, including colon and kidney cancer; launch a second-generation breast cancer recurrence test; and continue to validate the assay in large-scale studies such as the National Cancer Institute’s TAILORx trial.
Launched in 2004, Oncotype DX is designed to help assess breast cancer recurrence and chemotherapy benefit in tamoxifen-treated patients with early-stage, node-negative, estrogen receptor positive breast cancer.
Genomic Health plans to expand this indication to node-positive breast cancer, is studying its utility in gauging chemotherapy benefit when women are at a precancerous stage, and is trying to learn whether it will help determine if patients will respond to treatment with aromatase inhibitors.
Expanding Indications
Colon cancer will likely be the next indication for which Genomic Health will launch a genetic test.
In 2006, the company began developing a colon cancer test based on Oncotype DX’s RT-PCR-based platform. Genomic Health is evaluating this test in more than 3,000 patient samples with the National Surgical Breast and Bowel Project and other clinical partners.
According to Scott, the colon cancer test will likely be validated this year and is expected to launch in 2009 or 2010, depending on FDA clearance requirements.
Oncotype DX’s technology is also the foundation for Genomic Health’s collaboration with Pfizer to develop a diagnostic for kidney cancer [see PGx Reporter 01-09-2008].
At the conference, Scott also announced the company’s plan to study whether Oncotype DX can help determine which women will benefit from treatment during a precancerous stage called ductal carcinoma in situ, or DCIS. The condition, often called Stage 0, “is a difficult problem for many women trying to decide how aggressively to treat and use therapy,” Scott said during the conference.
Oncotype DX currently measures the activity of a 21-gene panel in patient’s tumor samples and determines a recurrence score ranging from 0 to 100. A higher score indicates a greater risk of recurrence. The company is in the process of determining whether it needs to expand the gene panel for the DCIS indication. If new genes need to be added to the panel, the development for this test will be slower, Scott noted.
Node-positive breast cancer patients might also benefit from Oncotype DX testing. During the American Society of Clinical Oncology’s annual meeting last year, the company presented data showing that Oncotype DX can identify women with hormone positive, HER2-negative breast cancer with up to three positive auxiliary nodes.
In keeping with the latest treatments for breast cancer, Genomic Health is conducting a large clinical trial to find out whether Oncotype DX can predict which patients will benefit from treatment with aromatase inhibitors. The reason behind this is that “tamoxifen now is going down in utilization for post-menopausal women and aromatase inhibitors are taking over,” Scott noted. Results from this study are slated to be released later this year.
According to Scott, the company also plans to continue making improvements to the platform on which Oncotype DX is based, and intends to develop a second-generation breast cancer-recurrence test.
He added that the company this month will begin providing quantitative expression reporting for estrogen and progesterone receptors with Oncotype DX testing. This decision was based on a series of clinical trials the company conducted last year “showing that quantitative information adds value to physicians and patients,” Scott said.
“In the world of breast cancer there is no ER-negative breast cancer,” he said. “All breast cancer is expressing the estrogen receptor; it’s just an issue of how much.”
Providing physicians quantitative data about ER and PR is important so “physicians can know what is the likelihood of response to hormonal therapy and [whether] they can factor that into the treatment paradigm.”
In providing this additional data, Genomic Health said it will increase its customer-service and medical-affairs staff to help facilitate discussions with physicians and manage any potential errors in ER and PR analyses.
I’ve Heard About This Test
To date, Genomic Health has been urging doctors to prescribe the test and insurers to pay for it. In the first three quarters of 2007, Genomic Health said that use of the test in the US swelled 60 percent while revenue from it more than doubled.
According to Genomic Health, more than 6,600 physicians in the US have used Oncotype DX since it was cleared for marketing. Additionally, more than half of all insured individuals in the US are covered for the test. The company negotiated contracts with Medicare and large private insurers, such as United, Aetna, WellPoint, Cigna, Kaiser Permanente, and a number of Blue Cross Blue Shield plans.
Oncotype DX also received a boost when the American Society of Clinical Oncology and the National Comprehensive Cancer Network updated their treatment guidelines to recommend testing with Oncotype DX [see PGx Reporter 10-31-2007; 01-02-2008]. 

“We’re moving more and more now toward direct-to-patient education. This is not something we’ve done a lot of in the past.”

Genomic Health’s focus, now with the insurance piece in place and adoption rates up, is to make Oncotype DX the standard of care among oncologists treating early-stage breast cancer. In order to do this, Scott said the next step for the company is to directly target patients with early-stage breast cancer.
Since newly diagnosed patients are most likely to turn to the internet for supplemental information, Genomic Health has launched as the main component of its targeted direct-to-patient education effort, a company spokesperson told Pharmacogenomics Reporter this week. The website offers information about Oncotype DX through a patient’s diary chronicling her experience using the test. The site also allows women in similar situations to interact through an online forum.
“We’re moving more and more now toward direct-to-patient education,” Scott said. “This is not something we’ve done a lot of in the past.”
The spokesperson emphasized that the company’s direct-to-patient efforts are different in scope and intent from the pharmaceutical industry’s direct-to-consumer advertising campaigns aimed at the general market. Genomic Health's cautious approach is understandable given previous criticism that some direct-to-consumer campaigns have attracted in the pharma industry.
Pharma-style direct-to-consumer advertising for genetic tests is a fairly new concept for the diagnostics industry. However, the market has been sensitive to company-sponsored “information campaigns” that smell more like thinly veiled marketing ploys.
For example, Myriad Genetics experienced a strong backlash last fall for its national TV campaign for its BRCA 1 and 2 tests. The physician community felt that their practices would not be able to sustain the influx of requests for BRCA testing as a result of Myriad’s ads [see PGx Reporter 09-12-2007].   
Although Genomic Health’s spokesperson was careful to distance its targeted patient education efforts for Oncotype DX from broader DTC campaigns, during the conference, Scott said that the company’s aim was to get early-stage breast cancer patients “to walk in the door and say to their physician, ‘I’ve heard about this test Oncotype DX.’”
The company plans to encourage more educated physician/patient conversations surrounding Oncotype DX through syndicated programs, videos, search-engine optimization, and through online communities like Facebook.
“The critical question for us is that [although] we’ve gotten significant physician adoption, only about one-third of the market is penetrated in terms of the use of Oncotype DX,” Scott said. “How do we move this to standard of care? How do we get physicians to think differently and shift the paradigm to say, fundamentally, ‘I need to look at the molecular information first, and then I’m going to add the rest of the clinical information to that before I make my treatment decision?’”

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