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Genomic Health Anticipates Breast Cancer Test Growth in Europe, Preps More Data on Prostate Assay

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Originally published May 13.

NEW YORK (GenomeWeb) — Genomic Health said that it anticipates continued adoption of its flagship Oncotype DX breast cancer test outside the US this year, and it is planning to share several studies in coming months supporting the expanded use of that test. Company officials also discussed during a call describing first quarter earnings last week efforts to build the evidence base for, and drive adoption of, its new prostate cancer diagnostic.

Genomic Health Chairman, President, and CEO Kim Popovits said during the call that the firm saw "exceptional international growth" in the quarter for Oncotype DX breast, as well as increased adoption of Oncotype DX prostate, though use of the newer test still represents a fraction of the company’s testing.

According to COO Brad Cole, Genomic Health’s international testing grew 43 percent compared to the same period last year and now represents almost "20 percent of total company test volume." Genomic Health sells its tests in 70 countries and has secured reimbursement coverage for 115 million patients outside the US. Although the Oncotype DX brand is “well-penetrated” in certain key markets, Cole noted that in most geographies, Genomic Health’s tests are at 10 percent penetrance, leaving significant growth opportunities.

According to Cole, the endorsement of Oncotype DX breast by numerous professional guidelines has been central to its international growth. For example, he cited recent updates to Germany's AGO oncology working group guidelines, which he said now recommend Oncotype DX breast as a tool to predict chemotherapy benefit in early-stage hormone receptor positive, invasive breast cancer.

The Oncotype DX breast cancer test is similarly recommended in guidelines issued by the European Society of Medical Oncology in Europe, by St. Gallen, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network in the United States, and by UK's NICE.

NICE, which calculates the cost effectiveness of healthcare interventions and advises whether the UK's National Health System should pay for them, last year officially recommended Oncotype DX breast based on a "revised price" proposed by Genomic Health after the institute initially found that the test's list price did not meet its cost-effectiveness threshold.

NICE suggested in September — when it recommended the use of Oncotype DX breast based on the revised pricing — that Genomic Health collect additional data showing that the test impacts clinical decision making in England and further backed the test's ability to predict chemotherapy benefit.

"In the UK, we continue to work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX breast cancer test and have hired additional medical and commercial staff in preparation of supporting approximately 17,000 patients diagnosed with early­stage, node­negative breast cancer in the UK each year," Cole said. However, he noted that Genomic Health has not yet reached "final administrative arrangements" with NHS regarding this contract.

During the quarter, Genomic Health also established its first agreement with a Swiss payor and the British Columbia Cancer Agency to reimburse the breast cancer diagnostic. In Canada, Oncotype DX breast cancer is available in four other provinces in addition to British Columbia: Ontario, Quebec, Saskatchewan, and Newfoundland.

Genomic Health reported last week that its first quarter revenues were up 6 percent over the first quarter of 2013 driven by its increased test sales. The company brought in total revenues of $67 million for the three months ended March 31, up from $63.1 million in the first quarter of 2013. Genomic Health’s full Q1 earnings and 2014 guidance are detailed here.

In driving adoption of its prostate cancer test, Cole said that Genomic Health will pursue the same successful path it undertook with its breast cancer assay by conducting and publishing numerous studies to establish its clinical validity and utility with payors and doctors. Using this strategy, Genomic Health has secured 90 percent of the breast cancer recurrence testing market with Oncotype DX.

"With 10 completed prostate cancer studies and more on the way … we are executing the same strategy that proved successful in driving widespread use and reimbursement of our breast cancer test here in the US," he said.

Company officials have previously said that the prostate cancer test, which was launched last spring, may represent the biggest market opportunity for Genomic Health to date. Cole estimated during the call that more than 675 physicians have ordered the prostate cancer test and more than half have ordered it for multiple patients.

"We don’t expect broad adoption prior to multiple publications of our clinical impact and decision impact studies," Cole said.

Genomic Health plans to present data on the development and validation of the prostate cancer test at the upcoming American Urologic Association and American Society of Clinical Oncology annual meetings. The company is planning to discuss multiple decision-impact studies at these meetings as well as data from the second validation study involving the test, which addresses its ability to gauge biochemical recurrence risk as an endpoint.

In addition to building the evidence base for the prostate cancer test, Genomic Health is also planning to double its US urology sales staff in the second quarter of this year to 40 reps.

Further, Genomic Health is continuing to build upon the existing evidence base for its breast cancer test and will report a ductal carcinoma in situ study this year. Also, data presented at ASCO at the end of this month will include a comparison of Oncotype DX breast with Nanostring's Prosigna, Steven Shak, Genomic Health’s executive VP of R&D, said during the call.

Shak added that Genomic Health's ongoing research using next-gen sequencing to identify genes associated with prognosis and chemotherapy benefit is progressing. He said the first sample batches in this project have been "successfully analyzed," and the study will finish this year.

The firm also has made progress in the development of its liquid platform. "Data in house and outside have defined the sensitivity required for our liquid platform to give us the ability to deliver the required analytical performance at an acceptable cost for tests that will be performed repeatedly in very large numbers of patients,” Shak said. The first clinical study utilizing the platform is slated to launch this year and will evaluate its ability to reveal important tumor information from blood or urine.

Genomic Health officials also briefly commented on the US Senate's passage of HR 4302, the "Protecting Access to Medicare Act of 2014," which included a section that will establish a market-based payment system for diagnostics under the Clinical Laboratory Fee Schedule.

Cole said the company was "encouraged to see value­based pricing reflected in new legislation passed in March, with a reimbursement methodology designed to align private managed care rates and Medicare rates. …We believe this will provide predictability and transparency to the reimbursement process under the Medicare program for Oncotype DX, as our average private contracted rate is above Medicare's reimbursement rate."

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