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Genomic Health Anticipates Progress for Prostate Cancer Business, Hints at Other New Tests This Year

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NEW YORK (GenomeWeb) – After announcing positive results for the fourth quarter of 2016, Genomic Health is now anticipating financial progress in 2017, supported by its solid breast cancer testing business, as well as the continued development of the company's newer prostate cancer arm.

Brad Cole, Genomic Health's Chief Operating Officer and CFO, said during a call discussing the firm's earnings yesterday that the firm's revenue guidance for the upcoming year assumes growth in prostate testing, which is expected to be influenced by a shift by Medicare to cover tests for intermediate prostate cancer cases in addition to low-risk cases.

Chief Medical Officer Phil Febbo also shared some updated information about progress both in prostate cancer testing, and for Genomic Health's recently launched liquid biopsy test over the course of 2016. He also hinted at additional new test development for the upcoming year.

Genomic Health got its start in noninvasive breast cancer, and that is still the core of its business. According to Cole, the firm maintains about a 90 percent share of the market, and doesn't expect that to shift significantly in coming years.

This leaves growth in test volume to be driven by the firm's forays into international markets, a continued push into invasive breast cancer in the US — in which CEO, President, and Chairman Kim Popovits said Genomic Health has a market penetration of about 55 percent — and increasingly by the company's budding prostate cancer branch.

Genomic Health competes with Myriad Genetics in the space, and the two have been jockeying for first position in recent months. Last spring Genomic Health appeared to be lagging somewhat behind Myriad based on results from the two firm's quarterly reports.

Based on numbers for the final quarter of 2016, Cole said that Genomic Health now believes that it is the market leader in both low- and intermediate-risk prostate cancer.

During the company's earnings call yesterday, Cole said that Genomic Health achieved "record levels" in its US prostate business in the final quarter of 2016, with a 29 percent increase in test volumes compared to the same period last year. The company made $3.6 million in revenue from prostate cancer tests.

However, some analysts contended that Myriad is still outpacing Genomic Health. Barclay's Jack Meehan, Mitchell Petersen, and Andrew Wald, for example, wrote in a note that they believe Myriad "continues to hold a volume market share advantage over Genomic Health, with superior annual growth rates (on tougher comps)."

Discussing Genomic Health's guidance for the upcoming year, Cole specified that the company's projections hinge not only on overall oncology test growth in the low-to mid-single digits, but also more specifically on growth in prostate cancer above 30 percent.

One hurdle that Genomic Health will need to clear in order to achieve this is that Medicare's current coverage for the test is for only low-risk patients and not intermediate cases.

Myriad received a positive draft decision for its own test for favorable intermediate-risk patients in December. In Genomic Health's call this week, officials reiterated that they expect the same treatment by Palmetto this year, and are "very close" to achieving it.

Last November, Genomic Health said that it had new results from a study that show that its test is the only assay validated to measure all short- and long-term endpoints for men with prostate cancer, including adverse pathology, biochemical recurrence, metastasis, and prostate cancer-specific death.

Company officials said this week that they believe that this data will provide "additional competitive advantage" in increasing adoption and reimbursement for the GPS test.

The firm is presenting details from the study at this week's American Society of Clinical Oncology GU Symposium, as well as at two other upcoming conferences.

Febbo said the company also has presentations at the ASCO meeting illustrating the clinical utility of the test for men who are trying to decide between active surveillance and immediate treatment.

"We expect these data … to support our efforts to gain Medicare coverage for men with intermediate-risk disease and increased coverage by private payors," he said.

Overall, he added, Genomic Health has data from 21 clinical studies in more than 3,600 patients "including prospective data from community-based clinical settings" that reconfirm the independent predictive value of the GPS test.

AR-V7

Last July Genomic Health also made a move to expand its prostate cancer offering, announcing that it had signed an exclusive agreement with Epic Sciences to commercialize Epic's AR-V7 liquid biopsy test in the US, a move that Febbo said underscores the company's commitment to the field of urology.

Epic's test detects the V7 variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells in order to guide treatment decisions for patients with metastatic castration-resistant prostate cancer.

Genomic Health is now planning to launch the test, which it has named Oncotype DX AR-V7 Nucleus Detect, later this year.

"Supported by a recent European Urology publication, we are confident that detection of AR-V7 using the Epic Sciences No Cell Left Behind platform will be the best test in the field," Febbo said during the firm's earnings call.

Results of this study suggest that assessing AR-V7 expression only in the nuclei of circulating tumor cells, as Epic's platform does, may be a better way to predict therapeutic benefit in prostate cancer patients than overall (non-nuclear-specific) measurement of the protein or its associated RNA transcript.

"Given that other available tests cannot distinguish between cytoplasmic and nuclear staining, we are confident that [our assay] will continue to have greater specificity and clinical performance," Febbo said. "Furthermore, we expect this compelling and unique clinical evidence to drive adoption and reimbursement," he added.

Liquid Biopsy

The other major new addition to Genomic Health's roster is also a noninvasive test, a 17-gene liquid biopsy sequencing assay for lung cancer.

According to Febbo, while this test — OncotypeSEQ Liquid Select — is still being used only by a select group of oncology practices, the company has already begun to collect data on its results in clinical use.

Since launching the test last June, 71 percent of the reports the company has issued have identified a variant in one of the 17 genes covered that is associated with some available therapy, Febbo said.

Over 2017, Genomic Health expects to complete accrual of a global concordance study, to publish analytical validation results for the test, and to work toward submission of a dossier to support reimbursement by payors, he added.