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Genomic Health Confident in Gaining Ground in Prostate Cancer Testing as It Preps Liquid Biopsy

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NEW YORK (GenomeWeb) – Genomic Health officials this week discussed the firm's efforts aimed at gaining reimbursement for its Oncotype DX prostate cancer test and discussed plans for its highly anticipated liquid biopsy offering, which is expected to launch later this year.

Despite high hopes for growth in the prostate cancer testing space, Genomic Health appears to be lagging somewhat behind its major competitor and current market leader in this new prostate cancer prognostic space, Myriad Genetics, based on results from the recently ended quarter.

Myriad said this week that during it fiscal third quarter — which corresponds to the calendar first quarter of 2016 — sales from its Prolaris test grew 940 percent, bringing in $5.2 million.

In contrast, Genomic Health made only $2.6 million in prostate test revenue during the quarter.

Genomic Health executives have stressed previously that Medicare reimbursement would be a major driver for the firm in advancing Oncotype DX prostate and reaching overall profitability in their business. However, although the prostate test has been reimbursed by the Centers for Medicare and Medicaid Services since last October, Genomic Health executives said during the call this week that they are not collecting as much revenue from CMS-covered testing as they could be, and they expect to further ramp up reimbursement and thus revenues in this area.

Speaking on a conference call following the release of its quarterly financial results, CFO and COO Bradley Cole said that of the company's $2.6 million in prostate test revenue during the first quarter of 2016, approximately $1 million was from CMS reimbursement.

However, he stressed that this represented only about half of the total eligible Medicare revenue, implying that as Genomic Health gets better at efficiently collecting required billing data and working with the payor, the company should see its prostate test revenues go up in subsequent quarters.

Genomic Health Chairman, CEO, and President Kim Popovits also said that the firm's practice of reporting tests delivered rather than tests ordered may also undersell its progress in growing its prostate cancer testing business compared to competitors.

All in all, she argued, though the company may not be leading the market now, it is looking forward to accelerating growth throughout this year. "We've got an additional number of sales reps now in place, and having worked through some of the administrative issues, we think we're in great shape," she said during the call.

According to Cole, more than 2,900 physicians have ordered an Oncotype DX prostate test so far, and repeat orders during the first quarter of 2016 grew 33 percent sequentially compared to the fourth quarter of 2015.

Phil Febbo, Genomic Health's chief medical officer, also provided an update on the company's research activities in the prostate cancer space. According to Febbo, Genomic Health has completed over 20 prostate cancer clinical validity and utility studies that together include more than 3,500 patients.

He also said that the company has presented, or will present, data on Oncotype DX prostate at several major urological meetings this year. Looking ahead, the company has ongoing studies that it expects to complete soon.

Liquid biopsy on the way

Meanwhile, Genomic Health is also gearing up for the launch of a completely new test for a separate and novel market, its Oncotype SEQ liquid biopsy assay.

Febbo said during the call that Genomic Health is currently completing analytic validation of Oncotype SEQ, its first blood-based product, and remains on track to launch the test mid-year.

"We're locking down our analytical validation, so that we know when we report out a result, what the significance of that is for the patient and the provider," Cole said.

Oncotype SEQ will be a next-gen sequencing-based test focused on actionable genomic alterations in a select number of genes intended to help personalize treatment of patients with late-stage solid tumor cancers including lung, breast, colon, melanoma, ovarian, and gastrointestinal stromal tumors.

Genomic Health will be one of many new entrants into a nascent liquid biopsy market, and it will not be the only targeted NGS-based player.

According to Popovits, Genomic Health hopes to distinguish itself by offering a product that is decidedly more focused, and more narrow in its scope than larger panels that are already being marketed by other companies such as Guardant Health.

 "We are looking at a very targeted panel, one that focuses on [National Comprehensive Cancer Network] level-one evidence or targets that are associated with FDA approved drugs … or where it would allow patients to be eligible for [available] clinical trials," Popovits said.

"We [want] to provide [this more for] the community oncologists versus the academic centers or in the research world, with the tool that is actionable today and that can give them immediate information on where to guide a patient."

This tight focus is also something the company believes payors will be more inclined to reimburse for than broader tests, Popovits said.

However, Genomic Health isn't the only firm to say it thinks a focus on only the most actionable alterations is the way to go in liquid biopsy. Resolution Biosciences has made that a hallmark of it's own plans. And other companies like Trovagene and Biocept are working on developing narrow liquid biopsy test menus as well.

Upon completion of its analytic validation study some time mid-year, Genomic Health plans to make Oncotype SEQ commercially available through it's CLIA lab. The firm will then focus on completing concordance studies comparing results of the liquid biopsy test with tumor tissue sequencing, Cole said.

According to Popovits, once the company has launched Oncotype SEQ, it also plans to begin validation work on a second liquid biopsy test, though she did not provide further details on this planned second assay.

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