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Post-TAILORx, Genomic Health Tightens Focus on International Expansion

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NEW YORK (GenomeWeb) – With the long-awaited results from the TAILORx trial now public, Genomic Health is shifting attention and resources back to its core breast cancer test in an attempt to capitalize on a wave of public attention and take advantage of new openings the study has made into international markets.

The company announced that it has dropped the collaboration with Cleveland Diagnostics it began in December to advance that company's IsoPSA test, saying that in the second half of this year it will focus more on finishing its breast cancer IVD development plans, and on educational and marketing outreach in the wake of TAILORx, which was presented at the annual meeting of the American Society for Clinical Oncology in June and simultaneously published in the New England Journal of Medicine.

Discussing Genomic Health's second quarter financial results this week, company officials described the early positive impact from the study results on US sales, evidenced by a 7 percent increase in demand during the month of June — both sequentially and year over year.

Genomic Health CSO and Chief Medical Officer Steve Shak said during the call that the company hosted a "record number of educational sessions" during June and July after the results of TAILORx were released. He also highlighted an editorial published in NEJM last month alongside the print edition of the TAILORx study itself, in which Johns Hopkins University breast cancer co-director Vered Stearns wrote that the results "clearly will aid clinicians in providing treatment recommendations to women with intermediate recurrence scores."

International goals

According to CFO Brad Cole, TAILORx precipitated demand for Oncotype DX even more strongly outside the US, rising 14 percent in June compared with May, and up 10 percent compared with the same month last year.

"Looking ahead, with anticipated reimbursement decisions in the UK and Germany later this year, we expect international revenue to continue to grow in double digits," Cole said during the company's earnings call.

Key to expanding the OncotypeDX breast cancer test internationally are expected decisions by committees in the UK and Germany, both of which Genomic Health said have encouragingly pledged to incorporate the new data from TAILORx into their decision-making regarding coverage for the test.

In parallel with these expectations of new coverage recommendations outside the US, Genomic Health President, CEO and Board Chairman Kim Popovits said that the company expects TAILORx to influence updates to US medical practice guidelines from both ASCO and the National Comprehensive Cancer Network, potentially within the next few months.

Another factor in Genomic Health's prospects for international expansion will be its ability to make good on plans to release an IVD kit version of the Oncotype DX. According to Popovits, with the open questions about intermediate risk scores now closed by the TAILORx data, the company is doubling down on its IVD development work with Biocartis.

"We have reached an important milestone in our IVD collaboration, demonstrating feasibility to perform the Oncotype DX Breast Recurrence Score test on the proprietary Idylla platform [and] are now in the process of building global infrastructure … to increase access in Europe and other markets where localized testing is critical for adoption and reimbursement," she said.

As part of these efforts, Genomic Health is already picking out early access sites to conduct validation studies, as well as "making good progress" with European IVD regulatory requirements, Popovits added.

As this moves forward, the company is on track to launch its Oncotype DX IVD in late 2019, beginning in France and Germany. In addition, based on what Popovits called "rapid progress so far," Genomic Health also now plans to accelerate feasibility studies that would support moving additional tests to the Idylla platform.

Marketing and new research

During the firm's earnings call Popovits said in response to an analyst's question that increased demand following the TAILORx publication can sustain longer, slower growth in its breast cancer business rather than a short-term boost.

"We think the changes in practice guidelines we expect and our ability to educate physicians [about TAILORx] is going to be very important," she said.

The market the company is pivoting to address now is made up not of physicians who use the test already, but those who don't or who have embraced it more hesitantly or intermittently in the past.

Emily Faucette, Genomic Health's vice president of corporate communications, said that post-TAILORx the firm's medical arm has been working more aggressively with key opinion leaders to educate physicians.

The company is also moving into a new phase of direct marketing to patients, using what she called a "deliberate and targeted approach" online.

"We have data on where we are underpenetrated that we can use to focus resources and efforts … [and] we have already have started to see some physicians who had been dabbling in other tests start to use Oncotype more regularly as a result of the [TAILORx] presentation," she added.

Shak added that he believes the company's visibility to an academic audience is going to be bolstered on a longer-term basis, as the TAILORx results are discussed further at upcoming medical conferences and as they begin to prompt new research.

One area of great interest already, Shak said, emerges from the fact that TAILORx made clear that a substantial portion of women with high Oncotype DX recurrence scores still experience late recurrences despite being treated with chemotherapy.

"With a distant recurrence rate at nine years of 13 percent, these patients are still not getting enough benefit … so we are hearing, that there [may now be] studies looking at using recurrence score to identify high-risk patients who might, for example get a CDK4/6 inhibitor, or other similar studies," he added.