This article has been corrected to make clear that Genomic Health expects to make IVD products available in France and Germany in 2020.
NEW YORK (GenomeWeb) – Following a year of major milestones, Genomic Health CEO Kim Popovits said that the company expects to sustain and grow its momentum in 2019 with a focus on increasing adoption of its core breast cancer product in the US, pushing international expansions, and continuing to diversify its test menu.
During her presentation Monday at the JP Morgan Healthcare Conference in San Francisco, Popovits discussed some of the achievements that influenced the company's profitability gains in 2018 and outlined what she said are three "strategic imperatives" Genomic Health will focus on in the coming year — increasing penetration in established markets, broadening global access, and continuing to diversify its portfolio.
Regarding established markets, Popovits reiterated the impact that last year's TAILORx trial publication had on the firm's breast cancer business through the second half of 2018, but also discussed how the results may help expand adoption even further over the next year.
According to Popovits, the study results have allowed Genomic Health to fundamentally change the way it can describe or market the test to potential adopters.
"When I get asked why everybody isn't using [our] test … the number one answer we would get [from doctors] is 'some patients I think I know what to do with them, other patients I get this intermediate score, and I'm not sure how to have that conversation,'" she said. "We knew TAILORx had the potential to answer that question and it definitively did so.
"Now we're in a position … of being able to tell women 'if your risk score is between zero and 26, you will not get benefit from chemotherapy. If it's 26 to 100, you get a substantial benefit,'" she added. "That is big news for the oncology community and especially those physicians that were troubled by this whole intermediate risk score."
Popovits said the company launched a new information campaign at the San Antonino Breast Cancer Conference in December focused on the new, more binary nature of the Oncotype Dx report. That, coupled with an update to the report itself that simplifies recurrence score findings and their meaning has yielded "really positive feedback."
In terms of using this to increase penetration of the breast cancer market, Popovits said that the company plans to specifically target areas of the US where it knows its penetrance is lower than average — places like Florida and Tennessee – with the new campaign.
TAILORx is also expected to help the company achieve its goals internationally, she added. For example, while the UK's NICE initially came out with a disappointing take on Oncotype Dx early last year, post-TAILORx, the advisory body revised its assessment, endorsing the test.
Genomic Health also said that the TAILORx results helped influence a similar about-face by German test evaluators, with the independent scientific institute IQWiG making an "exclusive recommendation" for Oncotype Dx last year after having previously said that evidence was lacking. According to Popovits, this IQWiG endorsement is now being evaluated by the body that will make the ultimate decision whether or not the test will be reimbursed in Germany, with an expected decision in the first half of 2019.
"Following that we are expecting some movement in France with some dossiers that we recently submitted, and Italy to follow," and a final arm of international activity this year will be pursuing a recently identified revenue pathway in Japan, she added.
For these countries, and more importantly other markets like Brazil and China, Popovits said, Genomic Health's work to develop an IVD kit version of the Oncotype Dx breast cancer test will also be a crucial aspect of its international expansion goals.
The firm announced its initial deal with Biocartis to develop a test on the Idylla platform in late 2017. And Popovits said that Genomic Health continues to expect make the product available in France and Germany in 2020.
Genomic Health also said in late 2018 that it was expanding the agreement with Biocartis to include development of kit versions of its Oncotype Dx GPS prostate cancer test. In her remarks today, Popovits said that the company is now preparing for the process of developing the prostate cancer IVD and building up the tools it will need to submit it for approval by the US Food and Drug Administration.
During 2018, Popovits said, Genomic Health was "gating [its] resources" in regard to the non-IVD GPS test, waiting for practice guidelines to be strengthened and for additional payor coverage. Both of those things have now happened, she said, and so the company is going into 2019 with an expanded sales force for the prostate cancer market.
Last year also saw Genomic Health's first partnered product enter the market — an AR-V7 assay developed by Epic Sciences and designed to help guide treatment decisions for men with advanced prostate cancer. The firm received a positive coverage decision from Medicare for the new test last fall, Popovits said, and is planning to use that to push adoption over the next year. "This is a market that's two percent penetrated, so [it's] wide open for us," she said.
Finally, Popovits said, menu expansion will also be an area of focus in 2019, after the firm shed two assay development arms last year, jettisoning both its internally developed NGS liquid biopsy assay and a collaboration with Cleveland Diagnostics it began in late 2017 to advance that firm's IsoPSA test.
According to Popovits, Genomic Health believes its kit development plans with Biocartis will help it achieve its goals to develop or partner on new assays by enhancing its ability to collaborate with pharma or other entities. "You'll see more conversation happening there and more announcements as we go forward in exploring that opportunity," she added.