Originally published Jan. 14.
Ten years since Genomic Health commercially launched its flagship Oncotype DX breast cancer recurrence test, the molecular diagnostic firm this week outlined for investors and Wall Street analysts what its business might look like in the next decade.
During a webcasted presentation at the JP Morgan Healthcare Conference in San Francisco, Genomic Health CEO Kim Popovits projected that the company, which currently boasts annual global product revenues of more than $250 million, hopes to be bringing in around $1 billion annually from its new diagnostic offerings by 2020. Additionally, the company is working on developing a non-invasive blood- or urine-based version of the Oncotype DX test, and on advancing new diagnostics that address clinical questions for patients in advanced stages of cancer.
Since 2004, when Genomic Health launched Oncotype DX as a test to gauge breast cancer recurrence for early-stage disease and to predict whether patients will benefit from chemotherapy, the company has expanded the use of the test into six additional indications in breast, colon, and prostate cancers. To date, the company has delivered 400,000 Oncotype DX results to patients in more than 70 countries. The test is covered by most insurers in the US and several other countries and is included in major treatment guidelines for breast cancer.
By 2020, Genomic Health believes that it will have delivered 2 million Oncotype DX results to patients. "We'll be looking at a picture in 2020 that's very different than the picture we see today," Popovits said. "So, looking in 2013, we have a quarter of a billion dollar business … driven mostly by invasive breast cancer. And as we start to expand in ... other areas, we'll see a picture of a more diversified portfolio … leading to $1 billion and upwards in revenue."
At the moment, the biggest market for Oncotype DX remains invasive breast cancer, of which Genomic Health believes it holds around 60 percent. However, there is still room for growth, according to Popovits. "We have regions in the US and we have regions in other countries that have 90 percent penetration," she noted. “So, when you think about having a test that today … [is] recommended in all major cancer guidelines, it's really alarming that two-in-five women are still not getting this test and are making really important treatment decisions, in particular around chemotherapy benefit."
To further drive adoption of Oncotype DX in its mainstay breast cancer market, Genomic Health last year launched a campaign to encourage patients to ask their doctors for the test. Additionally, facing increasing competition in this space from other test providers, Genomic Health has bolstered efforts to spread the message to physicians and patients that Oncotype DX is the only test on the market that is both prognostic for assessing breast cancer recurrence and predictive for gauging chemotherapy benefit.
Meanwhile, the global market opportunity for Oncotype DX when considering all its indications stands at a projected $3.5 billion. But it's still early days for the other Oncotype DX indications, mainly ductal carcinoma in situ, where the company has penetrated 3 percent of the market, and prostate cancer, where 500 physicians have ordered the test and Genomic Health has captured 1 percent of the market.
The firm launched the prostate cancer test last year and has released the first crop of validation data for that indication and for DCIS. According to Popovits, Genomic Health hopes to report results from the second validation studies for Oncotype DX in DCIS and prostate cancer later this year, which should drive further adoption and insurance coverage for the test in these markets.
Genomic Health is also focused on growing the use of its Oncotype DX products in markets outside the US, with a direct presence in Canada, France, Germany, Ireland, Italy, Japan, Switzerland, and the UK. According to Popovits, the international market for its Oncotype DX tests is around $2 billion.
The international market "contributed significantly to our growth in 2013 and we expect for that to hold true in 2014 as well," she said, noting that payors in ex-US markets have covered more than 100 million lives for Oncotype DX tests, mainly in breast cancer. In 2014, Popovits noted that the company will continue to invest in growing Oncotype DX adoption in countries in Western Europe, where there is a more than $400 million market opportunity in invasive breast cancer.
With Oncotype DX, Genomic Health to date has largely focused on curtailing the overtreatment of early-stage cancer patients. Across its various indications in breast, colon, and prostate cancer, Oncotype DX is a diagnostic tool that oncologists can use to determine which early-stage patients are at low risk and can forgo more aggressive treatment strategies.
However, looking ahead, Popovits said the company wants to develop tests that address the needs of cancer patients whose disease has progressed, or recurred. For example, the company is looking at whether Oncotype DX can help doctors decide whether breast cancer patients will benefit from a particular chemotherapy once their disease has recurred or how often a prostate cancer patient should be biopsied following adjuvant treatment. In this regard, the company will look to advance its existing Oncotype DX tests into additional applications, and identify new sets of genes that can address clinical questions in areas of unmet need.
"The issue around the overtreatment of early-stage cancer [is] clearly … a huge opportunity and unmet need, [but] we want to move the business further down … the cancer journey," Popovits said. "There are a lot of patients diagnosed with cancer that are not early stage and they're going to have to make a lot of really important decisions throughout their journey. So, the goal of the company and the research program that we have going forward is to really move down this continuum and focus beyond diagnoses and early-stage treatment and on later stage treatment, recurrence, and response to therapeutics."
Over the past year, Genomic Health has also been working on developing a proprietary liquid platform to enable non-invasive testing based on blood or urine samples. With this test, the company hopes to answer a range of questions around cancer metastasis, disease burden, and response to treatment.
"We'll be reporting more as the year goes on," Popovits said of this early-stage effort. "We've got a study that will be completed in 2014."