of peer-reviewed scientific papers, recommendations on clinical best practices, and seeing other insurers slowly adopt reimbursement before things fell into place. The process to secure strong support for Oncotype Dx took about three to four years, Popovits says.
Even now, the test isn’t quite standard of care. Genomic Health has delivered the test to 160,000 patients in the U.S. with newly diagnosed breast cancer that hasn’t yet spread to the lymph nodes—which is a little more than half of the potential market. So the company is still actively pursuing more of that potential market, while looking to tap into more international markets, and to expand its reach in breast cancer by predicting relapse risk in women with breast cancer that has spread to the lymph nodes.
The company is also putting a huge amount of effort into expanding into tests for other forms of cancer but, as with the breast cancer test, this isn’t something that will happen overnight. Genomic Health, which has grown to 500 employees, has continued to invest big bucks—$35 million last year—in R&D. That’s more than significantly bigger diagnostics companies like Laboratory Corporation of America, Quest Diagnostics, or Myriad Genetics and Laboratories, Popovits says. More than half of that R&D spending went toward developing tests for other cancers besides breast cancer.
The latest thing to emerge from the lab is a new test for colon cancer risk, which was launched in January. The familiar pattern is holding here—Genomic Health needs to produce compelling data in peer-reviewed journals, win support from oncologists, and lay the groundwork one-by-one with insurers to persuade them to pay for it.
“We’ve demonstrated the science works, and the business model works. It took three to four years to get there for breast cancer. It will not that long with colon. We think there will be some leverage,” Popovits says, because payers are now familiar with the Oncotype Dx story, and the company can build on its existing relationships with the same decision-makers.
Still, there is a risk as the system lurches forward
