to 100,000 women a year, this could turn into an annual market worth $300 million a year, Ding says. “In diagnostics, that’s substantial,” he says.
This model is similar to the one followed by Redwood City, CA-based Genomic Health (NASDAQ: [[ticker:GHDX]]), which has had some success marketing its own genetic test that predicts the likelihood of breast cancer relapse. That assay, called OncoType DX, looks at different gene signatures, Ding says. It’s possible that physicians will want to run that test, as well as the one from bioTheranostics, to gain a more complete picture of a patient’s likelihood of relapse.
Physicians will get a chance to see for themselves this weekend whether they find the data compelling for bioTheranostics. One study of 769 patients with early-stage, post-menopausal breast cancer found that the Theros BCI test was able to predict risk among patients who got tamoxifen treatment without any other preventive, or so-called “adjuvant” therapy. The data was presented at Olle Stal of Linkoping University in Sweden. He noted that while tumor biopsies from these patients looked to be aggressive when examined by a pathologist under a microscope, the bioTheranostics test, looking at a deeper molecular level, classified many of them as “low-risk” and that finding was verified with long-term follow-up.
“The predictive risk of recurrence provided by the THEROS BCI assay provides oncologists and patients with an objective and quantitative tool which helps them make informed decisions about breast cancer treatment,” Stal said in a bioTheranostics statement.
A second study, which bioTheranostics reported in collaboration with Novartis, showed that patients with low expression levels of a gene called HOXB13 had a three-fold greater response rate to letrozole, the Novartis aromatase inhibitor therapy. The study suggests that quantifying expression levels of that gene “could help physicians decide whether additional therapy is warranted in individual patients who have potentially low response rates to aromatase inhibitors.”
But even if the data is as powerful as Ding says, that still doesn’t guarantee the product will be a slam-dunk in the market. Genomic Health has done a lot of health economic analyses to show to insurers, arguing that it’s better to spend $3,000 up front for a genetic test if it can spare a certain percentage of patients from getting rounds of chemotherapy that can cost in excess of $30,000. And the decisions on what to do with the information—should a person with a 4 percent risk of recurrence get preventive chemo?—are still going to make for some complex discussions among doctors and patients.
