Genomic Health announced this week it is on track for a 2013 launch of its Oncotype Dx test to help doctors distinguish between aggressive and indolent prostate cancer.
According to the company, a large clinical validation trial performed in collaboration with the University of California, San Francisco, has met its primary endpoint demonstrating that the Oncotype DX prostate cancer risk score can discern which early-stage patients are at risk of disease progression. The test analyzes tumor tissue prostate needle biopsies.
Genomic Health said it will report the results from this trial at the American Society of Clinical Oncology's 2013 genitourinary cancers symposium in February.
"Based on these results, Genomic Health is completing the necessary work in its clinical reference laboratory to make the Oncotype DX prostate cancer test available to physicians and patients in the first half of 2013," the company said in a statement.
According to analyst Jon Wood from investment firm Jefferies & Company, the validation trial combined a retrospective and prospective study design. Study investigators analyzed tumor biopsy samples from patients who were being followed for 10 years and were either being actively monitored by their urologists or had gotten a radical prostatectomy.
Genomic Health said it conducted six feasibility and development studies in partnership with the Cleveland Clinic to evaluate more than 700 patients and 700 candidate genes in order to select the multi-gene set for the prostate cancer test. Upon launching the molecular diagnostic, Genomic Health will market it as a tool that doctors can use in conjunction with the Gleason grading system, the prostate specific antigen test, and patients' other clinical data in order to personalize prostate cancer treatment.
"It is widely recognized that a very large percentage of men with low- and intermediate-risk prostate cancer are over-treated due in part to the lack of a standardized, validated biopsy-based test to more accurately distinguish between aggressive and clinically indolent disease," Peter Carroll, the chair of the urology department at UCSF, said in a statement.
Genomic Health estimates that among the 240,000 men diagnosed with prostate cancer in the US each year, the vast majority receive aggressive treatments that cause serious side effects. "Based on the results of this study, we believe the Oncotype DX Genomic Prostate Score will increase the number of patients eligible for active surveillance, and identify those who should consider aggressive treatment," Steve Shak, chief medical officer at Genomic Health, said in a statement.
Genomic Health also markets a 21-gene expression test for breast cancer recurrence and a 12-gene expression assay for colon cancer recurrence. Prostate cancer represents the largest market opportunity the company has pursued with an Oncotype DX test.
Since data from the validation study are still to come, analyst Nicholas Jansen from the investment firm Raymond James said it would be difficult to pinpoint the market opportunity for Genomic Health's prostate cancer test. "Without the full details behind the data, it is difficult to judge the prognostic value of the test and ultimate commercial potential," Jansen wrote in a note to investors. "That said, the decision to pursue commercialization is still a welcome development and gives Genomic Health access to a $1.7 billion market, though the revenue potential is unlikely until 2014 at the earliest."
Meanwhile, Jefferies' Wood projected a $420 million annual market opportunity for Genomic Health's prostate cancer test, given the assumption that the assay is priced at $3,500 (similar to other tests) and that the test will be appropriate for 50 percent of the 240,000 men diagnosed with the disease each year in the US.
Ahead of the prostate cancer test launch, Genomic Health is planning to expand its sales force so a portion of its reps can call on urologists. Given the size of the prostate cancer testing opportunity, "any traction … [is] likely to help offset slower top-line growth in the company's node-negative and node-positive [Oncotype DX] breast cancer franchises," Jansen said.
Meanwhile, Myriad Genetics also markets a prostate cancer test, called Prolaris, for assessing the aggressiveness of the disease for patients before a prostatectomy and to gauge disease recurrence for patients after they've gotten a prostatectomy. Comparatively, Genomic Health is marketing its test for assessing disease aggressiveness for pre-prostatectomy patients.
"Genomic Health notes that the value of such an assay lies at the time of initial biopsy when a decision regarding active surveillance or aggressive treatment (radical prostatectomy / radiation therapy) is to be made," Wood highlighted in his note.