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Genomic Health Focused on Validating, Driving Adoption of Prostate Cancer, DCIS Tests

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Originally published August 8.

NEW YORK (GenomeWeb) – Genomic Health in the second quarter completed, presented, and published several validation studies supporting the use of its Oncotype DX prostate cancer and ductal carcinoma in situ tests. These two tests are currently the focus of the company's ongoing commercial efforts.

In a conference call recapping the company's Q2 earnings, Genomic Health CEO Kim Popovits said that prostate cancer test volumes grew 54 percent in Q2 compared to the first quarter. Approximately 900 urologists have ordered the test, and "more than half of these physicians have now ordered tests for multiple patients," she said.

The uptake of the 17-gene test, which the company launched in May 2013, was bolstered by the publication of three studies a few months ago in European Urology – two development trials and a third validation study conducted with Cleveland Clinic and the University of California, San Francisco. The development studies enabled Genomic Health to narrow down the panel of genes from 700 candidate markers to 17 genes that address four key biological pathways involved in prostate cancer.

The third clinical validation study involved biopsy samples from 395 men who were candidates for active surveillance. The Oncotype DX prostate cancer test was able to determine which patients were at high risk of prostate cancer and held up as a significant prognostic tool in multivariate analysis against standard clinical measures. Additionally, when the Oncotype DX score was paired with National Comprehensive Cancer Network categories or gold standard CAPRA scores, researchers reported a significant improvement in risk assessments and an increase in the number of patients who would do well with active surveillance.

Building on this data, earlier this week Genomic Health reported positive preliminary results from a second clinical validation study involving the prostate cancer test. Conducted by the Center for Prostate Disease Research (CPDR), the study showed that the test accurately predicted biochemical recurrence – defined as a rise in prostate-specific antigen following surgery. By gauging which patients are at risk for biochemical recurrence, the test can be used to assess longer term patient outcomes.

During the earnings call this week, Steve Shak, executive VP of R&D, elaborated that a subanalysis of 185 patients from one of the original development studies showed that the prostate cancer tests could pick out biochemical recurrence "for all patients regardless of whether they received hormonal therapy, radiation therapy, or no therapy at all" at the time their disease came back.

"For each therapy subgroup, different biological pathways within the test were more highly associated with patient outcome," he said. "These results underscore the importance of incorporating genes from multiple pathways that are highly significant in providing actionable outcomes from the distinct biology patterns within prostate cancer tumors at the time of biopsy."

The company plans to present detailed findings from the CPDR study, including the test's ability to gauge the risk of metastatic prostate cancer and outcomes in African-American patients, at a medical meeting later this year. According to Popovits, the company during the second quarter also completed the first decision impact study involving the prostate cancer test, and is working to publish the findings.

The firm currently employs around a 30-person sales force behind the prostate cancer test. In the coming months, Genomic Health will continue to advance its efforts to drive adoption and reimbursement of this test by investing in other decision impact and observational studies, as well as conducting demonstration projects for payors. "We believe these actions … could lead to meaningful reimbursement in 2015," Popovits said.

Meanwhile, Genomic Health is also looking to expand the Oncotype DX breast cancer test for DCIS patients, a subgroup numbering around 50,000 US women with a pre-invasive form of the disease, which Shak said is often overtreated. In June, the company presented findings from the second validation study in this setting.

The more-than-1,200-patient study, which Genomic Health plans to present at the San Antonio Breast Cancer Symposium later this year, showed that the Oncotype DX DCIS test score could assess the risk of local recurrence – the development of a new invasive breast cancer or recurrence of DCIS in the same breast. According to the firm, this is the largest genomic study conducted in DCIS, and the study found that the test could predict risk of local recurrence in those treated with radiation therapy.

The company also presented data from a decision impact study involving the DCIS test at the American Society Clinical Oncology's annual meeting, which showed that the assay changed physicians' treatment plans for one out of three patients. For 84 patients that doctors initially prescribed radiation before Oncotype DX testing, the same doctors later recommended no radiation for 26 patients after testing. Then, for 31 patients that doctors initially thought didn't need radiation, they changed their recommendation and prescribed radiation for 10 of these patients after viewing their DCIS scores.

Genomic Health is also conducting studies to keep its flagship indication for Oncotype DX in breast cancer up to date with the latest guidelines. In June, ASCO updated guidelines stating that all women diagnosed with hormone receptor-positive breast cancer should have the option of taking hormonal therapy for 10 years, rather than the standard five years.

At ASCO, Genomic Health presented data from a large study that showed that Oncotype DX breast cancer could predict late recurrences in early-stage patients, five to 15 years after receiving initial tamoxifen therapy. This suggests, Shak said, "that the test results may help identify which patients have greater potential to benefit from extended hormonal therapy beyond five years."

Finally, Shak noted that the company is on track to advance a non-invasive liquid biopsy test that will be able to analyze blood or urine samples to measure cancer-related markers or predict response to drugs. During the second quarter Genomic Health started the first clinical study for this platform and has enrolled more than 200 patients into multiple study sites. "Due to the potential to reach across multiple tumor types, we believe our liquid platform could address markets larger than our current breast and prostate cancer opportunities," he said.

As Genomic Health continues to grow its portfolio of products, its expenses will also grow in coming months, company officials said. Although the firm's R&D spending dipped slightly to $13.3 million in the second quarter from $13.8 million in the year-ago quarter, its SG&A expenses jumped 18 percent to $49.6 million from $42.0 million. Net loss during the second quarter was $4.6 million, up from a loss of $3 million for Q2 2013.

Brad Cole, the firm's CFO and COO, noted that the company's net loss in the third quarter will be more than it was in the second quarter due to greater spending on R&D, continued investments in growing adoption of the prostate cancer and DCIS tests, as well as efforts to bolster use of Oncotype DX tests in international markets.

During the second quarter, Genomic Health brought in total revenues of $70.5 million, an 11 percent increase from revenues of $63.7 million in the second quarter of 2013. All the revenues came from product sales.

Genomic Health said that it delivered more than 24,050 Oncotype DX test results in the second quarter, an increase of 17 percent from 20,650 in Q2 2013. International test volumes grew 32 percent year over year, comprising 20 percent of total test volume. According to Cole, the company now boasts 120 million lives covered internationally for the breast cancer test.

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