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Genomic Health Awaiting Prostate Test Reimbursement; Shifting R&D Toward Liquid Biopsy


NEW YORK (GenomeWeb) – Genomic Health has seen continued growth in the adoption of its Oncotype DX prostate cancer test, and is in the midst of publishing two clinical utility studies that it hopes will add to the evidence it has collected to support Medicare reimbursement, a final hurdle toward broader commercialization.

Meanwhile, the company said this week that it is shifting some resources away from its Oncotype DX stalwarts to a new field of testing — liquid biopsy — where it joins a growing group of companies seeking to commercialize tests that detect cancer-associated DNA alterations in patient blood or other body fluids.

Genomic Health executives discussed these and other initiatives during a call this week recapping the company's first-quarter earnings.

On the prostate cancer front, Genomic Health said that it delivered triple the number of prostate tests during the quarter ended March 31 compared to the same period last year.

Genomic Health CFO and COO Brad Cole said during the call that usage data suggest that the test is providing "real-world value to physicians." Specifically, "repeat orders were up 22 percent and physicians who have ordered 10 or more tests increased by 37. To date, more than 1,800 physicians have used the prostate test in their treatment decision planning," he said.

Last month, Genomic Health published the first of two decision impact studies on its prostate cancer test in the journal Urology Practice showing use of the test substantially increased the number of men deemed eligible for active surveillance rather than immediate treatment.

In 158 newly diagnosed prostate cancer patients, researchers found that incorporation of Oncotype DX prostate results changed treatment recommendations — either their modality or intensity — in 26 percent of patients across multiple urology practice settings.

Additionally, 85 percent of urologists were more confident in their treatment recommendation after considering the Oncotype DX test results.

Results of a second similar decision impact study have also been accepted for future publication in the same journal, Genomic Health CSO Steve Shak said. In addition, company researchers will also present four studies on the clinical utility and health economic value of Oncotype DX for prostate cancer later this month at the annual meeting of the American Urological Association.

Still, a dramatic growth in adoption of the test will require Medicare reimbursement, company officials stressed. During the call, Cole called Medicare reimbursement for Oncotype DX prostate a "critical near-term" step, and said it will be essential to the company's ability to deliver a profit in the fourth quarter of 2015.

While the company did secure a recent purchase agreement with US government facilities for the Oncotype DX prostate cancer test and said it is continuing ongoing coverage discussions with leading private payers, it has yet to secure Medicare reimbursement.

Genomic Health President and CEO Kim Popovits said that the firm currently has about 30 sales reps in the field focused on advancing adoption of the assay.

"As large as this market is, clearly 30 is not the sales force that we intend to land on. But similar to what we did in breast cancer, we don't want to get too far out ahead of ourselves here in front of reimbursement. So reimbursement is the next milestone where we would make the decision to increase the size of the sales force," she said.

Liquid biopsy

Beyond advancing its prostate cancer assay and maintaining its established breast cancer business, Genomic Health is also working toward commercialization of its first non-invasive liquid biopsy assay in 2016.

During the call, Cole mentioned that Genomic Health wound down a breast cancer collaboration and license agreement during the quarter, resulting in a one-time, $5.5 million R&D expenditure. This wind-down is expected to enable the company to shift resources toward other pipeline programs, primarily liquid biopsy, he said.

Popovits added that the company made significant clinical progress towards advancing its liquid biopsy platform during the quarter and will share results from a study of bladder cancer testing from urine samples at the AUA meeting.

Though Genomic Health has mentioned its plans to develop liquid biopsy tests for breast and bladder cancer, it has not disclosed much detail about the intended use for the tests — whether in cancer diagnosis, prognosis, treatment monitoring, or even early detection.

In an interview with GenomeWeb, Shak clarified that though the company has not solidified the disease area and details for the first test it plans to release in 2016, its initial focus is on the detection of cancer recurrence and the development of drug resistance.

"Just saying that you have markers or have data doesn't translate into incorporation into clinical practice," Shak said.

"When we started out with Oncotype there were lots of microarray experiments. What we set out to do was to define specific purposes for which a test might be used with a focus on the patient and their needs," he explained.  "Now with liquid biopsy … as we look at it, there is a need in different tumor types either to identify a recurrence sooner in order to treat it earlier, or to identify resistance so patients can get to the right drug as opposed to staying on an ineffective drug."

During the annual meeting of the American Association for Cancer Research last month, multiple presentations highlighted the ability of liquid biopsy to detect subclonal mutations associated with acquired therapy resistance that can be missed in tumor tissue.

Shak did not detail any specific resistance mutations or associated drugs that Genomic Health is researching.

Previously, company scientists have shared data comparing the company's NGS- and PCR-based technologies to detect tumor DNA in urine and blood across various stages of breast and bladder cancers. In this research, they also evaluated DNA copy number aberrations, methylation, and single nucleotide variations to identify which might be the most accurate marker to target.

Besides its forthcoming AUA meeting presentations, Genomic Health will also present a proof-of-concept liquid biopsy study in bladder cancer at the AACR Precision Medicine meeting in June, Shak said.

He added that Genomic Health is also excited about the possibility of collaboration with others to accelerate the development of new therapies or drug combinations.