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Prostate Cancer MDx Firm GenomeDx to Launch First Test This Year

NEW YORK (GenomeWeb News) – Seeking a share of a market estimated at around $1 billion, GenomeDx plans to launch its first test aimed at prostate cancer during the first half of this year, CEO Doug Dolginow said.

Based on whole-genome analysis to profile RNA expression signatures, the test measures the aggressiveness of prostate cancer in patients who have had a prostatectomy. Typically, after the surgery, a doctor will monitor a patient's prostate-specific antigen levels to evaluate whether the cancer has returned and whether follow-up treatment is needed.

The problem, though, is that even for those post-surgery patients deemed high risk based on PSA levels and pathology, about one-third never develop advanced disease. GenomeDx's test, called Decipher, classifies a patient's risk of disease progression, metastasis, and prostate-related death after a prostatectomy. Based on the results, doctors can then decide on a strategy to manage the disease, Dolginow told GenomeWeb Daily News on the sidelines of the 31st Annual JP Morgan Healthcare Conference in San Francisco last week.

Decipher is currently in field utilization trials at 22 clinical sites across the US, and in preparation of a launch GenomeDx has completed two pre-utilization studies showing the ability of the test to change how physicians manage the disease. During the course of this year, GenomeDx plans to publish those studies, as well as blinded pivotal validation studies showing correct classification of patients post-prostatectomy.

Also ahead of a launch, the Vancouver, British Columbia-based firm is submitting data from its studies to the Centers for Medicare and Medicaid Services in hopes of getting a positive Medicare reimbursement decision. The Medicare population represents about half of Decipher's total target population, "so if we can get those patients covered, it gives us confidence to more widely commercialize it," Dolginow said.

In addition, the company is on target this year for the completion of studies evaluating the predictive ability of Decipher's underlying technology. While Decipher is a prognostic test, the firm is evaluating whether it can also predict which patients are best respondents to hormone or radiation therapy post-surgery.

GenomeDx also is conducting validation studies to determine the use of Decipher to predict whether treatment is needed at all if a patient's PSA level rises after surgery. Additionally, it is developing other tests to address unmet needs in populations distinct from the one that Decipher is aimed at now, Penelope Wood, GenomeDx's director of marketing said, though she declined to elaborate.

The plan is to launch one test each year for the next few years, starting with Decipher, Dolginow said.

In total, the market for the firm's full suite of planned prostate cancer tests is estimated at between $900 million and $1 billion in the US, Dolginow said. While Iris International, now part of Danaher, also offers a prognostic test for prostate cancer called NADiA ProsVue, he said that other tests either already on the market or in development by companies such as Genomic Health, Myriad Genetics, and Hologic's Gen-Probe aren't direct competitors to Decipher because GenomeDx's test focuses specifically on the post-prostatectomy population.

"The issue here is you have to have multiple extensive validation studies around very specific clinical questions, because urologists think almost patient-specifically," Dolginow said. "It's not just that you have prostate cancer, and what're you going to do after cancer. It's [that] you have an intermediate grade cancer and they might look at it differently if it's a Gleason 4+3 versus a 3+4, and [the patient's] a certain age, and the PSA was high before surgery and now it's low. They'll consider that totally differently from a patient who's a Gleason 6 or a Gleason 8.

"So a lot of these companies didn't focus on the specific clinical question," he added. "We have."

Additionally, GenomeDx is conducting validation studies for a test being developed for bladder cancer. Dolginow declined to provide details about the test, saying only that it is directed at helping clinicians diagnose whether a bladder cancer is superficial or invasive.

The Decipher test is based on Affymetrix's whole-genome microarrays and uses formalin-fixed, paraffin embedded surgical resections. It can also use FFPE biopsy samples.

GenomeDx also has an RNA sequencing program in place based on Life Technologies' Ion Proton platform, and while longer term Dolginow sees sequencing as the basis for its test development efforts, for now the technology requires further validation. He added that another three to five years may pass before RNA sequencing can have diagnostic use.

Founded in 2007, GenomeDx completed its Series A financing round a year ago. Dolginow declined to disclose the amount raised but said that it has used the funds to conduct its multiple validation and utilization studies and set up a CLIA laboratory in San Diego. More than 70 percent of its Series A proceeds remain, he added.

"Most of these companies take $65 million or so to build a test," he said. "We're on track to do it for roughly half that amount, so we're a Series A company that has more Series C financing dynamics."

Much of that has been achieved because it is based in Canada, Dolginow said, where GenomeDx has attracted a generous number of government grants to support its development work. Collaborators that he said find the company's work "exciting" have also provided funding.

Its CLIA lab also exists within a facility that was already licensed as a CLIA lab, further providing cost savings. The existing facility had excess space, equipment, personnel, and capacity, and GenomeDx's lab is a shared facility operating under its own standard operating procedures and QA system, Dolginow said.

Though the firm plans to offer laboratory-developed tests, the biomarkers used for them can be translated into in vitro diagnostic formats, and the company has started doing so for possible submissions to the US Food and Drug Administration further down the road, he said.