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Veracyte Aims to Broaden Reach of Decipher Prostate Assay as Studies Continue to Expand Utility


NEW YORK – Cancer diagnostics firm Veracyte noted this week that the Decipher Prostate assays it brought on in its acquisition of Decipher Biosciences earlier this year are continuing to see strong adoption after recent reimbursement milestones, buoying the company in its ongoing research efforts to drive expanded applications for the technology.

During a call with investors discussing the company's Q2 financial results, CEO Marc Stapley said that the Decipher Prostate product line was responsible for more than $18 million in test revenue during the recently ended quarter, a new record for the assays.

The pair of assays, Decipher Prostate Biopsy and Decipher Prostate RP, analyze a targeted panel of gene transcripts to guide treatment decision-making at different time points in disease progression.

According to Veracyte CFO Rebecca Chambers, the company processed approximately 7,000 tests during the second quarter of this year. As the company now pushes forward post-acquisition, it is hoping to drive further adoption both among patients fitting already established indications for the assays and in new niches.

To support these goals, Stapley said the Decipher technology is currently being investigated in seven National Cancer Institute-sponsored Phase III prospective, randomized, controlled clinical trials, as well as 13 additional prospective trials, many of which require testing for study inclusion.

In a new publication this week in Prostate Cancer and Prostatic Diseases, investigators shared real-world data from a retrospective analysis of the MUSIC (Michigan Urological Surgery Improvement Collaborative) registry, supporting Decipher Prostate Biopsy as a tool to guide treatment decisions in patients who are candidates for active surveillance.

According to Veracyte, the data provide the first evidence that Decipher scores predict time-to-definitive treatment and time-to-treatment failure among men with early-stage tumors.

In a statement, Elai Davicioni, Veracyte’s senior VP of scientific and clinical operations for urologic cancers, said that the company believes the new findings fill a critical gap in prostate cancer treatment — "the need for an objective tool that can help physicians identify those early-stage patients who are good candidates for active surveillance, as well as those who should move directly to definitive treatment with surgery or radiotherapy."

Researchers analyzed Decipher risk scores from more than 700 men in the MUSIC registry, calculating the independent association of Decipher high scores with the time to conversion from surveillance to more radical therapy, or from the start of definitive treatment to treatment failure.

According to the authors, among 241 men undergoing surveillance, individuals with high-risk scores spent significantly less time on active surveillance than those with low/intermediate scores (13.6 months versus 33 months, respectively).

Similarly, for the 479 evaluable patients who underwent definitive treatment either initially or after a period of surveillance, those with a Decipher high-risk score progressed to treatment failure much faster.

"We have long needed better risk stratification tools for early-stage prostate cancer patients to reduce the uncertainty that is often part of initial treatment decisions," Randy Vince, a University of Michigan fellow and the paper's lead author, said in a statement. "The findings from our analysis … provide evidence that molecular testing could have significant utility in this setting," he added.

During the call this week, Stapley also highlighted a study published in June in JAMA Oncology, in which investigators retrospectively analyzed data from the Phase III SPARTAN study, showing that Decipher can identify patients with locally advanced prostate cancer who are most likely to benefit from the addition of apalutamide (Janssen Biotech's Erleada), a second generation androgen receptor signaling inhibitor, to antigen deprivation therapy.

"This is … an estimated 165,000 men worldwide for whom physicians have previously lacked genomic biomarkers," Stapley said.

Specifically, the study found that while patients benefited from the addition to apalutamide across the board in SPARTAN, the 116 patients who had Decipher high-risk scores exhibited the greatest improvement in survival.

Discussing the momentum Veracyte has been seeing with Decipher, Stapley said that he believes that the decision to acquire Decipher was made at the perfect time.

"The [insurance] coverage decisions the team was able to get late last year and then the expanded indications, and then the continual publications based on the strong clinical data they've amassed really leads to good momentum in that business that I think helps drive it," he said.

"Clearly Decipher has recovered very well from the early hits from the pandemic," he added, which reflects the fact that a lot of the biopsy-based testing is done through community-based physicians' offices, which have been able to maintain their practices more steadily than hospitals.

"We're getting access to those offices, so that's helping to create a little bit of a tailwind for our business, but other than that, it's just a phenomenal test with good momentum, so I think all of those factors lead into the strong performance that we've seen so far this year," Stapley said.

Decipher is not without competition in the market. Recent guidelines from the National Comprehensive Cancer Network, for example, endorse the use — depending on disease status and stage — of a variety of assays including Decipher, Myriad Genetics' Prolaris, and Exact Sciences/Genomic Health's Oncotype DX Prostate.

Stapley said he believes that Decipher will continue to distinguish itself through the growing bedrock of data that the company and independent researchers have amassed for the assay. "The number of trials that Decipher is in, in addition to the fact that many of those trials actually require the test to be run, really … gets it in the mind share of key opinion leaders and physicians," he said.

In addition to prostate cancer, the Decipher acquisition also brought Veracyte an assay for bladder cancer. Updating investors on that product, Stapley said that the company recently received a final Medicaid coverage determination through the MolDx program.

"In the United States, more than 80,000 individuals are diagnosed with bladder cancer annually, approximately 44,000 of which will have the type of disease indicated in these policies. The test is available to order, and we plan to methodically drive the commercial launch during the third quarter now that Medicare reimbursement is fully in place," he added.