NEW YORK – Bladder cancer diagnostic firm Pacific Edge is hoping that an increased focus on generating clinical utility data will be a catalyst in boosting adoption of its assays in a market that it has so far only partially penetrated.
Though headquartered in New Zealand, the company's business has evolved in recent years to focus almost entirely on the US market, which generates 95 percent of its revenue via a suite of tests for patient triage, prognostication, and monitoring.
Pacific Edge reported earlier this month that its fiscal fourth quarter test volumes were up 42 percent year over year, with 8,878 tests processed overall, 7,817 of which were run for US customers in its Hershey, Pennsylvania, facility.
CEO Peter Meintjes said that the adoption of the company's tests really began to ramp up beginning in 2017, but the last three years have been a notable inflection point.
According to Meintjes, although the firm received a positive local coverage determination from Medicare Administrative Contractor Novitas in 2020 for its Cxbladder Triage assay — a test to identify low-risk patients for whom physicians can safely de-intensify hematuria evaluation — it's not clear that coverage itself has driven the firm's recent growth. However, it has allowed the company to begin ramping up its efforts to build utility data and market its assays in the clinic, he said.
"Knowing that we've got a solid revenue stream means that we can put more people in market, so we've grown our commercial presence substantially," Meintjes said. "The whole US operation is around 65 people right now and … I think it's grown by about 20 people over the last 12 months in the US alone."
The company has a testing contract with Kaiser Permanente and is currently in the process of integrating with the health system's electronic medical records, one of the first diagnostic firms to go through this process.
But there is still a large swath of urologists and uro-oncologists that the company has not yet reached.
Pacific Edge's tests fit into a specific area of the bladder cancer treatment continuum — the assessment of patients with non-muscle invasive bladder cancer and patients presenting with hematuria, or blood in the urine.
Mapping the market size, Meintjes said the number of bladder cancer diagnoses is about 81,000, of which most of those, about 60,000, will be non-muscle invasive and 20,000 or so will be muscle invasive.
For those non-muscle invasive tumors, the company has shown that its urine-based gene-expression assay can help doctors assess whether patients are likely to have aggressive or more invasive cancers and accelerate or intensify treatment accordingly. The firm calls this testing Cxbladder Resolve.
Treatment in this setting usually doesn't involve cystectomy, or removal of the bladder. Patients' tumors are resected as much as possible through the urethra and are then monitored for recurrence, traditionally with cystoscopy. Pacific Edge is also targeting this setting with a version of its assay called Cxbladder Monitor.
Meintjes said the firm's LOBSTER (Longitudinal Bladder Cancer Study for Tumor Recurrence) clinical trial will hopefully help it integrate into that care pathway by cementing evidence for the test's utility as a noninvasive adjunct or alternative.
"Even the most ardent supporters of cystoscopy, they know that there are patients who are getting unnecessary cystoscopy in the surveillance setting, so there's a high level of interest in dropping cystoscopy there," Meintjes said.
Meanwhile, in the triage setting, Cxbladder can be performed in hematuria-presenting patients to assess risk of cancer itself, potentially saving those who are unlikely to have cancer from invasive and costly follow-up.
"On the diagnosis side there's less interest in dropping cystoscopy. But in the asymptomatic phase … there's potentially high interest," Meintjes said.
Recently published data on this application has included a study in which the company was able to significantly boost the sensitivity of Cxbladder Triage by adding DNA biomarkers — SNPs in two genes measured in the urine via droplet digital PCR.
"It looks like we can safely rule out 83 percent of patients when they present with hematuria," Meintjes said.
But stronger clinical utility data will be necessary for guideline inclusion in the triage setting.
"Short and medium term, this is what we're focused on because this is what ultimately gets us paid in the US," Meintjes said. "We are covered today, but to ultimately get guidelines inclusion, private payor coverage, and all those kinds of things, we have to be focusing on what the requirements are for guidelines, not just for coverage under the 21st Century Cures Act. When I inherited the company, there was some focus there, but it is more of a priority now."
In that vein, the company is currently running a trial called STRATA, which aims to recruit 600 patients, randomizing them to Cxbladder-informed follow-up or standard of care.
"We believe our triage product will demonstrate the kind of clinical utility that should get a guidelines mention," Meintjes said.
The STRATA cohort should be complete in Q2 of this year, he added, noting that the company is hoping for a readout in June but that it's more likely to come in September. "Then we've got to publish within … three to six months from there, and then we will be able to take it to the National Comprehensive Cancer Network," he said.
One stumbling block in the immediate future is the fact that Novitas proposed a draft local coverage determination last year that would see Pacific Edge lose its current Medicare coverage.
"We've commented on that, and we think they made a few mistakes," Meintjes said, noting that the main thrust of the proposed LCD was driven by the payors' need to tamp down on pharmacogenomics tests, and Pacific Edge believes it got "caught up as a consequence of that."
"We think they'll come to a sensible conclusion," he said. "The best thing that we can do [in the meantime] is continue to generate evidence that would get us a reconsideration."
Longer term, the company does hope to expand research into additional applications. In 2017, the company had mentioned intentions in colorectal cancer and melanoma. But Meintjes said that his tenure at the company has really been a time of refocusing on bladder cancer and making it a "success story," for the company.
Looking to the future, there are expansion opportunities even without having to move into other cancer types, he added, such as screening or minimal residual disease monitoring post-cystectomy.
"Prostate would be a lovely adjacent place to go into, but it's highly congested and almost certainly wouldn't make good commercial sense even if we had the best product by a country mile. We'd be quite late to the game," he added.
For establishing a screening use case, Meintjes said that Kaiser Permanente, already a partner in terms of contract testing, would be an ideal system to work with on the necessary research.
He called the current relationship "pretty commercial and arm's length," so the company wouldn't be able to just dictate a research program, but he said that Pacific Edge knows thought leaders in the system who have already brought up this area as an unmet need.