Skip to main content
Premium Trial:

Request an Annual Quote

Ireland's OncoAssure Eyes US Market With 'Master Driver' Prostate Cancer Prognostic Test

Premium

NEW YORK – Irish cancer diagnostics company OncoAssure is launching a lab-developed prostate cancer test in the US this year, with plans to seek regulatory approval for a kitted version in the near future.

The firm's tests center on the idea of identifying subsets of genes whose activity drives cancer progression. These so-called "master drivers" sit at the nexus of numerous biological pathways, where they regulate the expression of downstream prognostic genes, resulting in prognostic signatures indicative of disease progression.

"Most other approaches identify prognostic genes," said Desmond O'Leary, cofounder and CEO of Dublin-based OncoAssure, "but we aim to identify the genes that control those prognostic genes."

Myriad Genetics' Prolaris prostate cancer test, for example, measures the expression of 31 cell cycle genes via quantitative RT-PCR, which is combined with clinical information to produce a combined clinical risk (CCR) score used to estimate the 10-year risk of both metastatic disease and prostate cancer-specific mortality.

O'Leary explained that OncoAssure's approach results in smaller gene panels and correspondingly smaller costs involved in manufacturing and running tests. The firm's flagship OncoAssure Prostate assay, for example, consists of just four prognostic driver genes (FOXM1, MCM3, MTUS1 and TTC21B), and two reference genes (ALAS1, PPP2CA), measured via qPCR. Combined with clinico-pathological information, the assay returns a molecular clinical risk score (MCRS) meant to improve patient risk stratification compared to using only routine clinical information.

OncoAssure recently published a clinical validation study on OncoAssure Prostate, which it plans to launch in the US in the coming months via an exclusive commercialization partnership with Pleasanton, California-based DiaCarta.

That study, published in the British Journal of Urology International Compass, evaluated prostate biopsy tissue from a Swedish cohort of men with prostate cancer, and found that cancer was more likely to occur in individuals with higher OncoAssure Prostate risk scores, whereas those with lower risk scores were marked as candidates for active surveillance. Overall, the study demonstrated that integrating OncoAssure Prostate results with standard clinical and pathological information shows the potential to improve prognostic accuracy.

OncoAssure identifies its driver genes from a variety of in silico datasets, including the Cancer Genome Atlas Prostate Adenocarcinoma (TCGA-PRAD) collection, in the case of its prostate cancer assay. After ensuring that the candidate genes it identifies are involved in key cancer pathways, the company tests these in real-world samples, such as the Urology Prostate Cancer cohort, which the company used in its recent prostate cancer study.

The iterative process of in silico analysis and signature training in human samples, O'Leary explained, enables the company to zero in on what it thinks will be the most prognostic minimal gene combinations.

"We also developed the test in consultation with leading physicians, clinicians involved in treating the disease," O'Leary said, adding that this helps ensure that the company is targeting an unmet clinical need.

In partnership with DiaCarta, OncoAssure plans to launch its prostate assay in the US by the end of the first quarter of this year. The firm has secured reimbursement through the US Centers for Medicare & Medicaid Services (CMS) and has applied for reimbursement approval from Palmetto, under the CMS contractor's MolDx program. O'Leary said that CMS is reimbursing the test at $3,800, "the same reimbursement rate as the existing tests on the market."

While O'Leary couldn't discuss the financial details of the agreement with DiaCarta, he said that it goes beyond a simple licensing agreement. "It is very much a collaboration," he said.

O'Leary said that launching OncoAssure Prostate as an LDT is the fastest way to enter the US market but noted that the company does plan to develop it further.

"We intend to follow that up with a kit-based version of the test where we will go down the FDA approval route," he said.

OncoAssure is focusing on the US market first, O'Leary said, because of its size.

"It's the biggest market by a mile," he said. Nonetheless, he commented that the firm plans to also seek IVDR certification in Europe in the near future.

Although OncoAssure will be jumping into an active field with its prostate cancer assay launch, O'Leary sees plenty of opportunity for growth, saying that he estimates the US market to be only 25 to 30 percent penetrated.

"We think there's plenty of room for a new test that has some added features and [is] a high-performing new test," he said.

Other test developers tend to agree and are busily working to expand their own activities here over the course of the year.

George Daneker, president and chief clinical officer for Myriad, said via email that that company plans to expand agreements with leading solution providers in digital pathology and electronic medical records this year to streamline the workflow processes for its Prolaris test.

"In addition," Daneker wrote, "we are making significant investments in both healthcare provider and patient education to ensure that the clinical validity and utility of Prolaris is widely understood and utilized."

Although Prolaris has already undergone extensive validation studies and is included in National Comprehensive Cancer Network guidelines, Daneker commented that Myriad nonetheless has several studies underway focusing on the test's clinical utility.

"Specifically, our studies are evaluating how Prolaris can help identify the right patients for active surveillance based on the active surveillance threshold and reinforce the safety of Prolaris' active surveillance recommendations," Daneker said.

Another competitor, Irvine, California-based MDxHealth, which acquired the Oncotype DX Genomic Prostate Score assay from Exact Sciences, recently estimated 50 percent year-over-year growth in tissue-based test volumes for the fourth quarter of last year, and 31 percent year-over-year growth for the full year.

"We've seen an acceleration of our tissue-based [test] growth, but there's still market opportunity there," MDxHealth CEO Michael McGarrity said.

OncoAssure works closely with University College Dublin, from which the company spun out in 2021. The roughly 10-employee company is based on the UCD campus, where it primarily focuses on developing products based on research conducted at the university.

O'Leary said that the firm is just beginning to build its own sales and marketing team and plans to hold a fundraising round later this year, which will enable it to complete the launch of the prostate test and the development of a planned melanoma test.

"That could potentially bring us to profitability," O'Leary said.