NEW YORK – Informed Genomics, a laboratory services spinoff of liquid biopsy firm Nonacus, hopes its market debut through the UK's private healthcare market will give it a foothold for national sales of a bladder cancer test that can stratify patients by cancer risk and help determine who needs follow-up cystoscopy.
The Birmingham, UK-based firm said recently that it forged a deal with the nation's largest private insurer, Bupa, that will give about 8,000 patients per year in the UK access to the Nonacus-developed next-generation sequencing-based Galeas Bladder test and provide an opening into the cancer testing market. Informed Genomics is rolling out the test late this month at private hospitals for patients with Bupa coverage or those who are willing to pay out of pocket.
Nonacus launched Galeas Bladder in March. When a patient presents to a healthcare provider with hematuria, or blood in urine, the test can be used to generate a report used to stratify them into those with suspected cancer and those negative for cancer.
Simon Davis, commercial director for Informed Genomics, said the molecular triage tool can help identify the highest-risk patients that should proceed to flexible cystoscopy and reduce the number of cystoscopy procedures that are performed on people who are at low risk of bladder cancer.
"It covers all hematuria patients, so that's micro- and macroscopic hematuria, which is really important," he said. "And that's where we feel it's novel, that it fits in this triage setting and future use cases could be that surveillance setting as well."
Though the deal with Bupa secures access to only a fraction of the patients in the UK who have hematuria, Davis said that agreement plus further expansion in the private market could give upward of 20,000 patients per year access to the test. The company is also eyeing several pathways to sell the test to healthcare providers within the UK's National Health Service, which would provide access to the test for another 110,000 patients each year.
"Obviously, we're engaging with all of the private sector providers of care, and we are interested in working with the NHS, and we're continuing to develop our data, which would support that national-level reimbursement," he said.
Davis said his company is in conversations with NHS healthcare trusts, hospitals, and academic health science networks that evaluate innovative technologies and pathways to NHS adoption.
For now, Davis expects sales will be about evenly split between insured patients and those who are willing to pay out of pocket for the test at private healthcare facilities. The test costs £399 whether it's covered by Bupa or bought by the patient, he said. Officials from the NHS did not respond to inquiries about the typical cost of a cystoscopy, but Davis said that is about one-fifth the price for cystoscopy in private healthcare facilities.
Early this year, a pair of companies that support technology innovation published a white paper that indicates in part that securing reimbursement for new, complex tests across the UK is an arduous process that requires meeting the evidence requirements of individual hospitals as well as targeting clinicians across the local health trusts that make the decisions whether to adopt new tests. Unlike the treatments defined in the national formulary, the report says, there is no obligation to standardize which tests should be performed across the healthcare system.
In addition, the report authors wrote that the NHS has a fragmented budget that can increase the difficulty of making the case for adoption of a new test because "an increase in cost in one silo is viewed negatively even if it leads to a larger savings in a separate budget."
Davis said he doubts his firm is blazing any new trails by entering the healthcare market through private providers, a move that provides easier access to customers and will help increase familiarity with the test. That usage through private providers will also generate performance and health economic data that Informed Genomics can use to support a submission to the National Institute for Health and Care Excellence, which evaluates medical technologies including in vitro diagnostics.
Nonacus CEO Chris Sale said he would like to see adoption of Galeas Bladder in other countries' public healthcare systems, as well, but disruptive technologies can be slow to gain traction in such systems. Informed Genomics is Nonacus' first customer to bring the Galeas Bladder test to market, although the firm is in the early stages of commercialization through clinical labs and hospitals elsewhere in Europe, where the firm is working with clients to implement the validated test in their facilities. Nonacus has also been in discussions with US-based firms that expressed interest in the test, although he noted that the firm doesn't have a US marketing presence.
Sale said Nonacus spun out its laboratory testing services as Informed Genomics because that business has different skill sets, meets different regulatory requirements, and serves different customers than Nonacus, which is focused on developing low-cost cancer diagnostics tests. The firms operate as independent businesses but are jointly owned by the holding company Advanced Genomics.
Galeas Bladder uses urine samples and next-generation sequencing to analyze 23 genes and identify somatic mutations that are associated with 96 percent of bladder cancers. Davis said studies on three cohorts totaling about 660 patients, 340 of whom had confirmed bladder cancer diagnosis, indicate the test can detect all stages and grades of bladder cancer with 90 percent sensitivity and 85 percent specificity, which he said is comparable to the current standard of care, flexible cystoscopy.
He said about 10 percent of the patients who undergo cystoscopy will receive a diagnosis of bladder cancer, and reducing the number of cystoscopies has the dual benefits of improving access to cystoscopies among the patients who need them the most while reducing the overall testing burden on healthcare providers and patients. He noted the urine sample collection "could be easily done in the comfort of a patient's own home, avoiding that unnecessary time in hospital and, obviously, the uncomfortable test of a flexible cystoscopy."
The company delivers a report on the results to the healthcare provider within two weeks of receiving the sample.
Other firms are vying for a piece of the market for bladder cancer detection and have made some recent moves to bolster their position in that market. AnchorDx, for example, said this month that it inked a long-term deal with DiaCarta that includes commercialization of its DNA methylation-based bladder cancer early detection test, UriFind. KDx said earlier in the month that it signed multiple deals with European distributors for its immunocytochemical URO17 test. Vesica Health is primed to launch its molecular bladder cancer detection test for patients presenting with hematuria, AssureDx, as a laboratory-developed test in the US and potentially seek US Food and Drug Administration clearance of a kit version as well as CE-IVD regulatory clearance for sales in Europe. Predicine also said in 2022 that it secured a CE-IVD mark for its NGS-based blood and urine cfDNA assay.
In addition to the newer entries, the competition includes Abbott's fluorescence in situ hybridization UroVysion assay and Pacific Edge's mRNA-based Cxbladder.
While other molecular tests are available for bladder cancer testing, Davis said they are typically used for post-cystectomy surveillance rather than pre-cystoscopy evaluation and triage.
Nonacus had partnered with the University of Birmingham in the UK to develop the urine-based bladder cancer detection assay using Nonacus' liquid biopsy platform and biomarkers validated through the university's Bladder Cancer Research Centre. Richard Bryan, a University of Birmingham professor and urothelial cancer researcher who led the biomarker discovery studies, said in a statement accompanying the announcement of the Informed Genomics-Bupa deal that his research team at the university's Bladder Cancer Research Centre has continued studies related to Galeas Bladder, now with a focus on designing and delivering clinical studies in multiple bladder cancer settings to support the push for national use of the test.
Bryan was the corresponding author of study results published in February in the journal European Urology Oncology, in which his team tested the accuracy of the biomarkers that would be used in the Galeas Bladder test as well as previous study results published in 2019 in BJU International on the development of the panel of somatic mutations detected in urinary cell pellet DNA and cell-free DNA.
Though Davis said it's too early for him to identify any of the other tests in the company's pipeline, he said the firm is focused on expanding its lineup through whole-genome, whole-exome, and RNA sequencing and designing custom panels especially for oncology and oncology with urology.
Davis said conversations in recent weeks with urologists have further convinced him that hematuria patients with low risk of bladder cancer would benefit from a molecular test that could provide an alternate diagnostic pathway that forgoes the cost and inconvenience of flexible cystoscopy. Engaging further with urologists and hearing their feedback will help the company define how the test could be best used. One urologist told him that 80 percent of his patients have non-visible hematuria with elevated leukocyte concentrations, and upper urinary tract imaging combined with Galeas Bladder could indicate with 90 percent sensitivity whether those low-risk patients have cancer, thereby reducing the number of patients referred for cystoscopy.
Informed Genomics is also conducting a prospective study with about 3,000 patients using the molecular bladder cancer test during the workflow prior to cystoscopy, and the company also wants to conduct studies that could support use of the test for surveillance of patients post-cystectomy, he said.
Although Nonacus is already establishing a customer base of laboratories in Europe, Davis said he sees potential that Informed Genomics could also perform the test for healthcare providers outside the UK by analyzing samples shipped to its Birmingham laboratory, where Informed Genomics provides all its academic research and clinical care services. The lab is accredited according to ISO 15189, which is a quality management standard for medical labs.
Davis said that within the UK, urologists have told him that the volume of patients who are referred for cystoscopy has created a challenge in keeping up with demand. With a tool like Galeas Bladder, they see potential to improve care by removing the lowest-risk patients from that pathway.