Clinical Study Supports Adoption of Cxbladder into New Clinical Pathway
The latest published clinical paper for Pacific Edge’s Cxbladder bladder cancer tests reveals the cementing evidence behind the introduction of new guidelines for the assessment of haematuriaby one of New Zealand’s largest public healthcare providers, Canterbury District Health Board (DHB).
The independent, real-world study has highlighted the benefits of using Cxbladder Triage (CxbT) in conjunction with imaging for initial assessment of all patients that present to the clinic with haematuria for investigation for bladder cancer. The results show that this new clinical process would allow approximately one-third of patients to be managed within the community by the primary care provider, avoiding the need for an invasive and expensive cystoscopy.
The majority of haematuria patients treated in secondary care within the New Zealand health system are seen through publicly funded hospitals and out-patient clinics (with access to services tightly managed to capacity using strict criteria and careful review of referrals), supported in the community by a robust and competent primary care sector.
The 13-month study by Canterbury DHB of 571 patients with haematuria, looked to examine the performance of new guidelines, that included CxbT as the only urine test to be used in combination with imaging, to the clinical pathway for investigating haematuria.
In the look-back study, all significant bladder cancers were diagnosed by the new guidelines, combined use of imaging and CxbT, before cystoscopy was undertaken, provided a performance with sensitivity of 97.7% and a negative predictive value (NPV) of 99.8%.
This look-back study concluded that:
- The new proposed clinical pathway has the potential to save considerable amounts of physician and clinical resources without compromising patient safety.
- The high negative predictive value (NPV) of this new clinical pathway would allow approximately one-third of patients with haematuria to be managed without cystoscopy, a net cost saving of approximately 30% of cystoscopies.
- Those patients with a negative CxbT test score could remain in primary care without being referred to secondary care for specialist review thereby freeing up secondary care resources.
- Canterbury DHB estimated that this would free up approximately 200 patient consultations per year and allow management of conditions that might not otherwise reach the thresholds for referral.
- Importantly, patients with haematuria would also safely avoid the social disruption and discomfort of a secondary care clinic visit for cystoscopy.
- The new pathway should be applicable in any health system with effective general practice or primary care and the ability to inform GPs of locally recommended assessment and management of haematuria.
The findings have resulted in the adoption of new local guidelines for all Canterbury DHB haematuria patients, which require that patients who present to their primary care physician in the first instance, receive CxbT and imaging. Patients negative to CxbT and imaging will not now progress to secondary care with its invasive and expensive treatment options.
This new haematuria assessment algorithm was adopted into the Canterbury Community Health Pathways in February 2018 and continuous audit of a further 890 patients has been carried out over the last year to provide a further look-back on utility, performance and patient compliance and safety.
CEO of Pacific Edge, David Darling, said: “The Canterbury DHB look-back study should be essential reading for all large healthcare organisations which are looking to better allocate limited resources and ensure quality patient care. A rapidly growing library of clinical evidence demonstrating the benefits and clinical utility of our Cxbladder tests is being published in respected medical journals, and key opinion leaders are supporting the use of Cxbladder in clinical settings. For a cancer diagnostics company commercialising new medical technology, such as Pacific Edge, the long and arduous pathway to peer reviewed publications provides the lifeblood in achieving clinical acceptance and positive reimbursement outcomes for our products.”