Pacific Edge Ltd (ASX: PEB) shares are catching the eye of investors on Friday.
In morning trade, the ASX small cap stock was up as much as 145% to 13.5 cents.
The cancer diagnostics company's shares have pulled back since then but remain up 100% at the time of writing.
Why is the ASX small cap stock rocketing?
Investors have been the buying the company's shares after the American Urological Association (AUA) included its Cxbladder Triage product as the standard of care for the management of patients presenting with microhematuria.
The release notes that the Panel has incorporated language for the use of urine-based biomarkers for intermediate-risk patients. It specifically mentions Cxbladder Triage as the only urine-based biomarker test that has Grade A evidence from a randomised controlled trial in support of this recommendation.
As a consequence of the new guideline, the ASX small cap stock anticipates an uplift in demand for Cxbladder tests as more clinicians in the United States and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria.
Pacific Edge also expects to leverage the guideline language in its ongoing policy dialogue with Medicare Administrative Contractor (MAC) Novitas and the Centers for Medicare and Medicaid services.
It points out that under current legislation, MACs are required to consider consensus statements and guidelines in determining coverage. Pacific Edge will inform Novitas of the new guideline and expects to use the AUA guideline and the evidence on which it is based for a formal reconsideration of a local coverage determination (LCD).
'A significant milestone'
The ASX small cap stock's chief medical officer, Dr Tamer Aboushwareb, appeared to be delighted with the news. Dr Aboushwareb said:
The inclusion of Cxbladder Triage in the AUA guideline for the management of microhematuria is a significant milestone for Pacific Edge. While the guideline does not mandate the use of Cxbladder Triage, they are authoritative, reinforcing best practice within the urological industry and supporting greater adoption of Cxbladder in hematuria evaluation.
Cxbladder is the only test supported by a Grade A evidence from the AUA Guideline panel and the update reflects the strength of the evidence supporting Triage and will help to reduce the burden of unnecessary cystoscopies in patients of lower risk, resulting in less patient discomfort and less morbidity, and improved access to care by reducing wait times.
