COMPANY:

Pacific Edge

P=NA | N=92| "Cancer diagnostics company Pacific Edge...today welcomes the release of new research supporting the clinical utility of the company’s genomic biomarker test Cxbladder Monitor in the surveillance for bladder cancer recurrence....Of the sample, 66 patients tested negative for Cxbladder Monitor. Of those, 52 patients underwent a follow up cystoscopy, and all were tumor free – a result that supports the growing portfolio of evidence that Cxbladder Monitor can safely reduce surveillance cystoscopies without compromising cancer detection. Meanwhile, a patient satisfaction survey of those who took the Cxbladder Monitor test at UCSF revealed strong patient acceptance for the test and the PIHSS."

"Pacific Edge...announces its key activities and highlights at the 87th Annual AUA Southeastern Section (SESAUA) meeting to be held March 15-18 in Amelia Island, Florida...Alongside the Symposium, Pacific Edge will lead a Principle Investigator Meeting for the DRIVE study – a study focused on Cxbladder validation in a veterans cohort across multiple VA sites for which it plans to conclude enrolment in 2023."

"Pacific Edge...announces the acceptance for publication of new clinical evidence that shows significant improvements in the performance of its genomic diagnostic Cxbladder tests. These performance improvements were achieved by the addition of DNA biomarkers to Cxbladder Triage (CxbT) and Cxbladder Detect (CxbD), Pacific Edge’s products for hematuria evaluation."

"Pacific Edge today provides further information for shareholders on proposed changes to the Medicare Local Coverage Determination (LCD) that governs the reimbursement of Cxbladder in the US...The proposed changes to the LCD by Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s US laboratory, have the potential to disrupt the reimbursement of Cxbladder."

"Pacific Edge today announces it has substantially completed a commercial agreement with the Southern District Health Region (SDHR) for the use of its non-invasive Cxbladder genomic biomarker tests...The SDHR, which under the new Te Whatu Ora, Health New Zealand, has assumed administrative healthcare responsibility for 326,000 people across Otago and Southland, will deploy Cxbladder Triage into the primary care setting."

"Pacific Edge today announces it has reached more than 50% enrolment in its study to demonstrate the clinical utility of its advanced genomic biomarker Cxbladder tests in safely stratifying low-risk patients presenting with blood in urine (hematuria)...The Safe Testing of Risk for Asymptomatic Microhematuria (STRATA) study aims to further demonstrate how Cxbladder can safely risk stratify patients presenting with hematuria into those that may receive a less-intense evaluation for the presence of bladder cancer and those that should continue with a standard evaluation."

"Pacific Edge...pleased to report strong interest in its advanced genomic biomarker Cxbladder tests from the recently-concluded American Urological Association (AUA) Annual Meeting in New Orleans...The performance characteristics established in Pacific Edge’s catalogue of peer-reviewed publications and, the more than 500 monthly users of Cxbladder products and the exciting clinical utility studies roadmap have spurred significant optimism that Cxbladder can address a number of unmet needs in the urological care pathway."

"Pacific Edge...announces it is advancing its clinical evidence generation program with LOBSTER – a clinical study focused on demonstrating the clinical utility of Cxbladder Monitor for surveillance of recurrent urothelial cancer against the current American Urological Association (AUA) standard of care targeting existing guidelines language for greater inclusion of Cxbladder...Pacific Edge has contracted two sites, has initiated one site to date, and expects to enrol the first patient in LOBSTER this quarter."

"Pacific Edge...announced that it has reached its first commercial agreement of scale in Australia with Northern Health, a major provider of healthcare and hospital services to Melbourne’s rapidly growing outer northern suburbs...Initially, urologists at Northern Health will use Cxbladder Monitor to help manage patients undergoing surveillance following treatment of their bladder cancer."

"Late last week, at the Annual Meeting of the Society of Urologic Oncology (SUO) in Orlando USA, urologists at UCSF presented their findings on the use of Cxbladder Monitor (CxbM) in a real-world setting for managing patients during COVID-19...The findings provide strong validation for Cxbladder’s use when cancer patients might either be unable to come to a clinic in a risky pandemic setting, or when they live in a rural location or an area distanced from a clinic. This real-world clinical evidence highlights the positive outcomes for both the clinic and patient alike, providing further support for guidelines inclusion."

"Pacific Edge is pleased to announce that the American Urological Association’s (AUA) Journal of Urology has published a real world lookback highlighting the clinical utility of Cxbladder in a Covid-19 setting for the management of patients outside the clinic. The lookback study concluded that the use of Cxbladder Monitor and Pacific Edge’s Patient-In-Home Sampling System by physicians reduced the number of cystoscopies required, and that it was both feasible and safe for patients being monitored for urothelial cancer during the Covid-19 pandemic."

"Pacific Edge is pleased to confirm that the company has reached commercial agreement with Taranaki District Health Board (DHB) for the use of Cxbladder products across the clinical pathway in the detection, management, and monitoring of bladder cancer patients. This further extends Cxbladder's national coverage delivered through New Zealand’s public healthcare providers...Under the agreement, Taranaki DHB will provide access to Cxbladder Triage, Detect, Resolve and Monitor tests for patients throughout the region, with Cxbladder urine sampling systems sent to Taranaki Pathology collection locations to facilitate ease of access and specimen collection."

"Pacific Edge Limited is pleased to advise that it has reached a commercial agreement with Northland District Health Board (DHB) and Northland’s primary health entity Mahitahi Hauora for the use of Cxbladder products. This will extend the national coverage of Cxbladder delivered through New Zealand’s public healthcare providers...This agreement highlights Cxbladder’s reach in New Zealand and draws attention to the utility of the Cxbladder for Maori and for those in more remote parts of New Zealand. Instead of travelling all the way to Whangarei to the hospital or waiting for a regional urology clinic to be scheduled, patients in the Far-North can get the Cxbladder test locally under the care of their GP thereby enabling local physicians to make timely referral decisions."

"Pacific Edge is pleased to advise that a new scientific and clinical paper validating the diagnostic performance of its fourth Cxbladder test, Cxbladder Resolve (CxbR), has been accepted for publication in the Journal of Urology. The Journal of Urology is the official Journal of the AUA and the most widely read and highly cited journal in the field of Urology."

"Pacific Edge Limited is pleased to advise that its Cxbladder bladder cancer diagnostic tests are now covered by United Healthcare, the largest healthcare group in the US. Effective from 1 April 2021, Cxbladder is now being covered as a ‘medically necessary bladder tumor marker test’, under United Healthcare’s Molecular Pathology/Molecular Diagnostics/Genetic Testing (Medicare Advantage) - Medical Policy."

"Pacific Edge Limited has concluded a commercial agreement with Facey Medical Group, a physician owned medical group in California. The agreement covers the use of Cxbladder Detect and Cxbladder Monitor for Facey Medical Group patients."

"Bladder cancer diagnostics provider, Pacific Edge Diagnostics, has been notified by Novitas1 that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder (0012M and 0013M) for tests performed on or after July 1, 2020 that are medically necessary. This LCD coverage enables national reimbursement for Cxbladder tests performed among the approximately 62 million people who have Medicare coverage with the Centers for Medicare and Medicaid Services (CMS) across the USA."