COMPANY:

Pacific Edge

"New data demonstrating the clinical and economic value of Pacific Edge’s Cxbladder cancer diagnostic tests will be in the spotlight at the 100th annual meeting for the Western Section of the American Urological Association (WSAUA) in Kauai, Hawaii."

"Pacific Edge CEO, Dr Peter Meintjes will present the clinical utility evidence from the STRATA study to an APAC audience for the first time. STRATA is the first randomly controlled trial of a urine-based biomarker for hematuria evaluation ever completed. It demonstrated that presenting clinicians with a Cxbladder Triage result led to a 59% reduction in cystoscopies, the primary endpoint of the study."

"Pacific Edge welcomes an editorial in the American Urological Association’s Journal of Urology supporting the use of Cxbladder to reduce unnecessary cystoscopies on patients at risk of bladder cancer."

"Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, has confirmed that it has been granted an extension to finalize or withdraw the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365)...Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting."

"Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, remains in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’...The continued deliberation on the LCD means that Pacific Edge’s tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates and subject to medical necessity guidelines."

"A ground-breaking study demonstrating the clinical utility of Cxbladder is to be the centrepiece of Pacific Edge’s activities at the 2024 American Urological Association (AUA) Annual Meeting to be held May 3 – 6 in San Antonio, Texas."

"Pacific Edge announces the launch of the integration of Cxbladder tests within the Electronic Medical Records (EMR) system of Kaiser Permanente."

"Pacific Edge notes the U.S. Food and Drug Administration (FDA) has released for public comment proposed rule changes that seek to have Laboratory Developed Tests (LDTs) such as Cxbladder regulated as medical devices under the US Federal Food, Drug, and Cosmetic Act...The proposed changes, if finalized, would require Pacific Edge and other LDT providers to present evidence to the FDA that their tests are safe and effective for their intended use in addition to the current regulatory pathway of being accredited through CLIA (Clinical Laboratory Improvement Amendments)."

"Pacific Edge...releases details of written submissions on the draft local coverage determination (LCD) that proposes non-coverage of Cxbladder tests by Medicare, the US national health insurance provider...The written submissions argue Cxbladder Triage, Detect and Monitor tests should retain Medicare coverage based on the clinical value they offer to patients, clinicians, and healthcare payers."

"Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider."

"Pacific Edge notes the release overnight of a new proposed Local Coverage Determination (LCD) governing the reimbursement of its Cxbladder tests by Medicare, the US National Health Insurance provider...The proposed LCD (DL39365), released by the Medicare Administrative Contractor (MAC) Novitas2, notes the Cxbladder tests are ‘not considered medically reasonable and necessary’, the threshold required for coverage under the US Social Security Act."

"Pacific Edge...welcomes a decision from Novitas and First Coast to delay the implementation of the Local Coverage Determination (LCD, L35396) released in early June that would have seen Medicare coverage of Cxbladder cease in the US on 17 July 2023."

"Pacific Edge...announces an update to its billing policies in the US for Cxbladder tests...From 17 July 2023, Pacific Edge will provide for enhanced patient responsibility where a patient’s insurer declines to pay for a Cxbladder test. Pacific Edge will also update its Patient Assistance Program to assist lower income patients with making their bill more affordable."

"Pacific Edge...announces Medicare coverage of Cxbladder tests in the US market is expected to cease from 17 July 2023...This development follows the finalization of a Local Coverage Determination (LCD) (L39365) by Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s laboratory in Hershey Pennsylvania."

"Pacific Edge...announces its key activities at the 2023 AUA Annual meeting to be held April 28 – May 1 in Chicago, Illinois...Pacific Edge will expand its presence at the AUA this year, anchored by a booth in the main hall through which the team will update customers and attendees on the latest product, industry, and clinical program developments."

"Pacific Edge...announces it has completed the software development and integration testing on its project to integrate Cxbladder into the Electronic Medical Records (EMR) system of Kaiser Permanente."

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."