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(DL 39365)...Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting."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."