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COMPANY:
Pacific Edge

i
Other names: Pacific Edge Limited | Pacific Edge Ltd
Related tests:
Evidence

News

5ms
Kaiser Permanente EMR integration goes live (Pacific Edge Press Release)
"Pacific Edge announces the launch of the integration of Cxbladder tests within the Electronic Medical Records (EMR) system of Kaiser Permanente."
Launch
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Cxbladder
6ms
FDA signals intent to regulate lab developed tests (Pacific Edge Press Release)
"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)."
Regulatory
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Cxbladder
7ms
Pacific Edge releases submissions on Medicare LCD (Pacific Edge Press Release)
"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."
Medicare • Reimbursement
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Cxbladder
8ms
US urological societies call for Medicare LCD revision (Pacific Edge Press Release)
"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."
Medicare • Reimbursement
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Cxbladder
9ms
Novitas releases new draft LCD (Pacific Edge Press Release)
"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."
Reimbursement
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Cxbladder
9ms
Pacific Edge welcomes stay of Novitas LCD (Pacific Edge Press Release)
"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."
Medicare • Reimbursement
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Cxbladder
10ms
Pacific Edge updates billing policies for US testing (Pacific Edge Press Release)
"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."
Reimbursement • Clinical
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Cxbladder
11ms
Medicare coverage of Cxbladder expected to cease (Pacific Edge Press Release)
"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."
Medicare • Reimbursement
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Cxbladder
12ms
Pacific Edge announces key activities at AUA 2023 (Pacific Edge Press Release)
"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."
Clinical
1year
Pacific Edge provides update on Kaiser EMR integration (Pacific Edge Press Release)
"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."
Clinical data
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Cxbladder
1year
Study Adds Support for Cxbladder Monitor Use in Cancer Surveillance (Cision)
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."
Clinical data
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Cxbladder
1year
Pacific Edge to showcase leading biomarker strategies for the evaluation and management of bladder cancer at SESAUA (Pacific Edge Press Release)
"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."
Enrollment status
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Cxbladder
over1year
Enhanced Cxbladder tests deliver improved diagnostic performance (Pacific Edge Press Release)
"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."
Clinical data
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Cxbladder
over1year
Pacific Edge comments on proposed Novitas LCD (Pacific Edge Press Release)
"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."
Reimbursement
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Cxbladder
over1year
Southern district health region adopts Pacific Edge’s Cxbladder tests (Pacific Edge Press Release)
"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."
Licensing / partnership
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Cxbladder
almost2years
STRATA Study to Validate Cxbladder Utility Reaches 50% Enrolment (Pacific Edge Press Release)
"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."
Enrollment status
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Cxbladder
almost2years
Pacific Edge sees strong interest in Cxbladder at AUA Meeting (Pacific Edge Press Release)
"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."
Clinical data
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Cxbladder
almost2years
LOBSTER clinical trial to advance Cxbladder monitor as a standard of care (Pacific Edge Press Release)
"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."
Trial status
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Cxbladder
over2years
Pacific Edge announces agreement with Northern Health in Australia (Pacific Edge Press Release)
"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."
Licensing / partnership
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Cxbladder
over2years
Cxbladder on the podium at the Annual SUO Meeting in the US (Pacific Edge Press Release)
"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."
Real-world evidence
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Cxbladder