Latest news with #Triage
Otago Daily Times
4 days ago
- Business
- Otago Daily Times
‘Resilient' Pacific Edge announces capital raise
Cancer diagnostics company Pacific Edge has announced a $20 million capital raise in tandem with what it describes as a "resilient" full-year financial result. In a statement yesterday, the listed company said the equity raising was about ensuring it had the cash reserves to capitalise on recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage of its tests. Total revenue was down 16% to $24.6 million while an after tax net loss of $29.9 million was up 1.4%. Total laboratory throughput of Cxbladder tests fell 11.5% on FY24 to 28,894 while commercial tests fell 9.9%. Medicare coverage discontinued in April and Pacific Edge was now focused on regaining coverage for its Triage and Monitor products and obtaining coverage and launch of new products Triage Plus and Monitor Plus. Chairman Chris Gallaher said while the adverse determination was a significant disappointment, it should not overshadow the major strategic progress made over the past year. Cxbladder Triage was included in the American Urological Association's new microhematuria guideline with a grade-A evidence rating, the only biomarker to receive that level of endorsement. With the US Centers for Medicare & Medicaid Services (CMS) announcing a draft price of US$1,018.44 for Cxbladder Triage Plus — a significant premium over the current US$760 price for Pacific Edge's existing tests — the company was positioned for "a rapid acceleration of revenue growth" in the United States once Medicare coverage was achieved, Mr Gallaher said. While confident it would regain coverage for Triage, the company said there were no guarantees as to the timing or outcome of the re-coverage process — it could be delayed or not achieved at all. Chief executive Dr Peter Meintjes said the AUA guideline cemented Pacific Edge's position as the market leader in non-invasive bladder cancer diagnostics. In combination with evidence not considered during the finalisation of the determination, the guideline put the company in a strong position to regain Medicare coverage for Cxbladder Triage. The capital raise comprised a placement of $NZ15 million of new ordinary shares to be offered to selected investors and an offer of $NZ5 million of new shares to retail investors, by way of a share-purchase plan. The share issue was priced at $NZ0.10 per share. Mr Gallaher said the new capital would support the company and its operations for over 12 months, giving Pacific Edge the ability to grow testing volume as it worked to regain coverage through planned Medicare reconsideration requests and challenging the non-coverage of Cxbladder Triage through the Medicare appeals process. All of Pacific Edge's directors and senior management intended to participate in the equity raising.
Digital Trends
12-05-2025
- Entertainment
- Digital Trends
New free-to-play Steam games: Here's how to play them
If you do a quick search for free-to-play games on Steam, you get over 6,700 matches — but that's not enough free games for Valve. The company adds more and more free titles all the time, and this month we've got yet another fresh batch. Covering genres such as multiplayer, horror, first-person combat, open-world adventure, and 3D platformers, Steam has added well over 20 games since the start of May. Here are some of the best-looking ones: Hamster Hustle: a multiplayer tag game where you play as ridiculously colored hamsters running around an elaborate cage. The hamsters also dance. Tankazooka: a 2D platformer about a broken tank that has to use its barrel gun to propel itself up and forward over obstacles. FALARMA – Open World: a pixel art open-world exploration game with missions, side quests, and regular content updates. Triage: a point-and-click adventure/narrative game where you play as a doctor in a small town suffering from a strange outbreak of illness. Sirocco: an early access MOBA that focuses on battleship warfare with 5v5 gameplay. Banshee: a first-person horror game about escaping from a house where all the doors are locked and a murderous banshee is chasing after you. Nanika Game Online: an item-matching, tetris-style game with online multiplayer gameplay. It has a simple style, cute pixel art, and a Japanese name that sort of translates to 'Something Game Online.' If you want to try out any of these games, simply head to the links or throw the name into Steam's search bar. Not every free game is available across all platforms, so make sure to check the icons above the 'Play Game' button. Many titles are Windows-only, but some will also play on macOS and/or SteamOS and Linux. Recommended Videos You can also check the system requirements toward the bottom of the page, though you should be able to play these simple games on just about any setup. If none of these titles interest you, use the filters and top-seller/top-rated tabs available on Steam's search page to check out thousands of other free-to-play games. There's also an 'Under $5' section where you can view the games with the tiniest price tags.
Business Wire
07-05-2025
- Business
- Business Wire
CLARA Analytics Unveils AI-Driven Subrogation Detection for Insurance Claims
SUNNYVALE, Calif.--(BUSINESS WIRE)-- CLARA Analytics ('CLARA'), a leading provider of artificial intelligence (AI) technology for insurance claims optimization, today announced game-changing subrogation detection capabilities that promise to help insurers identify millions in previously missed recovery opportunities. The enhancements to CLARA's flagship CLARA Triage product automatically identify potential subrogation and risk transfer opportunities, providing narrative assessments and numeric scores that help claims adjusters to focus on cases that offer the greatest potential. "The market has a significant gap in regard to subrogation opportunity identification. Our mission is to transform the way claims management teams work with their subrogation partners to deliver transformative financial results." With the National Association of Insurance Commissioners (NAIC) estimating $15 billion in annual missed subrogation opportunities due to manual workflows and documentation issues, CLARA's new technology directly addresses one of the industry's most significant financial challenges. Existing users of CLARA Triage have improved their combined ratios by 2%-5% after a year of claims development. 'CLARA's core values include constant innovation and an obsessive focus on our customers' needs,' said Heather H. Wilson, CEO at CLARA Analytics. 'The market has a significant gap in regard to subrogation opportunity identification. Our mission is to transform the way claims management teams work with their subrogation partners to deliver transformative financial results. Our new subrogation detection capabilities are a major step forward in that journey.' CLARA Triage helps insurance companies, third-party administrators (TPAs), and risk managers at self-insured enterprises to identify and prioritize high-risk claims continuously from first notice of loss until final settlement. It leverages predictive and generative AI technology to assess the severity and complexity of each claim, enabling adjusters to make fully informed decisions and improve overall outcomes. CLARA's large contributory database draws from the experience of multiple carriers, providing a foundation for deep contextual understanding of medical and legal risk. CLARA's new subrogation detection capabilities are a major advancement for the Triage product, leveraging the company's comprehensive insurance claims data with best-in-class GenAI and machine learning models to identify potential recoverable opportunities, score those opportunities based on likely financial returns, and offer AI explainability narratives of potential subrogation scenarios. Triage ingests new claims data as soon as it becomes available, updating scores and alerting claims managers when a key threshold is met. CLARA periodically delivers ROI reports to each of its clients with high adoption of their platform, demonstrating a payback of 500% in most cases, with some achieving even much higher gains. With the release of the new subrogation and risk transfer features in CLARA Triage, the company aims to further increase the value it provides to its customers. 'CLARA's company culture is all about reaching higher, always looking for ways to add more value for our customers,' Wilson continued. 'With these new subrogation and risk transfer detection capabilities, we can help insurers achieve even higher ROI.' About CLARA Analytics CLARA Analytics is the leading AI as a service (AIaaS) provider that improves casualty claims outcomes for insurance carriers, MGAs, reinsurers, and self-insured organizations. The company's platform, applies image recognition, natural language processing, and other AI-based techniques to unlock insights from medical notes, legal demand packages, bills, and other documents surrounding a claim. CLARA's predictive insights give claim professionals augmented intelligence that helps them reduce claim costs and optimize outcomes for the carrier, customer and claimant. CLARA's customers include companies from the top 25 global insurance carriers to large third-party administrators and self-insured organizations. Founded in 2017, CLARA Analytics is headquartered in California's Silicon Valley. For more information, visit and follow the company on LinkedIn and @CLARAAnalytics. All brand names and solution names are trademarks or registered trademarks of their respective companies. Tags: CLARA Analytics, CLARA Triage, subrogation, risk transfer, claims optimization, claims adjusters, claims managers, insurtech, claims, claims management, artificial intelligence, AI, generative AI, GenAI, machine learning, workers compensation, workers comp, predictive analytics, commercial insurance, general liability
Scoop
29-04-2025
- Health
- Scoop
Triage Plus Price Set To Lift Pacific Edge's Economics
Pacific Edge notes today that the draft 'Gapfill' prices for Cxbladder Triage Plus2 have been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of US$1,018.44. When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test. In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026. Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline. Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication. Pacific Edge Chief Executive Dr Peter Meintjes said: 'We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk. 'The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.' Notes: 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+. 3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not. 4 Half year to 30 September 2024. 5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting. 6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126. 7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.
Scoop
28-04-2025
- Health
- Scoop
Medicare LCD Effective; Pacific Edge Seeks Recoverage
Press Release – Pacific Edge Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed at the incoming political appointees within CMS2, HHS3 and OGC4 that included substantial support from the American Urological Association (AUA). Pacific Edge notes the 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination became effective on 24 April 2025 in the US, halting Medicare coverage of Cxbladder tests. Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed at the incoming political appointees within CMS2, HHS3 and OGC4 that included substantial support from the American Urological Association (AUA). However, on Wednesday 23 April 2025 a Pennsylvania District Court Judge ruled that her court lacks jurisdiction to hear Pacific Edge's claim against Medicare Administrative Contractor Novitas and CMS. Meanwhile, the lobbying efforts have not yielded a change to the effective date or retirement of the LCD. Pacific Edge, which currently generates ~60% of its US revenue from Medicare, will now focus on the paths available, which include Medicare appeals for Cxbladder Triage to get paid based on its inclusion in the AUA microhematuria guideline5, despite the non-coverage determination and reconsideration requests for Triage and Monitor. Pacific Edge submitted a reconsideration request for Cxbladder Triage under 'Biomarkers for Oncology' LCD (L35396) on 21 March 2025, a request that has already been deemed valid by Novitas, meaning they will now assess the evidence submitted. It also expects to submit a reconsideration request for Cxbladder Monitor under 'Genetic Testing in Oncology: Specific Tests' (L39365) as soon as possible and request non-coverage to be removed. However, Pacific Edge will not seek re-coverage of Cxbladder Detect as no new evidence has been published that can be submitted for reconsideration. Detect users will be required to move over to Triage in an acceleration of a plan intended to coincide with the commercial launch of Triage Plus. Novitas controls the timeline for these reconsideration requests and is not bound by any maximum period to complete this work. Industry experts typically estimate the time at 6-9 months for a valid submission of a single product with only a small number of new supporting publications and not the protracted period of consultation that results from creating a new LCD as was done with L39365. Regarding Cxbladder Triage Plus, the company will continue to develop, publish and subsequently submit a reconsideration request in line with our previously published roadmap – those activities remain on track. The company will also continue to work with Kaiser Permanente on a peer-reviewed publication confirming the real-world utility of Cxbladder Triage. The preliminary data was presented as a poster at the AUA 2025 annual meeting (April 26–29) in Las Vegas and will be used for future reconsideration requests when published. While the impact of 'Genetic Testing for Oncology: Specific Tests' (L39365) is expected to have a significant impact on testing volume, Pacific Edge expects to continue to bill and receive reimbursement from contracted commercial US payers without interruption, notably Kaiser Permanente, the US Veterans Administration, various Blue Cross Blue Shield plans under the group purchasing agreement and from non-contracted private payers in line with historic reimbursement rates. Similarly, Pacific Edge expects collections from our enhanced patient responsibility and patient assistance programs to continue in line with the rates since the introduction of that program in July 2023. Pacific Edge Chief Executive Dr Peter Meintjes said: 'This finalization is a poor outcome for Medicare patients and urologists, as it removes coverage for guideline-recommended testing and followed a flawed process that failed to review the most-current evidence. 'We are obviously disappointed we have been unable to maintain coverage of our tests in the short term. However, as we noted when the final LCD was published in mid-January 2025, we have planned for this possibility. We will update shareholders as these plans are finalized, though our focus will remain on further evidence generation in parallel with the reconsideration pathway made available to all providers seeking Medicare coverage of their tests.' Notes: 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 Centers for Medicare and Medicaid Services. 3 The Department of Health and Human Services. 4 Office of the General Counsel (of the Department of Health and Human Services). 5 Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining coverage.
