Latest news with #AmericanUrologicalAssociation
Otago Daily Times
3 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.
Yahoo
4 days ago
- Business
- Yahoo
Collaborations for Change: AUA and Pfizer Select Recipients for $1.5 Million Grant Program to Improve Advanced Prostate Cancer Care
BALTIMORE, May 29, 2025 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is excited to announce it has selected seven grant winners to split $1.5 million as part of a collaborative initiative with Pfizer External Research & Grants (ER&G) which is aimed to improve the quality of care for individuals with advanced prostate cancer. Following a joint Request for Proposals (RFP), 23 grant proposals were received from urology and urologic oncology institutions and organizations nationwide. After a rigorous review process, seven innovative projects were awarded grant funding, totaling $1.5 million on behalf of the Pfizer-Astellas Alliance. 'The AUA is proud to once again collaborate with Pfizer in supporting forward-thinking research and education in advanced prostate cancer,' said Mark Gonzalgo, MD, PhD, MBA, chair of education at the AUA. 'This grant initiative continues to foster groundbreaking strategies that address unmet needs in care delivery—from earlier diagnosis to individualized treatment approaches. We commend this year's grant recipients for their commitment to improving outcomes and elevating the standard of care for patients navigating this challenging disease.' Congratulations to the following selected applications: 'Addressing Genomic Disparities in Prostate Cancer: A Quality Improvement Initiative for Equitable Access to Germline and Somatic Testing' – Rohan Garje, MD, Miami Cancer Institute 'Advanced Prostate Cancer Collaboration Advances Rural Equity' – Charles Shelton, MD, The Outer Banks Hospital 'AI-Enhanced Quality Improvement to Optimize Genetic Testing in Advanced Prostate Cancer' – Kenneth Nepple, MD, University of Iowa 'Bridging Gaps in Advanced Prostate Cancer Care: A Quality Improvement Initiative in the Bronx' – Christopher Jakubowski, MD, Montefiore Medical Center 'Boosting Precision: Enhancing Germline and Somatic Testing in Advanced Prostate Cancer' – Guru Sonpavde, MD, AdventHealth Foundation Central Florida 'A Clinical Trial to Address Physician- and Patient-based Barriers to NGS Testing' – Catherine Marshall, MD, MPH, Johns Hopkins University 'Implementing MyNavigator Platform in a High Volume, Rural Advanced Prostate Cancer Practice to Optimize Performance of Multidisciplinary Care Team, Improve Patient Symptom Monitoring, and Collect Real World Data: A Quality Improvement Initiative' – Timothy Richardson, MD, Avident Health, LLC *Pending executed agreements About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 26,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. CONTACT: Corey Del Bianco American Urological Association 443-689-4033 cdelbianco@
The Independent
5 days ago
- Health
- The Independent
Popular over-the-counter drugs have been tied to cancer
Popular over-the-counter drugs used to treat uncomfortable urinary tract infections may come with a potential cancer risk. The drug is called phenazopyridine hydrochloride and is found in many pills - both generic and name-brand - that are used to treat a urinary tract infection. Women are typically at a higher risk than men for those kinds of infections. The pill, many of which sell for less than $15, are used to help reduce pain, burning and irritation associated with the infections. They promise relief in as little as 20 minutes. Phenazopyridine hydrochloride has been used for decades and is not approved by the U.S. Food and Drug Administration. Now, recent studies have raised questions about its use. 'There is no need for this drug,' Rita Jew, who serves as the president of the Institute for Safe Medication Practices, told Bloomberg. 'The data available from epidemiological studies are inadequate to evaluate the relationship between human cancer and exposure specifically to phenazopyridine hydrochloride,' the report said. There are more than 8 million related visits to healthcare providers in the U.S. each year to treat a UTI, according to the American Urological Association. Many people experience repeat infections, and around 60 percent of women and 12 percent of men will have at least one UTI during their lifetimes. But, even the labels on the drugs recognize that there is risk associated with the products. 'This product contains Phenazopyridine hydrochloride, known to the State of California to cause cancer,' the AZO label says. 'Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted,' the URISTAT Pain Relief Tablet box notes. Neoplasia is the abnormal growth of cells. It was also listed by the New Jersey Department of Health and Senior Service as a hazardous substance in 2001. Bloomberg also flagged that Phenazopyridine hydrochloride has been blamed for masking serious infections, slowing breathing, upset stomach and reddish-orange urine One adverse effect, known as methaemoglobinaemia, is rare but can be life-threatening. Still, even physicians may not have heard about the ties to cancer. 'It's the first time I'm even hearing about this. I'm totally unaware,' New York-based gynecologist Steven Goldstein told Bloomberg.
Fox News
21-05-2025
- Health
- Fox News
DR. MARC SIEGEL: Biden's prostate cancer diagnosis reveals dangerous flaw in screening guidelines
If there is one thing that the COVID pandemic taught us, it was the lack of flexibility, nimbleness and the frequent inaccuracy or out of datedness of superimposed guidelines. I must confess that as a practicing internist for many years, I have never strictly adhered to guidelines and simply used them to guide me. Medicine is and always has been an art to be practiced on an individual basis. One of the guidelines that has bothered me the most is the U.S. Preventive Services Task Force Guideline – in use since 2012 -- not to recommend routine Prostate Specific Antigen use in prostate cancer screening. And even the American Urological Association doesn't recommend routine screening over the age of 70. Studies have shown that use of the PSA has fallen off likely in men over the age of 40 as a result of the USPSTF recommendation. This is particularly disturbing considering that there are over 300,000 new cases of prostate cancer in the U.S. diagnosed every year, with over 35,000 deaths, many of which may be preventable with earlier diagnosis. So it is disturbingly possible that former President Biden's spokesperson is telling the truth when he says that he wasn't screened for prostate cancer in over a decade prior to his current diagnosis of aggressive metastatic disease. Perhaps he and his doctors were just rigidly following an outdated and ill-conceived guideline. But this revelation, if true, is just as disturbing as if the Biden White House were hiding a timelier earlier diagnosis from the American public, just as they have apparently hidden other health realities regarding the former president. Delay and guessing in the dark is simply not how I, and many other internists and urologists, practice medicine. The PSA itself tells us when it trends upward, often when it increases over 4, that there is something going on in the prostate. The rise may or may not be due to prostate cancer. When combined with a "free PSA," if low, the likelihood of prostate cancer increases. We are also on the verge of genetic testing and liquid biopsies (blood tests) which will increase the accuracy of prostate cancer screening and we already have useful biomarker screening tests for prostate cancer in the urine. Luckily, despite the fact that current screening guidelines are not up-to-date or useful, I can still order a PSA and have Medicare cover it for any age if I say the test is medically necessary. I need to know that information, combined with a digital rectal exam looking for nodules, to know what to do next regardless of my patient's age. If either test is abnormal, I can then choose to proceed to an MRI of the prostate, which has become more accurate at looking for prostate cancer as the test has evolved and advanced. An MRI result can direct a urologist as to whether a biopsy is necessary and where in the prostate to direct this biopsy. If a patient has prostate cancer, there are many treatment options available, depending on the stage and aggressivity. These treatments have also advanced over the years and are better tolerated with fewer side effects, which means they may be tolerated by men of older ages and in poorer health. If a cure is possible, then either robotic radical prostatectomy or various forms of radiation treatments are considered. And if the prostate cancer is metastatic, as in President Joe Biden's case, hormone therapy to target testosterone (which may be causing the tumor to grow), may be used or combined with other treatments, including targeted therapies, immunotherapy, or chemotherapy. There are even studies which show that it may improve outcome to still remove the prostate even in some advanced cases. Many critics are saying that a president of the United States should have the most aggressive prostate cancer screening regardless simply because he is president. But I am saying that all men over the age of 45 should have this screening. Period. Regardless of age. Medical knowledge is power and what I do with the information I acquire to help my patient is the art of medicine. Not knowing is never the correct answer.
Yahoo
21-05-2025
- Business
- Yahoo
Prostate Cancer Diagnostics Solution Market Trends, Challenges and Future Outlook
Prostate Cancer Diagnostics Solution Market Overview 2025-2034 Luton, Bedfordshire, United Kingdom, May 21, 2025 (GLOBE NEWSWIRE) -- Global Prostate Cancer Diagnostics Solution Market The global prostate cancer diagnostics solution market is undergoing a significant transformation, propelled by technological advances, improved patient awareness, and increased healthcare spending. In 2024, the market size is valued at approximately USD 4.18 billion, and it is forecast to reach USD 10.84 billion by 2034, reflecting a strong CAGR of 10%. This growth is primarily fueled by the increasing incidence of prostate cancer globally, driven in part by an aging population, better screening coverage, and enhancements in molecular and imaging-based diagnostics. Get a Sample PDF Brochure: Prostate cancer remains one of the most prevalent malignancies among men, especially in North America and Europe. While early detection significantly improves prognosis, traditional diagnostic methods such as PSA screening and manual biopsies face criticism for low specificity and overdiagnosis. In response, the market is witnessing a shift toward precision diagnostics using biomarkers, genetic assays, and advanced imaging systems. Market Growth Drivers The market is influenced by several factors. First, the growing awareness around early screening programs, especially in developed nations, has led to a significant uptick in test volumes. Public health campaigns and evolving guidelines from organizations like the American Urological Association (AUA) and European Association of Urology (EAU) encourage age-appropriate prostate screening. Secondly, technology has improved both the sensitivity and specificity of diagnostic tools. Multiparametric MRI, PSMA-based imaging, liquid biopsy, and AI-assisted pathology have reduced false positives and enabled targeted biopsies. Healthcare providers are increasingly integrating prostate-specific biomarkers such as PCA3, 4Kscore, SelectMDx, and PHI (Prostate Health Index) into diagnostic workflows. Molecular diagnostics and genomic profiling are also gaining traction for risk stratification and treatment planning. For instance, gene expression panels help differentiate between indolent and aggressive tumors, enabling clinicians to tailor active surveillance or treatment strategies. Emerging markets in Asia-Pacific, Latin America, and the Middle East are also contributing to market expansion. Improved healthcare infrastructure, greater access to insurance, and the establishment of private diagnostic centers have expanded access to prostate cancer testing beyond urban centers. Governments in countries like China, India, and Brazil are prioritizing cancer screening under national health plans, further accelerating adoption. Challenges and Constraints Despite promising growth, the prostate cancer diagnostics market faces several challenges. Overdiagnosis and overtreatment remain concerns, particularly in cases where low-risk tumors are detected. Invasive diagnostic procedures, such as transrectal ultrasound (TRUS)-guided biopsies, are associated with discomfort, infection risk, and high costs. Moreover, the accessibility of advanced imaging and molecular testing remains limited in low-income regions. Regulatory barriers also affect product adoption. Diagnostic test developers must navigate complex approval processes, such as FDA clearance and CE marking, which can delay commercialization. Furthermore, reimbursement coverage for newer tests varies significantly across markets, limiting patient access to cutting-edge solutions in some areas. Browse full Report - Market Segmentation By Product Type Imaging continues to dominate the market owing to its role in tumor localization and staging. This includes multiparametric MRI and PSMA-PET, which are essential for visualizing high-risk tumors. Biomarkers, on the other hand, are rapidly gaining popularity, especially with non-invasive urine and blood-based tests that offer high specificity. Biopsy devices remain essential, particularly for confirmatory diagnosis. The prostate cancer diagnostics market is segmented into imaging, biomarkers, and biopsy devices. Product Type 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Imaging 40% 4.34 9.5% Biomarkers 35% 3.79 10.2% Biopsy Devices 25% 2.71 10.8% By Application Screening forms the foundation of prostate cancer prevention strategies, accounting for the largest market share. Diagnosis is growing steadily with the adoption of precision-guided biopsy methods. Monitoring applications are increasingly important in active surveillance models and recurrence tracking. Applications include screening, diagnosis, and monitoring. Application 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Screening 45% 4.88 9.8% Diagnosis 35% 3.79 10.1% Monitoring 20% 2.17 10.5% By End User Hospitals are the largest end users due to their integrated imaging, pathology, and urology departments. Diagnostic laboratories follow closely, with specialized labs offering advanced biomarker panels and gene sequencing. Research institutes contribute to market development through clinical trials and new test validation. End users encompass hospitals, diagnostic laboratories, and research institutes. End User 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Hospitals 50% 5.42 9.9% Diagnostic Labs 35% 3.79 10.2% Research Institutes 15% 1.63 10.4% By Technology Immunohistochemistry techniques remain widely used due to their cost-effectiveness and accessibility. Molecular diagnostics are growing rapidly, especially with NGS and PCR-based tests enabling more accurate diagnosis. Imaging techniques continue to evolve, with AI-assisted MRI and PSMA scans reshaping early detection. Technologies include immunohistochemistry, molecular diagnostics, and imaging techniques. Technology 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Immunohistochemistry 40% 4.34 9.5% Molecular Diagnostics 35% 3.79 10.2% Imaging Techniques 25% 2.71 10.8% By Distribution Channel Direct sales dominate the market as most products are sold directly to hospitals and diagnostic centers. Distributors play a key role in reaching secondary markets and mid-sized labs. Online sales are growing quickly, particularly for biomarker kits and reagent supplies, driven by digital procurement platforms. Distribution channels comprise direct sales, distributors, and online sales. Distribution Channel 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Direct Sales 50% 5.42 9.9% Distributors 30% 3.25 10.3% Online Sales 20% 2.17 10.5% Recent Developments EDX Medical Group has developed an AI-driven prostate cancer supertest that measures over 100 biomarkers using blood and urine samples, achieving 96% accuracy. This test is expected to revolutionize early detection and personalized treatment plans . Telix Pharmaceuticals received FDA approval for Gozellix, a prostate cancer screening agent designed for PET scanning of PSMA-positive lesions, offering a longer shelf life and enhanced clinical utility . Key Players Abbott Laboratories Siemens Healthineers Roche Diagnostics Hologic, Inc. Myriad Genetics, Inc. OPKO Health, Inc. Genomic Health (Exact Sciences Corporation) MDxHealth Beckman Coulter, Inc. Thermo Fisher Scientific Inc. Market Outlook In the next decade, the prostate cancer diagnostics market is expected to continue evolving toward non-invasive, high-accuracy, and personalized testing paradigms. AI integration will play a pivotal role in radiology and pathology, helping clinicians interpret results faster and more accurately. The convergence of imaging, molecular diagnostics, and clinical decision support tools is paving the way for comprehensive, data-driven diagnostic ecosystems. Industry players are likely to invest in integrated diagnostic platforms, point-of-care testing innovations, and strategic collaborations with research institutions. Startups and biotech firms are actively exploring liquid biopsy techniques and next-generation sequencing (NGS) for early detection and risk profiling. At the same time, healthcare systems are adopting risk-based screening models to optimize resources and minimize overtreatment. With increased emphasis on preventive care and patient-centered medicine, prostate cancer diagnostics are poised to become more accessible, reliable, and cost-effective worldwide. Stakeholders that prioritize innovation, regulatory agility, and affordability are expected to capture significant market share in this rapidly expanding field. This report is also available in the following languages : Japanese (前立腺がん診断ソリューション市場), Korean (전립선암 진단 솔루션 시장), Chinese (前列腺癌诊断解决方案市场), French (Marché des solutions de diagnostic du cancer de la prostate), German (Markt für Prostatakrebsdiagnostiklösungen), and Italian (Mercato delle soluzioni diagnostiche per il cancro alla prostata), etc. Download Full PDF Sample Copy of Market Report @ Related reports – Handheld Acoustic Camera Market The global handheld acoustic camera market is valued at approximately $120 million, reflecting a growing interest in innovative sound visualization technologies. 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Dental Polishing Paste Market The global dental polishing paste market is projected to reach approximately $335 million in 2024, with a steady growth trajectory anticipated over the next decade. By 2034, the market value is expected to expand to around $520 million, reflecting a compound annual growth rate (CAGR) of approximately 4.4% during the forecast period of 2025–2034. Dental Acid Etching Agent Market The global dental acid etching agent market is projected to reach a value of approximately $350 million in 2024, driven by the rising demand for cosmetic dentistry and advancements in dental materials. During the forecast period from 2025 to 2034, the market is anticipated to grow at a CAGR of 6.5%, driven by increasing dental care awareness, technological innovations, and the growing prevalence of dental disorders. Root Canal Lubricant Market The global root canal lubricant market is valued at approximately $180 million in 2024, with projections indicating a robust growth trajectory, reaching an estimated $300 million by 2034. This reflects a Compound Annual Growth Rate (CAGR) of around 5.1% over the forecast period from 2025 to 2034. Laryngeal and Tracheal Stents Market The global laryngeal and tracheal stents market is valued at approximately $450 million. Projections indicate significant growth, with an estimated market value of $1.1 billion by 2034, signaling a robust expansion driven by advancements in medical technology and increasing prevalence of respiratory conditions. Pharmaceutical Grade Medium Chain Triglyceride (MCT) Market The global pharmaceutical-grade medium chain triglyceride (MCT) market is valued at approximately $550 million, fueled by rising health awareness and the increasing use of MCT in dietary supplements and clinical nutrition. The market is projected to grow significantly, reaching an estimated value of $1.2 billion by 2034, reflecting a robust compound annual growth rate (CAGR) of 8.1% over the forecast period from 2025 to 2034. Hydroxyethyl Starch API Market The global Hydroxyethyl Starch (HES) API market is estimated at approximately USD 675 million in 2024, with a projected value reaching around USD 1.1 billion by 2034. This growth reflects a robust compound annual growth rate (CAGR) of about 5.1% for the period from 2025 to 2034. Pet Wellness Exams Market The global pet wellness exams market is expected to reach a value of approximately $3.5 billion in 2024, driven by increasing pet ownership and a growing emphasis on preventive healthcare. The projected market value is estimated to rise to around $5.8 billion by 2034, reflecting a robust demand for wellness services in the pet care sector. Enteric Pathogen Test Kits Market The global market for enteric pathogen test kits is valued at approximately $1.2 billion in 2024, driven by heightened consumer awareness regarding food safety and stringent regulatory frameworks. The market is projected to reach around $2.3 billion by 2034, reflecting robust growth opportunities in both emerging and established markets. CONTACT: Contact Data Irfan Tamboli (Head of Sales) Phone: + 1704 266 3234 Email: sales@ in to access your portfolio
