Latest news with #ClinicalLaboratoryImprovementAmendments
Yahoo
25-07-2025
- Health
- Yahoo
MeMed develops rapid infection differentiation test
MeMed has developed MeMed BV Flex, a rapid infection differentiation test that distinguishes between bacterial and viral infections. This test is set to widen the accessibility of MeMed BV to decentralised, Clinical Laboratory Improvement Amendments (CLIA)-waived settings, using a few drops of blood from a finger prick to deliver results within 15 minutes. Designed for near-patient use, the test operates on an improved version of MeMed's current platform. It has been verified in a prospective analytical trial, showing performance on par with laboratory methods. According to the published study, measurements of capillary and venous blood demonstrated high concordance in terms of all the host proteins examined, along with the MeMed BV score, suggesting that there is alignment between the sample types. The company noted that a multi-centre pivotal trial is currently underway to support regulatory submission and confirm clinical accuracy, following initial discussions with the US Food and Drug Administration (FDA). By using host response data, MeMed BV aims to aid physicians with the information needed to make informed treatment decisions and decrease needless antibiotic use. MeMed CEO and co-founder Eran Eden said: 'Accurately and simultaneously measuring multiple proteins from just a few drops of blood, in a rapid and easy-to-use format, has been a long-standing challenge. 'By pairing this breakthrough with machine learning, we've enhanced our platform, which, once cleared, can help extend host-response testing across broader decentralised use. It's a major step toward our next goal of reaching one million patients and enables a plug-and-play engine for our broader pipeline, from MeMed Severity to future sepsis and immune-status assays.' Last year, MeMed secured the FDA's breakthrough device designation for its MeMed Severity test, which is designed to improve the management of patients with suspected acute infections and sepsis. "MeMed develops rapid infection differentiation test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
18-06-2025
- Health
- Yahoo
Visby Medical secures $55m to expedite launch of women's sexual health test
Visby Medical has secured around $55m in its latest funding round, with the potential of reaching $65m, aiming to accelerate the launch and distribution of its at-home women's sexual health test. The test recently received authorisation from the US Food and Drug Administration (FDA). Spearheaded by Catalio Capital Management, the round also saw participation from current investors such as Cedars Sinai Medical Center, ND Capital, Blue Water Life Science Advisors, John Doerr and Pitango Ventures. The test claims to be the first single-use, disposable polymerase chain reaction (PCR) diagnostic that provides results in under 30 minutes via a connected smartphone app. This technology not only improves healthcare accessibility but also maintains patient privacy. The product is set to be available to consumers as of next month through direct-to-consumer channels. Visby also announced that Catalio partner Isaac Ro will join its board as an observer. Moreover, Chuck Alpuche, who currently serves as the chief operating officer (COO) at Imperative Care, will join as an independent director to the board of Visby. Visby Medical CEO and founder Adam de la Zerda said: "We are excited to partner with Catalio Capital Management, a true industry powerhouse, as we advance our mission to transform healthcare through rapid and convenient at-home diagnostics that deliver the same accuracy as traditional PCR machines. "This funding round will enable Visby to deliver on our vision of empowering consumers with reliable and lab-accurate health information from the comfort of their homes, starting with our at-home test for sexually transmitted infections (STIs) for women." Founded in 2012, Visby focuses on infectious disease diagnosis, enabling both physicians and patients to test for infections with lab accuracy. The company's portfolio includes the tests cleared by the US regulator for STIs for point-of-care and home use, as well as for respiratory infections such as Covid-19, flu A, and flu B. Earlier this year, the FDA granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby's PCR test to detect respiratory infections. "Visby Medical secures $55m to expedite launch of women's sexual health test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
22-05-2025
- Business
- Cision Canada
Pictor Establishes U.S. Headquarters and Scales Operations, Revolutionizing Proteomics Testing Amid Regulatory Shift
CARLSBAD, Calif., May 20, 2025 /CNW/ -- Pictor, a global leader in multiplex proteomics solutions, is excited to announce the establishment of its U.S. headquarters in Carlsbad, California, marking a significant milestone in its strategic growth and commitment to advancing cutting-edge solutions for laboratories worldwide. This transformation solidifies Pictor Holdings Inc. as the parent company, which will continue to proudly operate its subsidiaries in New Zealand, India, and Australia. Pictor launches its U.S. operations with strong financial backing, having secured $5 million in seed funding—$3 million from its existing lead investors and $2 million from new U.S.-based investors. This investment underscores the confidence in Pictor's platform and positions the company for rapid growth in the U.S. market. This announcement follows a landmark decision by a U.S. federal court, which struck down the FDA's plan to regulate laboratory-developed tests (LDTs). The court ruling reinforces the current regulatory framework under the Clinical Laboratory Improvement Amendments (CLIA), providing stability in the clinical industry by alleviating potentially costly operational burdens that new regulations would have imposed. "The recent ruling ensures a clear delineation of responsibilities between CLIA and the FDA, providing solution providers like Pictor the certainty needed to equip our partners with an innovative and cost-effective platform," said Jamie Platt, CEO of Pictor Holdings Inc. "This proven regulatory landscape aligns with our ability to offer efficient, affordable proteomics tools to laboratories and healthcare providers, ensuring accessibility for all." Empowering Labs with the Pictor Platform Pictor's products, designed for clinical laboratory use, are poised to help laboratories capitalize on this new era of opportunity. Through its highly flexible, scalable, and cost-effective multiplex proteomics platform, Pictor enables labs to not only develop their own LDTs but also improve workflow efficiency to meet growing demands. Key advantages of the Pictor platform include: Price: Affordable testing made possible through its low-cost PictImager™ platform, standard detection reagents, and under $50 per sample consumable costs. Performance: High-throughput testing achieved with the PictArray™ assays and rapid imaging, with results for 96 samples under four hours. Productivity: A flexible solution adaptable to various sample types and capable of running up to 50 analytes per test. Meeting the Needs of a Changing Healthcare Landscape Anticipated reductions in CMS and Medicare spending are accelerating demand for affordable, accessible testing solutions. Pictor is uniquely positioned to meet this need with its streamlined, scalable platform that delivers unmatched price, performance, and productivity across clinical and research applications. By lowering cost barriers for clinical labs and expanding access to underserved communities, Pictor is advancing its mission to make high-quality proteomics broadly accessible in a shifting healthcare environment. "As the founder and CEO of Mira Precision Health, I have been deeply impressed by Pictor's technology," said Sandra Gunselman, Ph.D. "The platform's flexibility allows us to respond quickly and cost-effectively to healthcare demands. Its speed, affordability, and scalability make it invaluable in advancing innovative diagnostics, particularly for underserved communities." Leadership and Website Launch Pictor's continued momentum is also marked by the announcement of a new Board of Directors, led by Chair Paul Kinnon, CEO Jamie Platt, and seasoned investor executive, Marko Bogoievski. Complementing this strategic leadership, Pictor has also introduced a robust executive team, including Kate Rhodes (COO), Janine McMurdie (CCO), Yoichi Furuya (CSO),and Claire Zimmerman (Director of Business Operations). Coinciding with this announcement is the launch of Pictor's redesigned website. Designed with customer-centricity in mind, the website showcases Pictor's comprehensive testing solutions. The redesigned site provides customers with resources to learn how Pictor's solutions can help power the translation of research discoveries into clinical impact. About Pictor Pictor is a leader in flexible, targeted proteomics, delivering next generation multiplex solutions that empower clinical labs, diagnostic manufacturers, and veterinary providers worldwide. Powered by its patented PictArray™ platform, PictImager™, and AI-powered Pictorial™ software, Pictor delivers deeper insights from a single sample, offering faster, more affordable, and scalable results. From infectious diseases to oncology, Pictor's innovative technology is advancing both human and animal health, enabling breakthroughs in clinical decision-making. Headquartered in San Diego, Pictor Holdings Inc. is committed to driving innovation through solutions designed for unmatched performance, cost efficiency and productivity. Discover how Pictor is shaping the future of proteomics testing at
Yahoo
22-05-2025
- Business
- Yahoo
Pictor Establishes U.S. Headquarters and Scales Operations, Revolutionizing Proteomics Testing Amid Regulatory Shift
CARLSBAD, Calif., May 20, 2025 /CNW/ -- Pictor, a global leader in multiplex proteomics solutions, is excited to announce the establishment of its U.S. headquarters in Carlsbad, California, marking a significant milestone in its strategic growth and commitment to advancing cutting-edge solutions for laboratories worldwide. This transformation solidifies Pictor Holdings Inc. as the parent company, which will continue to proudly operate its subsidiaries in New Zealand, India, and Australia. Pictor launches its U.S. operations with strong financial backing, having secured $5 million in seed funding—$3 million from its existing lead investors and $2 million from new U.S.-based investors. This investment underscores the confidence in Pictor's platform and positions the company for rapid growth in the U.S. market. This announcement follows a landmark decision by a U.S. federal court, which struck down the FDA's plan to regulate laboratory-developed tests (LDTs). The court ruling reinforces the current regulatory framework under the Clinical Laboratory Improvement Amendments (CLIA), providing stability in the clinical industry by alleviating potentially costly operational burdens that new regulations would have imposed. "The recent ruling ensures a clear delineation of responsibilities between CLIA and the FDA, providing solution providers like Pictor the certainty needed to equip our partners with an innovative and cost-effective platform," said Jamie Platt, CEO of Pictor Holdings Inc. "This proven regulatory landscape aligns with our ability to offer efficient, affordable proteomics tools to laboratories and healthcare providers, ensuring accessibility for all." Empowering Labs with the Pictor PlatformPictor's products, designed for clinical laboratory use, are poised to help laboratories capitalize on this new era of opportunity. Through its highly flexible, scalable, and cost-effective multiplex proteomics platform, Pictor enables labs to not only develop their own LDTs but also improve workflow efficiency to meet growing demands. Key advantages of the Pictor platform include: Price: Affordable testing made possible through its low-cost PictImager™ platform, standard detection reagents, and under $50 per sample consumable costs. Performance: High-throughput testing achieved with the PictArray™ assays and rapid imaging, with results for 96 samples under four hours. Productivity: A flexible solution adaptable to various sample types and capable of running up to 50 analytes per test. Meeting the Needs of a Changing Healthcare LandscapeAnticipated reductions in CMS and Medicare spending are accelerating demand for affordable, accessible testing solutions. Pictor is uniquely positioned to meet this need with its streamlined, scalable platform that delivers unmatched price, performance, and productivity across clinical and research applications. By lowering cost barriers for clinical labs and expanding access to underserved communities, Pictor is advancing its mission to make high-quality proteomics broadly accessible in a shifting healthcare environment. "As the founder and CEO of Mira Precision Health, I have been deeply impressed by Pictor's technology," said Sandra Gunselman, Ph.D. "The platform's flexibility allows us to respond quickly and cost-effectively to healthcare demands. Its speed, affordability, and scalability make it invaluable in advancing innovative diagnostics, particularly for underserved communities." Leadership and Website LaunchPictor's continued momentum is also marked by the announcement of a new Board of Directors, led by Chair Paul Kinnon, CEO Jamie Platt, and seasoned investor executive, Marko Bogoievski. Complementing this strategic leadership, Pictor has also introduced a robust executive team, including Kate Rhodes (COO), Janine McMurdie (CCO), Yoichi Furuya (CSO),and Claire Zimmerman (Director of Business Operations). Coinciding with this announcement is the launch of Pictor's redesigned website. Designed with customer-centricity in mind, the website showcases Pictor's comprehensive testing solutions. The redesigned site provides customers with resources to learn how Pictor's solutions can help power the translation of research discoveries into clinical impact. About PictorPictor is a leader in flexible, targeted proteomics, delivering next generation multiplex solutions that empower clinical labs, diagnostic manufacturers, and veterinary providers worldwide. Powered by its patented PictArray™ platform, PictImager™, and AI-powered Pictorial™ software, Pictor delivers deeper insights from a single sample, offering faster, more affordable, and scalable results. From infectious diseases to oncology, Pictor's innovative technology is advancing both human and animal health, enabling breakthroughs in clinical decision-making. Headquartered in San Diego, Pictor Holdings Inc. is committed to driving innovation through solutions designed for unmatched performance, cost efficiency and productivity. Discover how Pictor is shaping the future of proteomics testing at Media Contact:Kelly View original content to download multimedia: SOURCE Pictor Holdings Inc. View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Newsweek
21-05-2025
- Health
- Newsweek
'Important' Alzheimer's Treatment Breakthrough Gets FDA Approval
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) approved the first blood test to detect Alzheimer's disease in what federal officials called an "important step" toward diagnosing and treating the disease earlier. Developed by Fujirebio Diagnostics, the test analyzes the ratio of two proteins in a patient's blood, a measurement that correlates with the presence of amyloid plaques in the brain. These plaques are a hallmark of Alzheimer's and previously required either costly positron emission tomography (PET) scans, or invasive spinal fluid analysis for confirmation. The newly approved test can be used in clinics for patients showing signs of cognitive decline. The results are intended to be interpreted alongside other clinical assessments. Stock image: Jigsaw puzzle representing brain and mental health. Stock image: Jigsaw puzzle representing brain and mental health. Photo by designer491 / Getty Images Why It Matters The approval could accelerate the diagnosis process for a disease that impacts more than 6 million Americans and is expected to affect twice as many by 2050. Early diagnosis is crucial for patients to begin treatment with existing therapies that, while not curative, have been shown to slow cognitive decline. "Alzheimer's disease impacts too many people—more than breast cancer and prostate cancer combined," said FDA Commissioner Marty Makary, in the agency's press release. Diana Dickson, vice president of clinical and regulatory sciences at Fujirebio Diagnostics, noted the "millions" of people impacted by Alzheimer's, in addition to patients. "Millions of patients, family members and caregivers are impacted by this terrible disease and, unfortunately, low-invasive, accessible and affordable diagnostic tools have not been readily available," Dickson told Newsweek in an email. "With this FDA clearance, this test becomes available to physicians through any CLIA [Clinical Laboratory Improvement Amendments] laboratory, which enables access to plasma testing." What To Know The test is meant for use in people already showing signs of cognitive impairment. It should be used as part of a broader diagnostic work-up that includes clinical evaluation and possibly additional imaging. The approval comes as two Alzheimer's drugs—lecanemab and donanemab—are already authorized by the FDA. Both are antibody therapies that target amyloid plaques and are believed to be more effective when administered earlier in the disease's progression. Clinical studies found that the blood test's accuracy was comparable to PET imaging and spinal fluid testing. What People Are Saying Michelle Tarver, of the FDA's Center for Devices and Radiological Health, said: "Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease." Makary said: "Knowing that 10% of people aged 65 and older have Alzheimer's and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients." Dickson said the test is the culmination of more than 30 years of commitment by Fujirebio in the fight against Alzheimer's. "The battle is not nearly over," she continued, "There is much work to be done, not only with this test, but in the development of other novel biomarkers for use in other pathologies and in other neurodegenerative disease. "We continue to be committed to these efforts and are immensely grateful for the partnerships with the pharmaceutical, research and patient communities that have made and continue to make these advances possible." What Happens Next The blood test is now authorized for use in clinical practice, but adoption will depend on further integration into care pathways, insurance coverage decisions and physician familiarity. Dickson said Fujirebio is working to create packaging and inserts to send out their first shipments. The Pennsylvania-headquartered company is finding partners to make sure the clinical data drawn from the tests can be published and discussed within the clinical community. "Finally, we are engaged with various patient advocacy groups and medical specialties to ensure that the public is aware of the test, how it should and should not be used and how results are best interpreted," Dickson said.
