Latest news with #ClinicalLaboratoryImprovementAmendments
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.
Yahoo
24-04-2025
- Business
- Yahoo
Overture Life Secures $57M in Total Funding and Earns U.S. CLIA License to Deliver Reliable, Scalable IVF Automation
Overwater Ventures, GV, and Khosla Ventures invest in a rigorous clinical approach that raises throughput for fertility clinics, expands access, and empowers women to plan on their own terms PALO ALTO, Calif., April 24, 2025--(BUSINESS WIRE)--Overture Life today announced a $20.6 million strategic round, bringing its total funding to $57 million from leading industry investors, to support additional clinical research and product development designed to make IVF affordable to more people. The company is also announcing its newly achieved CLIA (Clinical Laboratory Improvement Amendments) license in the United States to meet federal clinical laboratory standards for m|z, its AI-powered, non-invasive metabolomic test for embryo selection. These latest milestones reinforce Overture's commitment to demonstrating scientific rigor, securing regulatory support, and prioritizing patient safety. They also pave the way for the launch of DaVitri, an advanced embryology platform that automates egg freezing (vitrification) and embryo warming under reproducible, data-driven protocols. For too long, IVF has been inaccessible for too many people, with inefficiencies driving up costs. Since 2017, Overture has modernized the core technology involved in IVF through proprietary software, robotics, microfluidics and rigorous scientific validation, documented in peer-reviewed publications, scientific presentations, and, most importantly, two healthy, live births resulting from the use of its technology. Its newest platform, DaVitri, addresses essential lab steps that historically rely on manual precision. By standardizing these procedures with precise timing and controlled cryoprotectant exposure, DaVitri has demonstrated improved oocyte survival rates in early clinical evaluations, potentially reducing repeated IVF cycles that can drain resources and emotional energy. In addition, its streamlined, gentler freezing process helps clinics maintain consistent lab results, allowing embryologists to handle more cycles without compromising quality. "This new funding allows us to accelerate our expansion of IVF capabilities and demonstrates the value of operating within a CLIA-licensed laboratory environment, highlighting not only our technological leadership but also our commitment to the highest standards of clinical validation," said Hans Gangeskar, CEO of Overture Life. "DaVitri has already shown potential to significantly increase clinical throughput while ensuring reproducibility in critical freezing and warming processes, allowing embryologists to prioritize personalized patient care. Our approach is rigorous and evidence-based because we understand how deeply personal this journey is for families." "Automation and standardization in the embryology lab is an exciting step towards optimizing efficiency and efficacy in IVF. It allows us to deliver consistent and excellent care, while still giving us the flexibility to fine-tune protocols for our patients," said Serena H. Chen, MD, a Reproductive Endocrinologist at CCRM Fertility of NJ. "We're very excited about the potential to serve more patients by increasing lab capacity without sacrificing quality." This strategic round, supported by Overwater Ventures, GV (formerly Google Ventures), and Khosla Ventures, reflects a deep conviction in Overture's science-led mission: to expand fertility access by making IVF labs more reproducible, efficient, and ultimately less cost-intensive. "Fertility intersects healthcare, economics, and the most personal of human wishes," said Kristina Simmons, Founder and Managing Partner at Overwater Ventures. "Women have long faced irreversible biological timelines, and by making egg freezing cheaper, easier, and more clinically effective and predictable, it allows women and families to regain choice and opportunity. Overture's platform provides a precise alternative that can run more cycles successfully, enabling women to freeze their eggs or pursue IVF on their own terms and timelines. By fitting the embryology protocols into a compact, desk-sized system, Overture is reinventing egg freezing and IVF for a better patient experience and strong, clinically reproducible outcomes with proven science." About Overture Life Overture Life integrates engineering, reproductive medicine, and regulatory-grade validation to modernize embryology lab procedures, particularly egg freezing and embryo handling, in ways that lower repeated cycles, increase throughput, and reduce the overall cost of IVF. With R&D in Spain and active U.S. operations, including a CLIA-licensed laboratory for non-invasive embryo selection, Overture unites robotics, analytics, and clinical rigor to deliver tools that clinics and patients can trust. The company's DaVitri platform aims to boost reliability and consistency in IVF, giving women and families worldwide more control over their fertility timelines. Overture's backers include Overwater Ventures, GV, Khosla Ventures, Octopus Ventures and others committed to advancing the future of fertility. View source version on Contacts Media Contact overture@ Sign in to access your portfolio
Business Wire
24-04-2025
- Business
- Business Wire
Overture Life Secures $57M in Total Funding and Earns U.S. CLIA License to Deliver Reliable, Scalable IVF Automation
PALO ALTO, Calif.--(BUSINESS WIRE)--Overture Life today announced a $20.6 million strategic round, bringing its total funding to $57 million from leading industry investors, to support additional clinical research and product development designed to make IVF affordable to more people. The company is also announcing its newly achieved CLIA (Clinical Laboratory Improvement Amendments) license in the United States to meet federal clinical laboratory standards for m|z, its AI-powered, non-invasive metabolomic test for embryo selection. These latest milestones reinforce Overture's commitment to demonstrating scientific rigor, securing regulatory support, and prioritizing patient safety. They also pave the way for the launch of DaVitri, an advanced embryology platform that automates egg freezing (vitrification) and embryo warming under reproducible, data-driven protocols. For too long, IVF has been inaccessible for too many people, with inefficiencies driving up costs. Since 2017, Overture has modernized the core technology involved in IVF through proprietary software, robotics, microfluidics and rigorous scientific validation, documented in peer-reviewed publications, scientific presentations, and, most importantly, two healthy, live births resulting from the use of its technology. Its newest platform, DaVitri, addresses essential lab steps that historically rely on manual precision. By standardizing these procedures with precise timing and controlled cryoprotectant exposure, DaVitri has demonstrated improved oocyte survival rates in early clinical evaluations, potentially reducing repeated IVF cycles that can drain resources and emotional energy. In addition, its streamlined, gentler freezing process helps clinics maintain consistent lab results, allowing embryologists to handle more cycles without compromising quality. 'This new funding allows us to accelerate our expansion of IVF capabilities and demonstrates the value of operating within a CLIA-licensed laboratory environment, highlighting not only our technological leadership but also our commitment to the highest standards of clinical validation,' said Hans Gangeskar, CEO of Overture Life. 'DaVitri has already shown potential to significantly increase clinical throughput while ensuring reproducibility in critical freezing and warming processes, allowing embryologists to prioritize personalized patient care. Our approach is rigorous and evidence-based because we understand how deeply personal this journey is for families.' 'Automation and standardization in the embryology lab is an exciting step towards optimizing efficiency and efficacy in IVF. It allows us to deliver consistent and excellent care, while still giving us the flexibility to fine-tune protocols for our patients," said Serena H. Chen, MD, a Reproductive Endocrinologist at CCRM Fertility of NJ. 'We're very excited about the potential to serve more patients by increasing lab capacity without sacrificing quality.' This strategic round, supported by Overwater Ventures, GV (formerly Google Ventures), and Khosla Ventures, reflects a deep conviction in Overture's science-led mission: to expand fertility access by making IVF labs more reproducible, efficient, and ultimately less cost-intensive. 'Fertility intersects healthcare, economics, and the most personal of human wishes,' said Kristina Simmons, Founder and Managing Partner at Overwater Ventures. 'Women have long faced irreversible biological timelines, and by making egg freezing cheaper, easier, and more clinically effective and predictable, it allows women and families to regain choice and opportunity. Overture's platform provides a precise alternative that can run more cycles successfully, enabling women to freeze their eggs or pursue IVF on their own terms and timelines. By fitting the embryology protocols into a compact, desk-sized system, Overture is reinventing egg freezing and IVF for a better patient experience and strong, clinically reproducible outcomes with proven science.' Overture Life integrates engineering, reproductive medicine, and regulatory-grade validation to modernize embryology lab procedures, particularly egg freezing and embryo handling, in ways that lower repeated cycles, increase throughput, and reduce the overall cost of IVF. With R&D in Spain and active U.S. operations, including a CLIA-licensed laboratory for non-invasive embryo selection, Overture unites robotics, analytics, and clinical rigor to deliver tools that clinics and patients can trust. The company's DaVitri platform aims to boost reliability and consistency in IVF, giving women and families worldwide more control over their fertility timelines. Overture's backers include Overwater Ventures, GV, Khosla Ventures, Octopus Ventures and others committed to advancing the future of fertility.
