Latest news with #LDTs
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
Yahoo
16-05-2025
- Business
- Yahoo
Precipio Inc (PRPO) Q1 2025 Earnings Call Highlights: Strong Revenue Growth and Operational ...
Release Date: May 15, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Precipio Inc (NASDAQ:PRPO) reported a 43% year-over-year increase in Q1 2025 revenues, reaching $4.9 million, indicating sustained demand and growth in pathology services. Adjusted EBITDA improved by 92%, with a loss of $108,000 compared to a $1.4 million loss in Q1 of the previous year, showcasing enhanced operational efficiency. Pathology division test volume increased by 46% and revenue grew by 53% year-over-year, with 11 new physicians utilizing their services, reflecting strong market trust. Gross margins for the Pathology division increased from 24% to 42% year-over-year, driven by operational efficiency and scale. Precipio Inc (NASDAQ:PRPO) received MolDx approval for next-generation sequencing (NGS) testing, which is expected to increase revenue and cash flow by approximately $0.25 million per quarter. Q1 2025 revenues decreased by 9.5% from Q4 2024, attributed to typical seasonal patterns in the healthcare industry. The FDA ruling on laboratory developed tests (LDTs) caused delays in customer adoption of Precipio Inc (NASDAQ:PRPO)'s technology, impacting growth. Product division revenues were flat from Q4 2024 to Q1 2025, with customer validation timelines largely out of the company's control. The company experienced a temporary disruption in billing and collections due to a cyber-attack on Change Healthcare in early 2024. Precipio Inc (NASDAQ:PRPO) is still pursuing the remaining $1 million from the CARES Act employee retention credit, indicating potential delays in receiving these funds. Warning! GuruFocus has detected 2 Warning Signs with PRPO. Q: Can you explain the reasons behind the sequential quarter-over-quarter revenue decline from Q4 2024 to Q1 2025? A: Ilan Danieli, CEO: The decline is attributed to typical seasonal patterns in the healthcare industry, particularly in diagnostics. Insurance plans reset on January 1, leading patients to postpone nonurgent testing until out-of-pocket costs are absorbed, impacting test volumes and collections. This creates a temporary dip in revenue and cash flow, which we anticipated. We are already seeing a rebound in Q2 and expect to return to positive cash flow in either Q2 or Q3 of this year. Q: How did the overturning of the FDA ruling on laboratory-developed tests (LDTs) impact your business? A: Ilan Danieli, CEO: The FDA ruling on LDTs, which was overturned in March, had caused prospective customers to delay plans to bring our technology in-house. With the ruling overturned, some customers have resumed their interest, and we expect consistent growth in product revenues starting in Q2. Q: What are the expected financial impacts of the recent MolDx approval for your next-generation sequencing (NGS) testing? A: Ilan Danieli, CEO: The MolDx approval allows us to bill and collect cash for NGS tests from Medicare patient samples in MolDx-governed states, which we previously could not. This is expected to increase revenue and cash by approximately $0.25 million per quarter based on current case volume. Q: Can you elaborate on the improvements in gross margins for both the Pathology and Product divisions? A: Ilan Danieli, CEO: Pathology gross margins increased from 24% to 42% year-over-year due to increased test volumes and scale efficiencies. Product division margins improved from 37% to 51% due to better production efficiencies and cost management. Overall, company gross margins rose from 27% to 43%. Q: What are the strategic investments that have driven margin growth? A: Ilan Danieli, CEO: We have invested in state-of-the-art equipment and talent. Equipment investments ensure high-quality outcomes, and as volume increases, the fixed cost per sample decreases, improving margins. Investment in staff training enhances efficiency and accuracy, directly impacting financial performance. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
02-04-2025
- Health
- Yahoo
Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don't exist or aren't precise enough. Opioid and other drug tests sometimes give false positives or negatives and more sensitive, lab-developed tests are needed to confirm or refute results. Those are just some of the uses of lab-developed tests — most often called LDTs — which are in total administered 100,000 or more times a year in labs that developed them all around the country. And this week a federal judge answered at least one of the questions about how they should be overseen. Judge Sean D. Jordan from the U.S. District Court for the Eastern District of Texas foiled the U.S. Food and Drug Administration's plan put forth under the Biden administration to regulate them like medical devices. The court decision boiled down to whether the tests are a product, like a medical device or the commercial tests that are sold to health care providers and consumers and do fall under FDA purview, or they are a service. Deciding they are a service, since LDTs are developed in one lab and only used there, Jordan vacated as administrative overreach the new rule the FDA announced last year. The nation's largest pathologist association, laboratories and hospitals and other groups are celebrating a decision they say will keep specialized tests affordable and, crucially, available. It's an issue that potentially affects hundreds of thousands of patients, because LDTs are developed to provide more targeted data on diagnosis and treatment than a mass-produced test. And they are often the only test available for certain conditions, said Dr. Jonathan Genzen, chief medical officer and senior director of government affairs for ARUP Laboratories in Salt Lake City. 'For patients, this is incredibly good news. This means that labs will not be saddled with very high administrative burden or cost — all the things that regulation leads to," Dr. Donald Karcher, president of the College of American Pathologists, told Deseret News. Genzen described two pathways in the U.S. for diagnostic testing: The FDA-cleared pathway where manufacturers produce commercial kits that hospitals use and the LDTs created for use in a single laboratory. The latter have been regulated by the Centers for Medicare and Medicaid Services under Clinical Laboratory Improvement Amendments or CLIA, a law that for decades has set laboratory and LDT standards. LDTs meet clinical guidelines, Genzen said. 'They are designed and operated by highly skilled professionals who meet federal requirements and maintain compliance with CLIA' standards, he said. One analogy sometimes used to explain the difference between commercial tests and an LDT is that of a prepackaged meal like a TV dinner and one that is well-crafted by a good cook who knows the needs and preferences of the people who will be eating it and takes responsibility for it, Genzen said. LDTs are like the latter. The FDA already regulated commercial tests and wanted to regulate the LDTs, too, finalizing a rule last year. That led to legislative proposals that didn't gain traction — many believe Congress will ultimately have to decide how LDTs are regulated — and different lawsuits. Separate lawsuits filed by the American Clinical Laboratory Association and the Association for Molecular Pathology were heard together in the Eastern District of Texas, with oral arguments in mid-February, leading to this week's decision. 'This ruling ensures that hospital based labs are able to continue to develop innovative and high-quality tests that provide physicians with important clinical information to help diagnose and treat patients,' Jason Kleinman, American Hospital Association director of federal relations, said in a written statement. 'The LDT final rule would have stifled medical innovation and dramatically increased regulatory burden and costs for both hospitals and the federal government.' Karcher said that the now-dismissed rule from FDA had five stages, with the first due in May and final implementation to be completed in May 2028. Genzen said ARUP is an example of a clinical laboratory that develops tests as part of its test menu. 'We often do that because there is no commercially available test either because it is for a rare disorder or sometimes because what is commercially available doesn't meet the requirements of clinical guidelines or of an institution's own health care practitioners.' Though the money burden of the final rule has been criticized, Karcher said money isn't the issue. But it would have impacted whether patients have access to the tests. 'The only reason I mention costs is that the FDA rule would have made it so expensive to develop even one laboratory-developed test that many labs wouldn't be able to afford it anymore. They would just stop offering those tests.' Karcher and Genzen both told Deseret News that cancer tests are an example of a condition needing LDTs, since new gene variants often lack FDA-approved tests, as are orphan and rare disorders, but there aren't enough cases to spur commercial development. And sometimes more precision is needed than a commercial test can provide. Per Karcher, there are around 100,000 LDTs in the U.S., with thousands of unique tests, though a number of labs may develop their own versions of a test for the same purpose or condition, so it's hard to get an exact count. He estimated there are LDTs related to 2,000-3,000 purposes nationwide. Lab-created tests account for about 4% of all the lab tests ordered by physicians. They also meet clinical guidelines and are carefully vetted by experts, said Genzen, who is also a professor in the University of Utah Department of Pathology. Genzen said LDTs existed long before either the FDA or the CLIA law. LDTs are operated by 'highly skilled professionals who are either board-certified physicians or PhD-level laboratory scientists who meet federal requirements,' noting that federal CLIA law dictates the oversight of such testing. Labs also must test their results against other labs to make sure they perform well. It's a very serious responsibility, Genzen said. 'As a CLIA laboratory director, I am legally responsible and medically liable for all the testing in my laboratory.' The question of who will regulate LDTs in the future may not be settled, however. The court sent the question back to the U.S. Secretary of Health and Human Services. A decision on whether to appeal will be made is now up to Robert F. Kennedy Jr.'s and the Trump administration's authority. There are mixed opinions on who should have ultimate oversight, even among laboratories and their staff. Some want it left with the Centers for Medicare and Medicaid Services and the CLIA law. Some support FDA regulation. And many, including Karcher, believe that Congress will ultimately have to deal with the issue. Genzen said that the clinical lab community, legislative staff and the Trump administration now have an opportunity to work together to find a workable solution for LDT regulation. Many see a need to address concerns about test quality and transparency, with which pathologists seem to agree is high-quality, but not well explained to those outside the labs doing LDTs. Genzen said he hopes the coming discussions allay some of those concerns. But since the FDA's proposed rule could have caused labs to stop offering essential testing services because of complexity and cost, he said he's hoping for less costly regulation solutions that meet quality goals. 'The clinical laboratory community is somewhat fragmented into many different specialties, and part of the conundrum has been that diversity of opinion has often been challenging to navigate for legislators and the administration,' Genzen said. 'I think having gone through this experience together collectively, it is an opportunity to think about how we can work together going forward.'
Yahoo
01-04-2025
- Health
- Yahoo
Association for Molecular Pathology Celebrates U.S. District Court's Decision to Vacate FDA Rule on Laboratory-Developed Test Procedure Regulation
Professional society will continue to work with stakeholders to develop a more effective and efficient legislative regulatory framework that ensures high-quality patient care while fostering rapid innovation and the promise of new diagnostic technologies ROCKVILLE, Md., March 31, 2025 /PRNewswire/ -- The Association for Molecular Pathology, the premier global molecular diagnostic professional society, and pathologist Michael Laposata, M.D., Ph.D., today announced a favorable ruling in their lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures. The ruling by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas granted AMP's motion for summary judgment and vacated the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. AMP President Jane S. Gibson, Ph.D., is a Pegasus-awarded professor of pathology, chair of the Department of Clinical Sciences and director of molecular diagnostics at the University of Central Florida College of Medicine. "AMP is extremely pleased with the court's clear and decisive ruling in our favor, and we hope this will finally end the FDA's attempts to exert an unwarranted overreach of authority of LDTs," said Gibson. "This judgment is a significant victory for our members and for patients across the country. The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans." For decades, LDTs have led to significant clinical advancements and diagnostic breakthroughs in rare and infectious diseases, human genomics, oncology biomarker testing and more. They are often created in response to recent medical advances and unmet clinical needs, and have been instrumental for early and precise diagnosis, disease monitoring and treatment guidance. LDTs are designed, developed, validated, performed and interpreted by highly trained medical and scientific experts in regulated clinical laboratories. Importantly, LDTs are not manufactured, packaged or commercially distributed like medical devices. Eric Konnick, M.D., is AMP's Professional Relations Committee chair and an associate professor and the associate director of the Genetics and Solid Tumor Laboratory at the University of Washington Department of Laboratory Medicine and Pathology. "The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe, and would have led to extensive additional requirements in addition to the existing CLIA regulations," said Konnick. "AMP members continue to work with key stakeholders to develop a more effective and efficient legislative framework that clarifies oversight, enhances transparency, preserves innovation, avoids escalating costs and ensures widespread patient access for these essential medical services." AMP has long maintained that the best approach to ensuring the continued development and deployment of accurate and reliable LDT procedures —and the correct utilization, precise interpretation and proper application of molecular test results — is through clarifying the current CLIA regulations. AMP's legislative proposal builds on the existing oversight framework and offers test quality enhancements where appropriate. To read the full ruling, please visit the AMP website. ABOUT AMPThe Association for Molecular Pathology was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's more than 3,100 members practice various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions and oncology. Our members are pathologists, physicians, clinical laboratory directors, basic and translational scientists, technologists and trainees who practice in a variety of settings, including academic and community medical centers, government and industry. Through the efforts of its board of directors, committees, working groups and members, AMP is the primary resource for expertise, education and collaboration in one of the fastest-growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high-quality, appropriate testing. For more information, visit and follow AMP on X: @AMPath. MEDIA CONTACT:Andrew Nobleanoble@ View original content: SOURCE Association for Molecular Pathology Sign in to access your portfolio
