CEPHEID

First diagnostic company to pledge support towards collaborative efforts for real-world solutions to a global problem. SUNNYVALE, Calif., Sept. 24, 2024 /PRNewswire/ -- Cepheid announced today an important partnership with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust and Imperial College London to combat antimicrobial resistance. The Fleming Initiative and Cepheid will introduce the partnership at an event in New York aligned with the United Nations General Assembly High Level Meeting about AMR1. The Fleming Initiative brings together research scientists, policymakers, clinicians, behavioral experts, public and commercial partners to provide the networks, expertise and skills to provide equitable solutions to AMR at the global scale. "Almost everyone who has visited a healthcare provider for an undiagnosed infection has taken antibiotics as a preventative measure at one time in our lives. Too often, we are given broad spectrum antibiotics for viral infections or allergic reactions instead of as a treatment for a bacterial infection. That's how antimicrobial resistance develops," said Vitor Rocha, President of Cepheid. "Accurate diagnostics are at the frontline of the battle to eliminate preventative antibiotic use. Every one of us can help reduce unnecessary antibiotic use by requesting an accurate diagnostic test to identify the source of an infection before we begin a course of antibiotics." The Initiative will draw on diverse expertise and public involvement to tackle antimicrobial resistance from all angles. The partners will work together to catalyze worldwide action in the fight against AMR where poverty, climate change, and health inequality exacerbate the issues caused by drug-resistant infections. "At the Fleming Initiative we aim to unlock powerful new ideas to drive significant change in the fight against AMR. This requires collective innovation across industries, from practitioners to policy-makers and the public," said Professor the Lord Darzi of Denham, Executive Chair of the Fleming Initiative. "I am delighted to welcome Cepheid as our first diagnostics partner. Currently 20% of antibiotic prescriptions given in primary care lack an appropriate diagnosis. We have to do better. Cepheid's expertise will be essential to our efforts to ensure antibiotics work for generations to come." AMR is widely recognized by the World Health Organization as one of the top ten public health threats in the world. A study published this month in the Lancet2 found that resistance to antibiotics has led to over one million deaths each year since 1990. The study predicts increasing rates of drug-resistant infections will cause annual deaths to rise from 1.14 million in 2021 to 1.91 million in 2050 and forecasts that without further policy interventions, global deaths will reach 39 million between 2025 and 2050—the equivalent of three deaths per minute. Cepheid's significant pledge to the Fleming Initiative will be used for collaborative scientific and clinical research, with a focus on strengthening and expanding the use of in vitro diagnostics to support antimicrobial stewardship programs to enable responsible antibiotic use and control the rise of resistant infections. The collaboration will focus initially on the most critical areas of AMR: Encourage active screening for carbapenemase-producing Enterobacteriaceae (CPE) for earlier detection of critical infections and colonization Implementation of community-based acute respiratory infection (ARI) testing and care pathways to provide decentralized diagnostic and treatment pathways Accelerate a precision medicine approach for sepsis to identify and treat patients with a particular sepsis response state About Antimicrobial Resistance (AMR) AMR occurs when microbes including bacteria, viruses, fungi and parasites change over time and no longer respond to the drugs and treatments society relies on to kill them and prevent disease. If measures are not urgently implemented to combat AMR, the consequences will be far reaching. Uncomplicated infections and minor injuries could once again become life-threatening. AMR kills over one million people around the world each year3 and is a growing challenge in treating leading infectious disease killers such as tuberculosis, Escherichia coli (E. coli), and Methicillin-resistant Staphylococcus aureus (MRSA). It has been caused in part by the widespread misuse and overuse of antibiotics and other antimicrobial medicines, in humans and livestock, which has led to the global spread of drug-resistant microbes. To effectively tackle AMR, global awareness and behavior change is needed. About Cepheid Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company's solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit . Fleming Initiative The Fleming Initiative has a strong focus on diagnostics so that the right antimicrobial drugs are given to those who need them, as well as focusing on education and public engagement to support behavioural change to reduce drug-resistant infections. Launched through a partnership between Imperial College Healthcare NHS Trust and Imperial College London, the Fleming Centre will combine cutting edge research, public engagement, and work with policymakers to drive a global change. Earlier this year global biopharma company GSK became the first founding partner of the Initiative, with a pledge of £45m. The international work of the Initiative will be carried out by establishing a global network of centres in strategic locations around the world that will find, test, and scale solutions to AMR. Taking an enabling and scaling role, the first Fleming Centre will be based at St Mary's Hospital in London - at the site of the discovery of penicillin by Alexander Fleming in 1928 - and will form a key part of the Imperial's WestTech Corridor and Paddington Life Sciences. As Patron of the appeal to create the Fleming Initiative, His Royal Highness Prince William, the Prince of Wales, is supporting efforts over the next four years to develop this global HQ for the Fleming Initiative programmes. About Imperial College London Imperial College London is a global top ten university with a world-class reputation. Imperial's 22,000 students and 8,000 staff are working to solve the biggest challenges in science, medicine, engineering and business. Imperial ranks sixth in the 2024 QS World University Rankings and eighth in the 2024 Times Higher Education World University Rankings. The 2021 Research Excellence Framework (REF) found that it has a greater proportion of world-leading research than any other UK university. It also received a Gold Award in the 2023 Teaching Excellence Framework (TEF). Imperial was named University of the Year in the Daily Mail University Guide 2024, University of the Year for Graduate Employment in The Times and Sunday Times Good University Guide 2024, and awarded a Queen's Anniversary Prize for its COVID-19 response. For more information, visit . 1UN General Assembly High-Level Meeting on antimicrobial resistance 2024 2Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050 (Accessed Sept. 2024) Naghavi, Mohsen et al. The Lancet, Volume 0, Issue 0 3World Health Organization: Antimicrobial resistance (Accessed Sept. 2024) For Cepheid Media Inquiries: Darwa Peterson [email protected] SOURCE Cepheid WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The layoffs impact approximately 13% of the molecular diagnostics company's 4,800 employees. Testmaker Cepheid plans to eliminate 626 staff positions at its Sunnyvale, California headquarters by September 27, according to a regulatory filing.The bulk of the layoffs impact manufacturing associates and staff in material handling, according to a Worker Adjustment and Retraining Notification (WARN) report filed with the state of California on July 31. The cuts also impact some senior management roles and engineering positions.The layoffs impact approximately 13% of the molecular diagnostics company's 4,800 employees.Part of the Danaher Corporation, Cepheid develops and manufactures molecular systems and tests. The company developed the GeneXpert system, a modular and scalable system that provides all the lab processes needed for diagnostics through a small cartridge. Lab technicians can feed the cartridge into a machine to read the results. Last month, the FDA greenlit Cepheid's first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs.The company received an FDA de novo clearance and a laboratory waiver for its Xpert HCV diagnostic, which runs on its GeneXpert Xpress tabletop PCR system—allowing it to be used not only in doctor’s offices, emergency rooms and urgent care clinics but also at substance use disorder treatment centers, syringe programs and correctional facilities.Cepheid also plans to lay off 11 employees at its East Bay Logistic Center in Fremont.Cepheid will be offering all impacted associates on-site outplacement services provided by a third-party vendor, free of charge, the company said in the WARN report.

Clinical Research Efforts Supported by NIH-FDA's ITAP Program and Facilitate De Novo Authorization CARLSBAD, Calif., July 10, 2024 /PRNewswire/ -- DCN Dx, a global leader in IVD CDMO and CRO services, is proud to amplify the news that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization with Clinical Laboratory Improvement Amendments (CLIA) Waiver for the Cepheid Xpert HCV test. The press release announcing the news is available on the FDA's website here. This groundbreaking test, supported by DCN Dx's clinical research, is the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV), designed to enable HCV diagnosis and initiation of treatment in a single visit. This innovation simplifies the testing process and provides results within one hour, reducing the need for multiple appointments and increasing the likelihood of patients receiving timely treatment. The Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) RADx Tech program in collaboration with the FDA, played a crucial role in the evaluation and authorization of the Xpert HCV test. NIH-FDA ITAP program was launched to accelerate test evaluation to support the FDA's regulatory review and the availability of high-quality, accurate, and reliable diagnostic tests to the public. DCN Dx's clinical research services team worked closely with NIH-FDA ITAP, Cepheid, and the many participating clinical sites to ensure timely enrollment, testing, and documentation that established the clinical performance for this urgently needed product. "We are pleased to receive FDA authorization for the Xpert HCV test," said Scott Campbell, PhD, Senior Vice President Quality, Regulatory, and Clinical Affairs at Cepheid. "DCN Dx's clinical research and the NIH-FDA ITAP program's support were crucial in achieving this milestone, demonstrating the value of effective collaboration in public health initiatives." "Congratulations to Cepheid on this remarkable achievement," said Charlie Mamrak, CEO of DCN Dx. "We are honored to have supported the clinical research that contributed to the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. This test will have a profound impact on public health by streamlining HCV diagnosis and treatment." "Our team is dedicated to advancing diagnostic solutions that improve patient care," said Emily Friedland, VP of Clinical Research at DCN Dx. "We are proud to have played a role in bringing this innovative test to market." About DCN Dx DCN Dx, based in Carlsbad, California, is a global leader in IVD CDMO and CRO services. Our multidisciplinary CDMO excels in creating tailored assay systems, consumables, and instruments for point-of-use applications, with particular expertise in lateral flow assays. Our clinical research services group can plan, execute, and oversee clinical trials for any IVD device, including clinical operations, data management, and biostatistics. To learn more about how we can support your diagnostic needs, visit dcndx.com. For more information contact: Mitzi Rettinger Chief Revenue Officer, DCN Dx Main: (760) 804-3886 Mobile: (512) 431-5836 [email protected] SOURCE DCN Dx