Latest news with #Cepheid
Yahoo
4 days ago
- Business
- Yahoo
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030.1 "Xpert® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578https:// About CepheidBased in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit IVD. In Vitro Diagnostic Medical Device. May not be available in all countries For Cepheid Media Inquiries:Darwa SOURCE Cepheid View original content to download multimedia: Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Cision Canada
4 days ago
- Business
- Cision Canada
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert ® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert ® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030. 1 "Xpert ® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert ® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert ® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578 About Cepheid Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit
Yahoo
4 days ago
- Business
- Yahoo
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030.1 "Xpert® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578https:// About CepheidBased in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit IVD. In Vitro Diagnostic Medical Device. May not be available in all countries For Cepheid Media Inquiries:Darwa SOURCE Cepheid View original content to download multimedia:
Yahoo
23-04-2025
- Business
- Yahoo
DHR Q1 Earnings: Bioprocessing Momentum and Tariff Strategy Drive Guidance Above Expectations
Diversified science and technology company Danaher (NYSE:DHR) announced better-than-expected revenue in Q1 CY2025, but sales were flat year on year at $5.74 billion. Guidance for next quarter's revenue was better than expected at $5.92 billion at the midpoint, 1.4% above analysts' estimates. Its non-GAAP profit of $1.88 per share was 14.4% above analysts' consensus estimates. Is now the time to buy DHR? Revenue: $5.74 billion vs analyst estimates of $5.59 billion (flat year on year, 2.7% beat) Adjusted EPS: $1.88 vs analyst estimates of $1.64 (14.4% beat) Adjusted EBITDA: $1.88 billion vs analyst estimates of $1.66 billion (32.7% margin, 13.3% beat) Revenue Guidance for Q2 CY2025 is $5.92 billion at the midpoint, above analyst estimates of $5.83 billion Adjusted EPS guidance for the full year is $7.68 at the midpoint, roughly in line with what analysts were expecting Operating Margin: 22.2%, in line with the same quarter last year Free Cash Flow Margin: 18.4%, down from 25% in the same quarter last year Organic Revenue fell 4% year on year, in line with the same quarter last year Market Capitalization: $137.5 billion Danaher's first quarter results were shaped by resilient bioprocessing demand and stronger-than-expected respiratory testing volumes at Cepheid. Management credited the company's recurring revenue streams and diversified end markets for stabilizing performance despite flat overall sales. CEO Rainer Blair highlighted ongoing investments in innovation and capacity, noting, 'The Danaher Business System continues to help us deliver productivity and share gains even as global markets remain dynamic.' Looking ahead, Danaher's guidance for the next quarter is supported by anticipated stability in end markets and continued operational discipline. The company expects to offset current tariff impacts by adjusting supply chains, implementing surcharges, and optimizing manufacturing locations. Blair emphasized that, 'We believe providing adjusted EPS guidance offers the best anchor point for assessing business performance,' reflecting a preference for cautious optimism given the uncertain macroeconomic environment. Danaher's leadership focused on the durability of its business model and execution of its long-term strategy, particularly as macroeconomic and geopolitical conditions remain fluid. The flat revenue trend was offset by notable outperformance in bioprocessing and higher-than-anticipated demand in diagnostics, while ongoing cost discipline and new product launches also shaped results. Bioprocessing Segment Momentum: The bioprocessing division delivered high-single digit growth, driven by strong commercial demand for consumables, particularly from large pharmaceutical and contract manufacturing customers. Order momentum remained positive for the seventh consecutive quarter, reinforcing management's confidence in the business's ability to deliver high-single digit growth in 2025 and beyond. Diagnostics Resilience and Product Launches: Cepheid's respiratory testing business exceeded expectations due to elevated illness levels, while new diagnostic products targeting cancer research (PD-L1, HER2 antibodies) and point-of-care molecular tests supported growth. Beckman Coulter's FDA clearance for a new chemistry analyzer expanded offerings for lower-volume laboratories. Life Sciences Mixed Performance: Life Sciences instruments saw stable demand in pharma, clinical, and applied markets, but softness in academic and government spending, especially in the United States, weighed on results. Management noted that government and academic revenue comprises a small portion of total sales, limiting overall impact. Tariff and Supply Chain Strategy: Danaher is proactively addressing tariff headwinds—estimated in the hundreds of millions of dollars—by regionalizing manufacturing, adjusting trade flows, and deploying surcharges. CFO Matt McGrew highlighted that these actions are designed to largely offset current tariff impacts. Disciplined Capital Allocation and M&A: The company maintains a preference for mergers and acquisitions as its primary use of capital but remains cautious given valuation uncertainty in the current environment. Management emphasized that a strong balance sheet positions Danaher to act when attractive opportunities arise. Danaher's outlook for the next quarter and full year centers on stable end market demand, with low-single digit revenue growth expected in Q2 and full-year adjusted EPS guidance set at $7.60 to $7.75. Bioprocessing and Consumables Growth: Management expects continued high-single digit growth in bioprocessing, underpinned by robust demand for consumables and a steady order pipeline. New capacity expansions are set to support both current and future customer needs. Tariff Mitigation Measures: The company's ability to offset tariff impacts through supply chain shifts, surcharges, and manufacturing changes is expected to help protect margins, though management cautioned that further escalation could require more aggressive actions. Life Sciences and Diagnostics Trends: While academic and government demand may remain soft, management anticipates stability in pharma and clinical segments, with new product launches and commercial execution in diagnostics providing incremental growth drivers. Michael Ryskin (Bank of America): Asked whether bioprocessing growth was more consumables or equipment-driven; management replied that consumables led growth, while equipment orders and funnels are improving but remain below historical levels. Tycho Peterson (Jefferies): Inquired about Danaher's ability to pass on price increases in the context of tariffs; CFO Matt McGrew explained that pricing is expected to be flat due to volume-based procurement in diagnostics, and surcharges for tariffs are not included in base pricing assumptions. Scott Davis (Melius Research): Sought color on China's long-term margin structure after procurement changes; CEO Rainer Blair said China remains an attractive diagnostics market, with pricing now in line with global averages. Doug Schenkel (Wolfe Research): Questioned the sustainability of margin guidance and sources of cushion; management confirmed some conservatism in guidance, with cost savings and FX tailwinds providing flexibility if macro conditions remain stable. Rachel Vatnsdal (J.P. Morgan): Asked about weakness in U.S. academic and government demand in Life Sciences; management noted this segment is a small revenue contributor and further softness is already factored into guidance. In the coming quarters, the StockStory team will be monitoring (1) sequential bioprocessing order growth and capacity utilization as indicators of continued demand, (2) the company's effectiveness in mitigating tariff-related cost pressures through operational actions, and (3) the trajectory of academic and government spending within Life Sciences. Progress on new product rollouts and any M&A activity will also serve as important signals for Danaher's execution against its strategic plans. Could DHR exceed our expectations? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. 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Yahoo
10-04-2025
- Business
- Yahoo
Oxford Nanopore inks infectious disease analysis pact with Cepheid
Oxford Nanopore Technologies has teamed up with Cepheid to speed up infectious disease genomic analysis, blocking out recent noise of acquisition vulnerability. The UK biotech, a former star of the London initial public offering (IPO) scene, said the strategic collaboration will help return genomic results of bacterial and fungal pathogens within hours, compared to days experienced with currently available technology. Shares in London-listed Nanopore opened 6% higher at market open on 10 April compared to market open on 9 April, the day the announcement was made. Nanopore and US-based Cepheid have already completed a proof-of-concept study that saw the two companies' technologies combined for infectious disease analysis. The new research uses only workflow now sees Cepheid's cartridge-based GeneXpert system used Oxford Nanopore's sequencing platform. Nanopore was spun out of Oxford University in 2005 with pioneering technology for sequencing nucleic acids on handheld devices. All the company's sequencing devices work by analysing long DNA or RNA fragments by monitoring an electrical current as the nucleic acids are passed through a protein nanopore. The collaboration with Cepheid – who sells the most widely installed polymerase chain reaction (PCR) diagnostic instrument in the world – aims to create a scalable, automated, and end-to-end solution for simplified nanopore sequencing workflows. The analysis is intended for use within a range of settings, including labs lacking in expertise that would not have done in-house sequencing. Profiling bacterial and fungal pathogens from culture isolates will be the first port of call for the partnership, with analysis directly from positive blood cultures also in the pipeline. There is also a potential expansion into further infectious disease use cases, such as cancer and human genetics, and eventually regulatory approved clinical diagnostics. "This collaboration represents an important step forward in delivering new and improved workflow options to better understand infectious diseases," said Dr. Gordon Sanghera, CEO of Oxford Nanopore Technologies. "By partnering to integrate our richer data, rapid insights, and accessible and affordable sequencing technology with Cepheid's GeneXpert architecture, we are establishing a workflow foundation that is positioned for future expansion into scaled routine clinical use." The partnership with Cepheid comes nearly a month after Dr. Sanghera admitted to the Financial Times that the company had become a takeover target. Nanopore went public in 2021 on the back of surging sales for its sequencing devices in the Covid-19 pandemic. At the time, it was seen as a major coup for the London stock market, with companies generally preferring to tap the more lucrative exchanges on Wall Street. However, sales dried up for the company as demand for pandemic-related products waned. Despite shares having fallen 85% from a 2021 speak, Nanopore still boasts a market cap just north of £1bn. Other companies partnered with Nanopore include France-based bioMérieux, a biotech that increased its stake in the UK company via a $85m investment in late 2023. Like Cepheid, bioMérieux is working with Nanopore in infectious disease analysis – specifically developing a test for determining the antibiotic resistance of tuberculosis. "Oxford Nanopore inks infectious disease analysis pact with Cepheid" 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
