Latest news with #Diagnostic
Business Wire
29-05-2025
- Business
- Business Wire
Diagnostics.ai Launches Industry's First CE-IVDR Certified Transparent AI Platform for Molecular Diagnostics as Regulatory Deadlines take Effect
LONDON--(BUSINESS WIRE)-- Revolutionary Platform Sets New Benchmark for Transparency and Compliance in Diagnostic AI First-of-its-kind platform for molecular diagnostics shows exactly how AI-generated PCR result analyses are achieved - delivering transparency, trust, and CE-IVDR compliance. As the May 26th CE-IVDR compliance deadline comes into effect, launches the industry's first fully-transparent machine learning platform for clinical real-time PCR diagnostics – demonstrating exactly how each result was achieved, a first for molecular-testing machine learning. The technology is backed by over 15 years of experience and millions of successfully processed samples with >99.9% proven accuracy. The CE-IVDR Strategic Advantage Platform is response to the new wave of stringent EU regulations under the In Vitro Diagnostic Medical Devices Regulation (IVDR), which demand heightened standards for diagnostic accuracy, reproducibility, and algorithm transparency. 'While most diagnostic algorithms remain an impenetrable 'black box,' the API was engineered with transparency included from the ground up,' said Aron Cohen, Chief Executive Officer of 'Our platform delivers transparency and traceability that meet and support the highest standards set by CE-IVDR, making the AI decision-making process visible, understandable, and traceable.' Key Innovations of the Transparent AI Architecture platform is built around a pioneering 'model-aware' architecture, enabling laboratories to understand the suggestions that the AI makes. Highlighted Benefits: Transparent Result Attribution Directly shows how and why a result was achieved, eliminating reliance on post-hoc interpretations. Real-Time Model Monitoring Allows laboratories to track model performance and detect drift in real time – meeting IVDR Article 72 requirements. Per-Test Algorithm Accountability Easy to understand per test reports, ensuring comprehensive auditability. Clinician-Ready Explanation Generation Provides laboratory professionals and clinicians with clear, auditable explanations of diagnostic outcomes, supporting informed clinical communication. 'Our platform bridges the gap between compliance necessity and clinical confidence,' said Dr. Brian Glenville MD, Chairman of 'Laboratory directors can now explain to regulators, clinicians, and patients exactly how each diagnostic result was determined, creating a new level of trust in molecular diagnostics.' Now Available Across Europe The CE-IVDR Strategic Advantage Platform - including the CE-IVDR and MHRA registered AI API, as well as technical, regulatory and implementation support - is now available across Europe for both clinical laboratories and diagnostic manufacturers, empowering them to meet and exceed regulatory obligations while achieving deeper confidence in diagnostic results. Already in successful use in the U.S., U.K., and other countries, is trusted by leading laboratories for its reliable and transparent diagnostic performance. About is an established leader in AI-powered PCR analysis with over 15 years of experience serving clinical laboratories worldwide. The company has processed millions of samples with documented >99.9% accuracy and maintains full CE-IVDR and MHRA compliance. transparent machine learning platform transforms laboratory efficiency while enabling regulatory compliance.
New Indian Express
25-05-2025
- Health
- New Indian Express
Karnataka records nearly 100 Covid-19 cases
BENGALURU: With nine new COVID-19 cases reported on Sunday, Karnataka's total Covid cases have nearly marked a century. While there were no deaths, the state in the last 24 hours reported a positivity rate of 8.65%. Currently, of the total 47 active cases statewide, 46 are isolating at home and one is admitted to a private hospital. In the last 24 hours, 104 tests were done, including RT-PCR and rapid antigen tests. To keep a closer watch on the virus, the State Health Department said it will increase daily RT-PCR testing to 150-200 across Karnataka, following recommendations from the Covid Technical Advisory Committee to step up COVID-19 surveillance. From Sunday, Karnataka also began testing for Severe Acute Respiratory Infection(SARI) cases. Moreover, individuals in high-risk groups, such as the elderly, children, and pregnant women, with symptoms of Influenza-like Illness (ILI) will also be tested at both government and private hospitals. As the number of covid cases remains relatively low, covid testing is concentrated at centres equipped with Viral Research and Diagnostic Laboratories (VRDL). In Bengaluru, key institutions such as NIMHANS, Bangalore Medical College and Research Institute (BMCRI) and National Institute of Virology (NIV) are among the 10 centres designated as Covid testing centres. Health Minister Dinesh Gundu Rao clarified that while the overall situation is not alarming, precautionary measures are being intensified to ensure the state remains prepared. 'The current state does not require panic or restrictions. Officials and experts are monitoring continuously. Any further decisions will be taken in consultation with the central government,' he said.
Associated Press
08-05-2025
- Business
- Associated Press
Stevanato Group Reports Revenue of €256.6 Million for the First Quarter of 2025
PIOMBINO DESE, Italy--(BUSINESS WIRE)--May 8, 2025-- Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the first quarter of 2025. First Quarter 2025 Highlights (comparisons to prior-year period) First Quarter 2025 Results For the first quarter of 2025, revenue increased 9% (8% on a constant currency basis) compared with the same period last year, to €256.6 million, driven by an 11% increase in the Company's Biopharmaceutical and Diagnostic Solutions (BDS) Segment, which offset the expected 4% decline in the Engineering Segment. Revenue from high-value solutions increased to €110.3 million and represented 43% of total revenue for the first quarter of 2025, driven by strong demand in high-value syringes, increased capacity in Latina and Fishers, and a partial recovery in EZ-fill ® vials, as the effects of destocking gradually subside. Gross profit margin for the first quarter of 2025 increased by 80 basis points to 27.2%, compared with the same period last year. Margin expansion was driven by strong performance in the BDS Segment from the ongoing expected improvements at the Latina and Fishers facilities as volumes, utilization, and revenue begin to scale, and from an increased mix of high-value solutions, including a modest recovery in EZ-fil l® vials. This was partially offset by lower gross profit from the Engineering Segment resulting from an unfavorable project mix. For the first quarter of 2025, operating profit margin increased to 13.5%, and adjusted operating profit margin increased to 14.3%, driven by an increase in gross profit and benefits from cost management initiatives that were launched last year. Franco Stevanato, Chairman and Chief Executive Officer, stated, 'The strong performance in the Biopharmaceutical and Diagnostic Solutions Segment drove top-line growth and margin expansion in the first quarter. Strong end-market demand continues to support the growth in high-value solutions, which reached 43% of revenue in the quarter. Our investments in capacity are crucial to satisfy the market needs as we aim to further capitalize on growing patient demand for biologics. While the Engineering Segment performed largely in line with our expectations, we remain focused on completing the legacy projects in Denmark. We have taken decisive actions, and we are making meaningful operational progress as we advance our business optimization plan.' Biopharmaceutical and Diagnostic Solutions (BDS) Segment Revenue grew 11% (11% on a constant currency basis) to €220.8 million for the first quarter of 2025, compared with the same period last year, driven primarily by growth in high-value syringes, and, to a lesser extent, other product categories. Revenue from high-value solutions increased to 50% of BDS Segment revenue in the first quarter, driven by strong customer demand, increasing capacity in Latina and Fishers, and a partial recovery in EZ-fill ® vials. For the first quarter of 2025, gross profit margin increased 420 basis points to 31.3%, driven by the aforementioned improvements from the new facilities in Latina and Fishers, as volumes and revenue begin to scale, and a favorable mix of high-value solutions. Engineering Segment Revenue from the Engineering Segment decreased 4% to €35.7 million for the first quarter of 2025, driven by lower revenue in glass conversion and visual inspection manufacturing lines, which was partially offset by growth in assembly and packaging lines, and after-sales services. For the first quarter of 2025, margins were unfavorably impacted by the mix of projects in the portfolio, as the Company continues to prioritize the completion of its legacy projects in Denmark. This led to gross profit margin of 10.7% and operating profit margin of 4.7%. The Company is focused on executing its business optimization plan and still expects to complete all of the legacy projects in 2025, with the majority expected to be completed by mid-2025. Balance Sheet and Cash Flow At March 31, 2025, the Company had cash and cash equivalents of €90.7 million and net debt of €300.2 million. The Company believes that it has available liquidity to fund its strategic priorities over the next twelve months through a combination of cash on hand, available credit lines, cash generated from operations, and the ability to access additional financing. Capital expenditures totaled €69.7 million for the first quarter of 2025, as the Company continues to ramp-up capacity in response to customer demand for high-value solutions in Fishers, Indiana and Latina, Italy. In the first quarter of 2025, cash flow from operating activities was €99.8 million. Cash flow used for the purchase of property, plant, and equipment, and intangible assets totaled €71.8 million. The combination of increased cash flow from operations and lower capex helped drive a significant year-over-year improvement in free cash flow, and in the first quarter of 2025, the Company generated free cash flow of €29.7 million. 2025 Guidance The Company is maintaining its fiscal 2025 revenue guidance, and updating its fiscal 2025 adjusted EBITDA and adjusted diluted earnings per share guidance to include the estimated impact of recently announced tariffs. Before the impact of tariffs, the Company's guidance remains consistent with its prior guidance issued in March, of revenue in the range of €1.160 billion to €1.190 billion, adjusted EBITDA in the range of €293 million to €306.3 million, and adjusted diluted earnings per share in the range of €0.51 to €0.55. The Company estimates a tariff-related impact of approximately €4.5 million on operating profit, or approximately one cent of adjusted diluted earnings per share in fiscal 2025, which considers the effects of rounding. The estimated tariff impact is based on information available on the current tariff programs implemented as of May 2, 2025. The Company's updated guidance assumes the current tariffs in place today, including a 10% tariff on European goods destined for the U.S., and the absorption of price increases from suppliers. The Company has implemented mitigation strategies aimed to further reduce its exposure in 2025, and these efforts will continue. The ongoing ramp-up in Fishers, Indiana, is expected to help mitigate potential impacts in the future. As a result, the Company continues to expect revenue in the range of €1,160 million to €1,190 million. The Company now expects Franco Stevanato concluded, 'We continue to deliver organic growth driven by solid demand for high-value solutions, and we exited the first quarter with positive momentum in the BDS Segment. We expect continued improvements in Latina and Fishers as these facilities scale and mature, and we see ongoing stabilization in vial demand, as destocking gradually fades. The team is laser focused on executing our key priorities and achieving our long-term objectives. We believe that the fundamentals of our business are strong, as we operate in growing end markets with favorable secular tailwinds. We remain committed to returning the business to double-digit growth, expanding margins, and building long-term shareholder value.' Conference call: The Company will host a conference call and webcast at 8:30 a.m. (ET) on Thursday, May 8, 2025, to discuss financial results. During the call, management will refer to a slide presentation which will be available on the morning of the call on the 'Financial Results' page under the Investor Relations section of the Company's website. Pre-registration: Participants who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. We encourage participants to pre-register for the conference call using the following link: Pre-registration for STVN Q1 2025 earnings webcast. Webcast: A live, listen-only webcast of the call will be available at the following link: STVN Q1 2025 webcast. Dial in: Those who are unable to pre-register may dial in by calling: Questions during the call: Participants who wish to ask questions during the call should use the HD webphone link: STVN Q1 2025 Link for Questions. Replay: The webcast will be archived for three months on the Company's Investor Relations section of its website. Forward-Looking Statements This press release may include forward-looking statements. The words 'begin,' 'ongoing,' 'continues,' 'growth,' 'aim,' 'growing,' 'assumes,' 'are making,' 'advance,' 'potential,' 'expects,' 'expected,' 'believes,' 'continue,' 'expect,' 'continued,' 'see,' 'gradually,' 'achieving,' 'remain,' 'believe,' 'expanding,' 'building,' and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the Company's future financial performance, including revenue, operating expenses and ability to maintain profitability and operational and commercial capabilities; the Company's expectations regarding the development of the industry and the competitive environment in which it operates; the expansion of the Company's plants and sites, and our expectations related to our capacity expansion; the global supply chain and the Company's committed orders; customer demand and customers' ability to destock higher inventories accumulated during the COVID-19 pandemic; the success of the Company's initiatives to optimize the industrial footprint, harmonize processes and enhance supply chain and logistics strategies; the Company's geographical and industrial footprint; and the Company's goals, strategies and investment plans. The forward-looking statements in this press release are based on numerous assumptions regarding the Company's present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as conditions in the U. S. capital markets, negative global economic conditions, inflation, trade war and global tariff policies, the impact of the conflict between Russia and the Ukraine, the evolving events in Israel and Gaza, supply chain and logistical challenges and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the geopolitical, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. For a description of the risks that could cause the Company's future results to differ from those expressed in any such forward looking statements, refer to the risk factors discussed in our most recent annual report on Form 20-F filed and our most recent filings with the . Securities and Exchange Commission. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements. Non-GAAP Financial Information This press release contains non-GAAP financial measures. Please refer to the tables included in this press release for a reconciliation of non-GAAP financial measures. Management monitors and evaluates our operating and financial performance using several non-GAAP financial measures, including Constant Currency Revenue, EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin, Adjusted Operating Profit, Adjusted Operating Profit Margin, Adjusted Income Taxes, Adjusted Net Profit, Adjusted Diluted EPS, CAPEX, Free Cash Flow, Net Cash/(Debt), and Capital Employed. The Company believes that these non-GAAP financial measures provide useful and relevant information regarding its performance and improve its ability to assess our financial condition. While similar measures are widely used in the industry in which the Company operates, the financial measures it uses may not be comparable to other similarly titled measures used by other companies, nor are they intended to be substitutes for measures of financial performance or financial position as prepared in accordance with IFRS. About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes, and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group's core capabilities in scientific research and development, its commitment to technical innovation, and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: Non GAAP Financial Information This press release contains non-GAAP financial measures. Please refer to 'Non-GAAP Financial Information' on page 4 and the tables included in this press release for a reconciliation of non-GAAP financial measures. View source version on CONTACT: Media Stevanato Group [email protected] Relations Lisa Miles [email protected] KEYWORD: ITALY EUROPE INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE RESEARCH PHARMACEUTICAL HEALTH PACKAGING HEALTH TECHNOLOGY MANUFACTURING SOURCE: Stevanato Group S.p.A. Copyright Business Wire 2025. PUB: 05/08/2025 06:37 AM/DISC: 05/08/2025 06:36 AM
Business Upturn
23-04-2025
- Business
- Business Upturn
Lupin Diagnostics achieves 100% NABL accreditation for all greenfield labs
By Aditya Bhagchandani Published on April 23, 2025, 10:18 IST Lupin Diagnostics Limited, a wholly owned subsidiary of global pharmaceutical company Lupin, has announced that it has secured 100% NABL accreditation across all its greenfield laboratories in India. This makes Lupin Diagnostics one of the few diagnostic chains in the country to have all its facilities accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL). In a statement released on April 23, 2025, Ravindra Kumar, CEO of Lupin Diagnostics, said, 'This accreditation is a testament to the team's dedication to patient care and our mission to promote healthier lives. The 27 greenfield labs across the country ensure timely and accurate reporting. Our goal is to empower doctors and patients with evidence-based diagnostics.' The recognition reflects Lupin Diagnostics' consistent focus on quality, operational efficiency, and patient-centric services. The company has been recognized with several national awards, including the 'Patient-Centric Diagnostic Laboratories Company of the Year' at the IHW 3rd Patients First Award 2024, and 'Pathology Lab of the Year' at the ET Healthcare Awards 2022 and 2024. Founded in December 2021, Lupin Diagnostics started with a 45,000 sq. ft. National Reference Laboratory in Navi Mumbai and has since grown its footprint across West, South, East, and Central India. Its labs provide over 3,000 types of diagnostic tests, including molecular diagnostics, microbiology, cytology, immunology, and biochemistry. This milestone marks a significant step in Lupin's broader vision of enhancing healthcare infrastructure in India and promoting accurate, reliable, and accessible diagnostics to every corner of the country. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Fox News
06-02-2025
- Politics
- Fox News
Morning Glory: Trump Derangement Syndrome was real. So is 'Long TDS'
COVID-19 killed at least 7 million people worldwide and more than a million in the United States. The "official" worldwide deaths number is very low because China and other totalitarian states didn't report accurately (just as China concealed the source of the virus) and poor countries had no infrastructure for counting and reporting. But COVID was the deadliest pandemic in the world since the Spanish flu that appeared at the end of World War I. "Long COVID" impacted hundreds of thousands of Americans and still does though many have recovered or are recovering completely. It's a debilitating suite of symptoms that follow in the wake of the virus and while recovery has occurred for many, and is occurring for more, getting through "long COVID" often only occurs after years of rest and treatment. There are parallels in the media, both legacy and new media, to COVID and "Long COVID," parallels that are useful to spell out. The parallels present life and death issues for the news platforms involved and the careers of those afflicted. PRO-TRUMP INFLUENCER WILL TAKE LEGAL ACTION AGAINST NEW YORK MAGAZINE OVER 'DESPICABLE' COVER STORY "Trump Derangement Syndrome" was real and on open display before and most certainly after President Donald Trump's shock win in 2016, which was certainly the biggest upset in modern American political history. That shock destabilized a lot of news organizations and many "reporters" and analysts. They could not recover their balance, could not report objectively on the good things that Trump accomplished in his first term. They focused solely and sometimes obsessively on false narratives about him or on his faults and mistakes, many of which were also utterly false like "Russia, Russia, Russia." "Trump hatred" combined in some places with "Fox News hatred/envy" to destroy the credibility of many people and platforms. Audience shares plummeted. If those individuals haven't outright lost their jobs, they and their platforms have lost some, if not most of their audience. TDS was a killer of credibility. (Diagnostic tool: If you couldn't write or produce a detailed story about the greatness of the Abraham Accords then you definitely had TDS.) Most people and platforms in the news business recovered some or most of their balance during the long, slow descent of the Biden administration into paralysis and confusion, a decline in direction and achievement that mirrored Biden's physical decline. When Trump won overwhelmingly in November and did it so decisively that only ideologues could not see the significance of the vote, many with "TDS" forced themselves "on to the wagon" and abandoned reflexive "Trump hatred." As with all 12-step programs, first they had to admit they had a problem. Many did. Bravo. Some haven't and their business model is simply to settle for super-serving the hard left or the irreconcilable right in the country. Fine. CLICK HERE FOR MORE FOX NEWS OPINION BUT … there are now appearing in the third week of the second Trump presidency signs that "long TDS" is real and potentially widespread. Many journalists and analysts have "fallen off the wagon" concerning their pledge — internal and sometimes public — to cover Trump objectively, and have reverted to reflexive "Orange Man Bad." It seeps into many posts on X, many stories from legacy media, many podcasts across the ideological spectrum. In a nutshell, "long TDS" disables a reporter or analyst from even seeing the possibility of method and goals that Trump routinely deploys. They dislike him so much for various reasons —often aesthetic, sometimes policy-driven, often because they are partisans who won't admit that fact to themselves or their audience — that they use the language of psychiatry to describe political actions: Trump is "crazy," Trump is a "lunatic," Trump is wildly undisciplined, always acting as a narcissist, always impulsive and caught in policy contradictions. They never entertain, even if only to dismiss, that he has plans and he's executing them. I often disagree with the president (e.g. most recently on removing security details from targets of Iranian lethal retribution in our own country — a potential assassination or attack that could kill or injure past public servants and which would deal a terrible blow to his presidency.) Even more recently I was very wary of tariffs on Canada, but I suspect a non-economic motive there and with Mexico involving messaging to everyone in the world intending to cross our borders illegally or to continue their fentanyl distribution. Disagree with the effectiveness or the result but to not even entertain the idea that there's a plan and he executed on it is a sure sign of "long TDS." "Trump Derangement Syndrome" was real and on open display before and most certainly after President Donald Trump's shock win in 2016, which was certainly the biggest upset in modern American political history. CLICK HERE TO GET THE FOX NEWS APP Smart people have to self-diagnosis about whether they have "long TDS." It is obvious to those of us who are openly partisan but also ready to criticize Trump as we did aspects of the George W. Bush presidency (remember the "ports deal?") or the campaign of then-former Governor Romney. A reporter or analyst who cannot stay calm and report fairly both the good and the bad as they see it, and crucially do it without raising their voices or rejecting out of hand contrary arguments needs to revisit their symptoms. Everybody else hears it and sees it, whether on a legacy network or a brand-new podcast. You cannot "win" audience back or find new audience if all they hear is the sound that accompanied the wreckage or legacy media in the last 10 years. Hugh Hewitt is host of "The Hugh Hewitt Show," heard weekday mornings 6am to 9am ET on the Salem Radio Network, and simulcast on Salem News Channel. Hugh wakes up America on over 400 affiliates nationwide, and on all the streaming platforms where SNC can be seen. He is a frequent guest on the Fox News Channel's news roundtable hosted by Bret Baier weekdays at 6pm ET. A son of Ohio and a graduate of Harvard College and the University of Michigan Law School, Hewitt has been a Professor of Law at Chapman University's Fowler School of Law since 1996 where he teaches Constitutional Law. Hewitt launched his eponymous radio show from Los Angeles in 1990. Hewitt has frequently appeared on every major national news television network, hosted television shows for PBS and MSNBC, written for every major American paper, has authored a dozen books and moderated a score of Republican candidate debates, most recently the November 2023 Republican presidential debate in Miami and four Republican presidential debates in the 2015-16 cycle. Hewitt focuses his radio show and his column on the Constitution, national security, American politics and the Cleveland Browns and Guardians. Hewitt has interviewed tens of thousands of guests from Democrats Hillary Clinton and John Kerry to Republican Presidents George W. Bush and Donald Trump over his 40 years in broadcast, and this column previews the lead story that will drive his radio/ TV show today.
