GRAIL Reports Fourth Quarter and Full Year 2025 Financial Results [Accessibility Statement] Skip NavigationSold More Than 185,000 Galleri® Tests in 2025, Growing U.S. Galleri Revenue 26% Year-Over- Year to $136.8 MillionCompleted Galleri PMA Submission to FDAShared Topline Results from the NHS- Galleri TrialCompleted Analysis of the Full 35k Participant PATHFINDER 2 StudyStrong Financial Position with Cash into 2030MENLO PARK, Calif., Feb. 19, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare co ...

Core Insights - Intelligent Bio Solutions Inc. reported a revenue of over $2 million for the first half of fiscal 2026, reflecting a 36% year-over-year increase [1][8] - Reader sales more than doubled, increasing by 104% year-over-year in the second quarter, indicating strong market demand for the company's non-invasive drug testing technology [3][7] - Gross profit margins improved to 49%, up 10% from the previous year, showcasing enhanced operational efficiency [1][8] Financial Performance - For the three months ended December 31, 2025, total revenue reached $896,774, a 48% increase year-over-year, driven by significant growth in reader and cartridge sales [5][7] - Reader sales for the second quarter amounted to $246,519, up 104% from $120,787 in the same period last year, while cartridge sales grew by 33% to $516,754 [5][7] - For the six months ended December 31, 2025, total revenue was $2,008,571, with reader sales increasing by 50% to $533,432 and cartridge sales growing by 38% to $1.2 million [8][17] Operational Highlights - The company added 49 new customer accounts in the first half of fiscal 2026, indicating sustained customer adoption across international markets [8] - A new manufacturing partnership was announced, expected to enhance gross profit margins and drive cost efficiencies [6][12] - The company is progressing towards FDA 510(k) submission, aiming for entry into the U.S. market, which is projected to be a multi-billion-dollar opportunity [5][12] Strategic Initiatives - The company formed a strategic alliance with Vlepis Pty Ltd to enter the consumer health monitoring market, broadening revenue opportunities beyond commercial screening [12] - A major contract was secured with a leading industrial service provider, further expanding the company's presence in safety-critical sectors [12] - The company is focused on maintaining financial discipline while investing in commercial expansion linked to operational results [3][12]

Core Insights - Labcorp has launched the Elecsys® pTau-181 test, the first FDA-cleared blood test for Alzheimer's disease assessment in primary care settings, now available nationwide for patients aged 55 and older experiencing cognitive decline [1] Group 1: Product Launch and Features - The Elecsys pTau-181 test aids clinicians in ruling out Alzheimer's disease by identifying patients unlikely to have amyloid pathology, allowing for timely evaluation of other cognitive decline causes [1] - The test offers a 97.9% negative predictive value, enhancing clinicians' confidence in ruling out Alzheimer's pathology in symptomatic patients [1] - Developed by Roche Diagnostics, the test was cleared by the FDA in 2025 and is performed via a simple blood draw, making it accessible in doctor's offices or Labcorp's over 2,200 patient service centers nationwide [1] Group 2: Market Context and Commitment - With an estimated 7.2 million Americans living with Alzheimer's disease, Labcorp is focused on expanding access to blood-based biomarkers for earlier assessment and diagnosis [1] - The launch of the Elecsys pTau-181 test strengthens Labcorp's portfolio of blood-based biomarker tests for Alzheimer's disease and other forms of dementia [1] - Labcorp has supported over 90 Alzheimer's disease protocols across more than 45 countries in the last five years, showcasing its deep expertise in Alzheimer's biomarkers and commitment to innovative testing [1]

Core Insights - Intelligent Bio Solutions Inc. anticipates record revenue growth for fiscal Q2 2026, driven by an expanding customer base and strong performance across all product categories [1][2] - Reader sales are expected to more than double year-over-year, with a growth rate exceeding 100% in fiscal Q2 [1][2] - The company emphasizes a razor-razorblade business model, where each reader placement fosters long-term relationships that generate recurring cartridge revenue [2] Revenue Expectations - Total revenue for fiscal Q2 2026 is projected to be approximately $2.01 million, reflecting a 36% year-over-year increase [5] - Cartridge sales are expected to rise by approximately 38% year-over-year, while reader sales are anticipated to increase by about 50% year-over-year [5] - Other sales, including accessories and training, are expected to grow by approximately 10% year-over-year [5] Business Model and Strategy - The anticipated 33% growth in cartridge sales illustrates the effectiveness of the company's business model, highlighting new customer adoption and ongoing demand for consumables [2] - The company is confident in its commercial strategy and aims to capture greater market share as its installed reader base expands [2] - The Intelligent Fingerprinting Drug Screening System is positioned to revolutionize portable testing through rapid, non-invasive methods, targeting various industries such as construction and logistics [3]

Core Insights - Intelligent Bio Solutions Inc. has initiated a clinical study program to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, aimed at detecting the opiate codeine [1][5] - The U.S. drug screening market presents a significant commercial opportunity, generating several billion dollars annually across various sectors [4] Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, with a focus on fingerprint-based drug screening technology [6] - The Intelligent Fingerprinting Drug Screening System is designed to be hygienic, cost-effective, and capable of providing results in under ten minutes, making it suitable for safety-critical industries [6] Clinical Study Details - The first clinical study will involve 40 adults and will assess codeine detection cut-off levels using the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader [3] - The study will compare results with an FDA-cleared device and will utilize liquid chromatography-tandem mass spectrometry (LC-MS/MS) for corroboration [3] Market Potential - The U.S. drug screening market is the largest globally, with applications in workplace testing, criminal justice, pain management, and substance abuse treatment [4] - The company's technology offers advantages over traditional testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs [4] Strategic Partnerships - The company has partnered with Cliantha Research, a clinical research organization, to leverage its expertise in regulatory and clinical trials [2] - Subject recruiting and screening for the clinical study have already begun, with the first testing cohort starting on January 28, 2026 [5]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或依 賴該等內容而引致的任何損失承擔任何責任。 Mirxes Holding Company Limited （ 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ） （股份代號：2629） 自願性公告 於泰國的近期業務發展進程 本公告乃由Mirxes Holding Company Limited（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，旨在知會本公司股東及潛在投資者有關本集團的最新業務 發展。 與N HEALTH建立戰略夥伴關係 本公司董事（「董事」）會（「董事會」）宣佈，本公司已於2025年12月15日與N Health （「N Health」，為 一 家 醫 療 保 健 解 決 方 案 供 應 商 及 泰 國 最 大 醫 療 保 健 供 應 商 Bangkok Dusit Medical Services (BDMS) Group的成員公司）建立戰略夥伴關係（「戰 略夥伴關係」）。戰略夥伴關係旨在將先進的microRN ...

Core Viewpoint - Intelligent Bio Solutions Inc. has entered into a securities purchase agreement to raise approximately $10 million through a private placement of common stock and warrants, aimed at enhancing its working capital and general corporate purposes [1][2]. Group 1: Securities Offering - The company will issue 2,298,850 shares of common stock and associated Series K-1 and K-2 warrants, priced at $4.35 per share, with expected gross proceeds of around $10 million before expenses [1]. - The Series K-1 and K-2 warrants will have an exercise price of $4.10 per share and will be exercisable immediately upon issuance, with a term of five years [1]. - The closing of the private placement is anticipated on or about January 2, 2026, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized for working capital and general corporate purposes [2]. Group 3: Company Overview - Intelligent Bio Solutions Inc. specializes in medical technology, focusing on intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [5]. - The company's technology allows for quick sample collection and results in under ten minutes, targeting industries such as construction, manufacturing, and transport [5].

Core Viewpoint - Intelligent Bio Solutions Inc. will implement a 1-for-10 reverse stock split effective December 15, 2025, to enhance its stock price and maintain compliance with Nasdaq listing requirements [1][2]. Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on providing intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [4]. - The company aims to revolutionize portable testing via fingerprint sweat analysis, targeting industries such as construction, manufacturing, transport, and drug treatment organizations [4]. Reverse Stock Split Details - The reverse stock split will combine every 10 shares of common stock into one share, with no fractional shares issued; instead, stockholders will receive cash for any fractional shares [3]. - After the split, the par value of the common stock will remain at $0.01 per share, and the total number of authorized shares will stay at 100 million [3]. - Following the reverse split, approximately 959,533 shares of common stock will be issued and outstanding [3].

Core Insights - Grail is a leader in the multi-cancer early detection (MCED) market, with its stock rising 20.1% in November following positive third-quarter results and an analyst day [1] Company Overview - Grail's Galleri test screens for over 50 types of cancer and is the first MCED available commercially, although it has not yet received FDA approval, which management aims to achieve by the first half of 2026 [2] - The company faces competition from larger firms like Exact Sciences, which has its own MCED product, CancerGuard [2] Strategic Goals - Grail aims to grow commercial sales of Galleri while reducing cash burn, with a reported 39% year-over-year growth in Galleri tests in Q3, generating $32.6 million in revenue [3] - Cash burn has decreased to $59 million from $71.8 million in the previous quarter and $105.2 million a year ago [3] Financial Position - Following a successful private placement, Grail has a cash position of $850 million with no long-term debt, providing significant resources ahead of potential FDA approval for Galleri [4] Market Dynamics - The recent acquisition of Exact Sciences by Abbott Labs for a substantial premium underscores the attractiveness of the MCED market, raising speculation about potential acquisitions, including Grail [5] - Grail's Galleri test offers significant benefits for early cancer detection, positioning the company as a strong candidate for acquisition by larger firms [6] Acquisition Potential - Larger companies are likely to acquire firms like Grail and Exact Sciences due to their resources and market presence, with Grail being viewed as a more attractive acquisition target compared to Exact Sciences, which already has an FDA-approved product [7]

Core Insights - Thermo Fisher Scientific (TMO) has launched the Thermo Scientific SureTect Beverage Spoilage Multiplex qPCR assay, marking an industry-first all-in-one quantitative PCR-based test developed in collaboration with Coca-Cola Europacific Partners [1][2] Product Development - The new assay is part of the Thermo Scientific SureTect PCR System and allows for early and accurate detection of spoilage organisms in the beverage production process, applicable across the beverage testing industry [2] - The assay can detect over 100 strains of spoilage microorganisms, including preservative-resistant yeasts and molds, in a single qPCR reaction, which is a unique offering in the market [5] - By reducing testing time by up to 50% compared to traditional culture methods, the assay enhances manufacturers' confidence in batch release and improves consumer trust in beverage quality [6] Market Context - The global PCR market was valued at $4.90 billion in 2021 and is projected to grow at a CAGR of 8.7%, reaching $8.04 billion by 2027, driven by the rise in pathogen-related diseases and technological innovations [8] Financial Performance - Thermo Fisher has a market capitalization of $216.42 billion, with a Zacks Consensus Estimate forecasting a 3.9% increase in earnings and a 3.2% growth in revenues year-over-year [4] - TMO shares experienced a slight decline of 0.4% to close at $573.79 following the announcement, but the company has shown a positive trend with an 11.2% increase in share price over the past year compared to a 2.1% decline in the industry [3][11] Strategic Initiatives - In addition to the new assay, Thermo Fisher has opened an Advanced Therapies Collaboration Center in Philadelphia, enhancing its support for emerging startups and biopharma organizations [10]