Personalis (NasdaqGM:PSNL) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Speaker6Greetings, welcome to the Personalis fourth quarter 2025 earnings conference. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your ...

Key Takeaways VCYT Q4 EPS jumped 47% y/y to 53 cents, beating estimates as revenues rose 18.5% to $140.6M.VCYT testing revenues climbed 21%, fueled by Decipher and Afirma growth, and higher volumes.Veracyte expanded the gross margin to 74.4% and reiterated the 2026 revenue guidance of $570-$582M.Veracyte, Inc. (VCYT) delivered fourth-quarter 2025 adjusted earnings of 53 cents per share, up 47.2% from the year-ago period. The bottom line beat the Zacks Consensus Estimate by 30.06%.The company’s GAAP earnings ...

Core Insights - Intelligent Bio Solutions Inc. has successfully received and deployed its first shipment of Intelligent Fingerprinting Drug Screening Readers through a partnership with Syrma Johari, marking a significant step in scaling production capacity and validating the operational and financial benefits of the collaboration [1][3] - The partnership is expected to deliver annual production cost savings of over 40%, leading to an anticipated improvement of approximately 20 percentage points in gross margin annually [1][3] - The company has doubled its in-house production capacity for lateral flow test strips, enhancing vertical integration and accelerating research and development [1][4] Production and Manufacturing - The first shipment of readers is being deployed across key customer verticals such as construction, transportation, logistics, and manufacturing in the U.K. and Europe, supporting growing commercial demand [2] - The partnership with Syrma Johari has provided access to manufacturing capacity approximately four times greater than prior capabilities, allowing for accelerated fulfillment and cost savings [3] - The company has sourced advanced manufacturing equipment that has doubled its in-house production capacity for lateral flow test strips, improving margins and reducing lead times [4] Strategic Positioning - The successful deployment of the first shipment and increased production capacity positions the company to enter the U.S. market with operational strength and the ability to grow with demand [5] - The company is building a vertically integrated, cost-efficient manufacturing engine that supports margin expansion and accelerates innovation [5] - Additional production shipments are expected throughout 2026 as the company continues to build inventory and expand its commercial footprint [5] Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [6] - The system is designed to screen for recent drug use in workplace settings, providing results in under ten minutes, which is valuable for employers in safety-critical industries [6] - Current customer segments outside the U.S. include construction, manufacturing, transport, logistics, mining, drug treatment organizations, and coroners [6]

Core Viewpoint - 20/20 BioLabs has launched its OneTest for Longevity, a blood test that integrates inflammatory biomarkers, dietary habits, and scientific research to provide personalized health insights, utilizing IBM's watsonx.ai technology [1][2][3] Group 1: Product Launch and Features - The OneTest for Longevity solution calculates and displays an individual's risk of chronic diseases such as diabetes, dementia, and cardiovascular disease, offering personalized dietary recommendations based on biomarker levels [2] - The platform leverages IBM's advanced AI capabilities, including the Granite 4.0 foundation models and the Docling toolkit, to analyze nutritional research and deliver evidence-based health insights [3][6] - The test is available for purchase and is conducted in CLIA-licensed and CAP-accredited labs, although it has not sought FDA approval [3][7] Group 2: Partnerships and Technology - 20/20 BioLabs has partnered with DAISource to enhance its AI-enabled health solutions, aiming to improve public health through scalable and secure technology [3] - IBM's role is as an information technology provider, focusing on supporting enterprises with secure workloads in various sectors, including healthcare [4] Group 3: Company Background and Market Position - 20/20 BioLabs is an early market leader in laboratory-based blood tests for early detection and prevention of cancers and chronic diseases, with its stock listed on Nasdaq under the ticker symbol "AIDX" since February 19, 2026 [5][6] - The company also operates a Clinical Laboratory Innovation Accelerator (CLIAx) to assist overseas diagnostics startups in launching lab tests in the U.S. [8]

Initial 13-site deployment with UK subsidiary of global construction firm employing 35,600 employees across 50+ countries, validates commercial scalability and ROI of INBS’s fingerprint drug testing technologyNEW YORK, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced a partnership with Bouygues UK, a subsidiary of Bouygues Construction, a multi ...

Core Insights - GRAIL, Inc. reported significant commercial growth in 2025, with total revenue increasing by 17% year-over-year to $147.2 million and U.S. Galleri revenue growing by 26% to $136.8 million [1][4] - The company completed its Premarket Approval (PMA) submission to the FDA for the Galleri test and shared positive topline results from the NHS-Galleri trial, indicating a substantial reduction in Stage IV cancer diagnoses [1][2] - GRAIL's financial position remains strong, with cash and cash equivalents totaling $904.4 million as of December 31, 2025, providing financial flexibility for future growth [1][4] Financial Performance - For Q4 2025, total revenue was $43.6 million, a 14% increase year-over-year, while U.S. Galleri revenue reached $41.3 million, up 31% [1][4] - The net loss for Q4 2025 was $99.2 million, which includes $34.6 million in amortization related to the Illumina acquisition [1][4] - For the full year 2025, the net loss was $408.4 million, an improvement of $1.6 billion or 80% compared to the previous year [1][4] Business Highlights - GRAIL expanded access to the Galleri test through partnerships with digital health platforms, including the launch of the Hims & Hers Multi-Cancer Test [1][2] - The company completed the analysis of the full 35,000 participant PATHFINDER 2 study, demonstrating consistent performance with earlier results [1][2] - The NHS-Galleri trial results showed that adding Galleri to standard care screening significantly increased the detection rates of early-stage cancers [1][2] Cash Position - As of December 31, 2025, GRAIL had cash, cash equivalents, and short-term marketable securities totaling $904.4 million, ensuring operational sustainability into 2030 [1][4] Future Outlook - GRAIL anticipates continued commercial growth in 2026, with plans for new partnerships in digital health and further integration into health systems [1][2] - Detailed results from the PATHFINDER 2 and NHS-Galleri trials are expected to be presented in mid-2026 [1][2]

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]