CARLSBAD, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, announced today the acceptance of six abstracts at the 2025 American College of Rheumatology’s (ACR) annual meeting, ACR Convergence 2025, being held October 24-29, 2025, at the McCormick Place Convention Center in Chicago, Illinois. Exagen’s featured plenary presentation, in collaboration with Johns Hopkins University, will highlight a urinary biomarker panel that holds the potential to ...

CARLSBAD, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of innovative autoimmune testing, will release financial results for the quarter ended September 30, 2025, before the market opens on Tuesday, November 4, 2025. John Aballi, Exagen’s President and Chief Executive Officer, and Jeff Black, Chief Financial Officer, will host a conference call to review the company’s results at 8:30 a.m. ET (5:30 a.m. PT). Conference Call & Webcast: U.S. dial-in: 201-389-0918Intern ...

Core Insights - GRAIL, Inc. announced positive results from the PATHFINDER 2 study, demonstrating the effectiveness of the Galleri multi-cancer early detection test in identifying cancers at earlier stages and increasing detection rates significantly [1][2][4]. Group 1: Study Overview - PATHFINDER 2 is the largest U.S. multi-cancer early detection interventional study, involving 35,878 participants aged 50 and older with no clinical suspicion of cancer [1][11]. - The study evaluated the safety and performance of the Galleri test alongside standard cancer screenings, with results from 25,578 participants analyzed for performance and 25,114 for safety [1][2]. Group 2: Detection Rates and Performance - Adding Galleri to standard screenings for breast, cervical, colorectal, and lung cancers resulted in a more than seven-fold increase in cancer detection rates [2][7]. - Approximately 53.5% of new cancers detected by Galleri were stage I or II, and 69.3% were detected at stages I-III, indicating earlier detection [3][4]. - Galleri demonstrated a cancer signal detection rate of 0.93%, with a cancer detection rate of 0.57% and a positive predictive value of 61.6% [4][6]. Group 3: Diagnostic Efficiency - Galleri accurately identified the cancer signal origin 92% of the time, leading to efficient diagnostic evaluations with a median resolution time of 46 days [7][8]. - Only 0.6% of participants underwent invasive procedures, with invasive procedures being twice as common in participants diagnosed with cancer compared to those without [7][8]. Group 4: Future Plans and Regulatory Submission - GRAIL plans to submit data from the PATHFINDER 2 study to the U.S. FDA as part of the Galleri premarket approval application, expected to be completed in the first half of 2026 [8][9].

Core Viewpoint - Neogen (NEOG) is anticipated to report a year-over-year decline in earnings due to lower revenues, with the consensus outlook indicating potential impacts on its near-term stock price [1][2]. Earnings Expectations - The upcoming earnings report is expected to be released on October 9, with a consensus EPS estimate of $0.05 per share, reflecting a year-over-year decrease of 28.6% [3][12]. - Revenues are projected to be $203.18 million, down 6.4% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 12.5% over the last 30 days, indicating a reassessment by analysts [4]. - Neogen's Most Accurate Estimate aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a positive reading being a strong predictor of an earnings beat [9][10]. - Neogen currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [12]. Historical Performance - In the last reported quarter, Neogen was expected to post earnings of $0.08 per share but only achieved $0.05, resulting in a surprise of -37.50% [13]. - The company has not beaten consensus EPS estimates in any of the last four quarters [14]. Conclusion - Neogen does not appear to be a compelling candidate for an earnings beat, and investors should consider other factors when evaluating the stock ahead of its earnings release [17].

Safe Supply Streaming Co Ltd. and MDBio Sign U.S. Manufacturing Agreement for ToxiShield Products Amidst Record Federal Overdose Crisis FundingSeptember 30, 2025 8:17 AM EDT | Source: Safe Supply Streaming Co Ltd.Toronto, Ontario--(Newsfile Corp. - September 30, 2025) - Safe Supply Streaming Co Ltd. (CSE: SPLY) (OTCQB: SSPLF) (FSE: QM4) ("Safe Supply" or the "Company") today announced it has entered into a 12-month manufacturing and supply agreement with MobileDetect Bio, Inc. ("MDBio") to sup ...

Core Insights - Intelligent Bio Solutions Inc. (INBS) is progressing towards FDA 510(k) clearance for its Intelligent Fingerprinting Drug Screening System, specifically for opiate codeine, with an anticipated timeline for clearance in the second half of 2026 [2][3] - The company is initiating clinical studies to gather additional data to support its 510(k) submission, with studies expected to conclude in the first half of 2026 [3][4] - INBS's drug testing technology has been adopted by over 450 accounts across 24 countries, indicating a strong global presence and demand for its solutions [4] Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, aiming to revolutionize portable testing through fingerprint sweat analysis [5] - The Intelligent Fingerprinting Drug Screening System screens for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, providing results in under ten minutes [5] - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport, logistics, mining, drug treatment organizations, and coroners [5]

Core Insights - GRAIL, Inc. will present new data on the Galleri multi-cancer early detection test at the ESMO Congress 2025, highlighting its performance and safety from the PATHFINDER 2 study [1] - The results will also be submitted to the FDA as part of the Galleri Premarket Approval Application [1] - Additional updated results from the SYMPLIFY and REFLECTION studies will be presented at the Early Detection of Cancer Conference, showcasing Galleri's performance in symptomatic and veteran populations [1] Company Highlights - GRAIL, Inc. is focused on early cancer detection, aiming to identify cancer when it is still curable [1] - The company is leveraging data from its registrational PATHFINDER 2 study to support its claims regarding the Galleri test [1] - The upcoming presentations at major conferences indicate GRAIL's commitment to advancing its research and regulatory approval processes [1]

Core Insights - GRAIL, Inc. is recognized as one of the best-performing IPOs in the last two years, with significant growth since its IPO on June 25, 2024, showing an increase of 169.02% [1][3] Financial Performance - For the second quarter of 2025, GRAIL reported revenue of $35.5 million, which is an 11% increase compared to the previous quarter [2] - The company sold over 45,000 Galleri tests during the same quarter, indicating strong demand for its products [2] Partnerships and Research - GRAIL has established partnerships with major health systems, including Rush University System for Health, which enhances its market position [2] - Positive updates from the PATHFINDER 2 study in cancer detection further contribute to the company's optimistic outlook [2] Executive Activity - On August 20, 2025, GRAIL's President Joshua J. Ofman sold 4,202 shares for a total of $134,548, while CFO Aaron Freidin sold 877 shares valued at $28,081 [3] - The sales by top executives are interpreted as a signal of increased share value [3] Company Background - Founded in 2015, GRAIL, Inc. is focused on early cancer detection through its Galleri blood test, which utilizes next-generation sequencing and data science to identify multiple cancer types before symptoms appear [4]

Core Viewpoint - Intelligent Bio Solutions Inc. is progressing through the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System, which is a novel non-invasive testing solution [1][2][3]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA in December 2024, and received an Additional Information request in February 2025, which included over 70 items to address [2]. - INBS responded to the FDA's questions and submitted additional information in August 2025, but the FDA has requested further information, necessitating a resubmission of the 510(k) notification [3][4]. - The device is unique as there are no comparable sweat-based products currently on the market, requiring extensive validation to demonstrate its performance [3]. Company Strategy and Market Position - The company is consulting with specialized FDA consultants to evaluate the FDA's questions and plans to provide an investor update within ten days regarding the timeline for FDA clearance [4]. - The CEO expressed confidence in the technology and emphasized the company's commitment to bringing the solution to the U.S. market while continuing to grow its international business [5]. - INBS is developing partnerships and driving sales growth outside the U.S., targeting sectors such as construction, manufacturing, transport, and drug treatment organizations [6]. Product Overview - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive drug testing through fingerprint sweat analysis, screening for drugs commonly found in workplaces [6]. - The system offers quick sample collection and results in under ten minutes, making it a valuable tool for safety-critical industries [6].

Group 1 - Spectrum Health Science has transitioned into a life sciences organization focusing on next-generation solutions in Oral, Functional, and Women's Health [1] - The company announced the appointment of Damon Silvestry as the Chief Executive Officer of SimplyTest, its flagship salivary testing company [1] - Damon Silvestry brings over 20 years of leadership experience to the role [1]