Key points from Dr. Temte's discussion include: This episode reflects QuidelOrtho's commitment to equipping healthcare providers and the public with timely, actionable information. By highlighting expert insights and practical solutions, QuidelOrtho aims to reduce illness spread and safeguard community health. The QuidelOrtho Science Bytes podcast is available on major streaming platforms and at: https://www.quidelortho.com/global/en/resources/podcasts/quidelortho-science-bytes. About QuidelOrtho Corporatio ...

FRIENDSWOOD, Texas, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its executive management is scheduled to present a company overview at Baird's 2025 Global Healthcare Conference on Wednesday, Sept. 10, 2025, at 10:15 a.m. Eastern time. A live audio webcast of the Company's presentation will be available by visiting Castle Biosciences' website at ir.castlebiosciences.com/events-pres ...

Core Insights - Biodesix has been designated as a Thermo Fisher Scientific Center of Excellence (COE), enhancing its role in advancing NGS-based diagnostics for solid tumors [1][2] - The collaboration with Thermo Fisher has led to the validation of the Oncomine Dx Express Test, which is crucial for the FDA approval of the Genexus Dx Integrated Sequencer [2][3] - Biodesix aims to expand its molecular diagnostic and NGS testing capabilities, particularly in tissue-based profiling, as part of its commitment to improving cancer diagnosis and care [3] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung Cancer Treatment Guidance, which support personalized care [4] - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions [4] Thermo Fisher COE Network - The Thermo Fisher NGS COE Network collaborates with global institutions to develop and refine the Ion Torrent™ Oncomine™ solutions portfolio [5] - This network aims to accelerate oncology research and advance precision medicine through strategic alliances [5]

Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies designed to detect and analyze nucleic acid molecules (DNA or RNA) [6] - The company utilizes proprietary technology to create specific tests for its Co-Dx PCR at-home and point-of-care platform, as well as to identify genetic markers for applications beyond infectious disease [6] Upcoming Events - Co-Diagnostics will host a booth at the 17th Annual Next Generation Dx Summit, taking place both virtually and in-person at the Capital Hilton in Washington, D.C. from August 18-20, 2025 [1] - Attendees are encouraged to visit Booth 12 to learn about the Co-Dx Logix Smart® suite of clinical laboratory solutions and the upcoming Co-Dx PCR diagnostics platform, which includes tests for upper respiratory infections, tuberculosis, and HPV, expected to enter clinical evaluations in 2025 [3] Industry Context - The Next Generation Dx Summit serves as a platform for international thought leaders to network and discuss advancements in diagnostics and technology innovation, focusing on areas such as point-of-care testing, decentralized testing, infectious diseases, liquid biopsy, and companion diagnostics [2]

Summary of Insight Molecular Diagnostics (IMDX) Update / Briefing Company Overview - **Company**: Insight Molecular Diagnostics (IMDX) - **Event Date**: August 15, 2025 - **Focus**: Development and commercialization of donor-derived cell-free DNA (dd-cfDNA) testing for transplant patients Key Industry Insights - **Transplant Market**: The U.S. transplant market is highly concentrated with approximately 250 transplant centers, where around 100 centers handle most of the volume [6][7] - **Standard of Care**: dd-cfDNA testing has become a standard of care in the transplant space over the past six to seven years, primarily dominated by a few central labs in California [6][7] - **Local Care Strategy**: IMDX aims to empower local transplant centers to manage their patients using their technology, thereby improving patient care [5][6] Core Company Strategies - **Market Approach**: IMDX employs a "land and expand" strategy, starting with a service lab in Nashville, Tennessee, and expanding to IVD kits for local use [8][10] - **FDA Submission**: The company is working towards FDA approval by validating the accuracy of their test in clinical studies, expecting to submit a dossier by the end of the year [11][13] - **Clinical Study**: The study aims to demonstrate non-inferiority to existing dd-cfDNA tests, with an expected enrollment of 125 to 150 patients [11][12] Clinical Insights from Dr. Anthony Langone - **Cell-Free DNA Testing**: The test has a 96% negative predictive value, effectively ruling out rejection and potentially reducing the need for costly biopsies, which can exceed $30,000 [24][25] - **CMS Coverage**: The Centers for Medicare & Medicaid Services (CMS) has expanded coverage for surveillance biopsies, allowing for more frequent testing in kidney transplant patients [28][60] - **Emerging Applications**: The technology may also detect cancers and improve outcomes in patients with antibody-mediated rejection through new therapies [31][34] Challenges and Opportunities - **Logistical Issues**: Current testing requires samples to be sent to California, leading to delays in patient care. IMDX's new technology aims to provide same-day results, which could significantly improve patient management [38][68] - **Adoption Barriers**: Transitioning from established providers to IMDX's in-house testing may face resistance, but the speed and convenience of the new technology could drive adoption [50][92] - **Regulatory Landscape**: The FDA's evolving stance on surveillance testing is seen as a positive development for the adoption of dd-cfDNA testing [74] Financial Considerations - **Cost-Effectiveness**: Transplantation is significantly less expensive than dialysis, with a transplant costing around $85,000 compared to $100,000 to $105,000 per year for dialysis [63] - **Market Growth**: The number of kidney transplants has increased, with over 27,500 performed last year, reflecting a 10% growth [61] Conclusion - IMDX is positioned to capitalize on the growing demand for efficient and effective transplant monitoring solutions through its innovative dd-cfDNA testing technology. The company is focused on enhancing local care capabilities, navigating regulatory challenges, and addressing logistical barriers to improve patient outcomes in the transplant community.

Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for Q2 2025, highlighting developments in its Co-Dx PCR testing platform and the need for regulatory approval before market availability [2][3]. Financial Results - The company released its financial results for the second quarter ended June 30, 2025, which are available on its website [2]. Management Remarks - The conference call included prepared remarks from the CEO Dwight Egan and CFO Brian Brown, followed by a Q&A session with analysts [2]. Forward-Looking Statements - The company made forward-looking statements regarding its Co-Dx PCR testing platform, emphasizing that it requires regulatory approval and is not currently for sale [3][4].

Core Insights - 2025 is a crucial year for Volition as it aims to commercialize its Nu.Q® platform in the human diagnostics market, currently in discussions with over ten companies [1][2] - The company is progressing through various stages of partnership development, including due diligence and contract finalization, with expectations to sign its first agreement in the human diagnostics space this quarter [2][4] - Volition's Nu.Q® technology shows strong clinical evidence for applications in cancer and sepsis, which are areas of increasing interest for pharmaceutical companies [3][4] Business Strategy - The goal for 2025 includes securing multiple licensing agreements in the human diagnostics sector, similar to its successful strategy in the veterinary market, with diverse deal structures anticipated [4] - The company expects potential for upfront and milestone payments, as well as future recurring revenue from these agreements [4] Financial Performance - Volition recorded over $0.4 million in revenue for Q2 2025, marking a 15% growth compared to the same period last year [8] - The net loss decreased by 11% for the quarter and 24% for the first half of 2025 compared to the previous year [8] - Cash used in operating activities for the first half of 2025 was $10.6 million, down 30% year-over-year, with cash and cash equivalents totaling approximately $2.3 million as of June 30, 2025 [8]

Company remains on track to initiate clinical evaluations for all tests in Co-Dx PCR platform* pipeline before year-end, and is currently training clinical evaluation sites for enhanced COVID-19 test and expects to begin accepting trial participants imminently Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, "The investments made during the course of developing the Co-Dx PCR platform from the ground-up have all contributed to the robust manufacturing, development, and regulatory framework r ...

Core Insights - Microbix Biosystems Inc. reported disappointing financial results for Q3 and YTD 2025, with significant declines in revenue and net loss compared to the previous year [1][2][6] Financial Performance - Q3 revenue was $3.5 million, a 31% decrease from $5.1 million in Q3 2024, driven by a 44% drop in antigen sales and a 9% decline in QAPs sales [3][11] - Year-to-date (YTD) revenue was $14.8 million, down 22% from $19.1 million in YTD 2024, with antigen revenues up 11% but QAPs revenues down 25% [7][11] - Gross margin for Q3 was 41%, down from 54% in the previous year, primarily due to a less favorable product mix [4][11] - YTD gross margin was 56%, down from 63% in YTD 2024, affected by lower sales of higher-margin products [8][11] Operating Expenses - Operating expenses in Q3 increased by 22% compared to Q3 2024, influenced by lower investment income and the absence of grant income [5][11] - YTD operating expenses rose slightly due to increased investment in R&D and sales and marketing activities [8][11] Net Loss and Cash Flow - The company reported a net loss of $1.6 million for Q3, compared to a net income of $246,746 in Q3 2024 [6][11] - YTD net loss was $765,150, a significant decline from a net income of $3.1 million in YTD 2024 [9][11] - Cash used in operating activities was $1.9 million for Q3, compared to cash provided of $604,064 in Q3 2024 [6][11] Financial Position - As of June 30, 2025, the company had strong cash and equivalents of $12.1 million, with a current ratio of 9.73 and a debt to equity ratio of 0.30, both improved from the previous year [10][11] Corporate Outlook - Management remains cautious about the outlook for the remainder of fiscal 2025, particularly due to reduced sales into China [2][12] - The company aims to drive sales growth across all business lines while improving gross margins and bottom-line results [12]

Investor FORWARD LOOKING STATEMENTS Except for the historical information contained herein, this document contains forward tooking statements within the meaning of the Privates Securities Litigation Reform A stakements regarding our stralegy, plans, objectives and intitatives, including our expectations regarding the tubue revenue growth potential of each of our substitiance, for commercializing our BE-Smart Esophageal Cancer Test, our expectations regarding future liquidity events, the success of our effor ...