# Diagnostic Tests * **Definition:** Medical tests conducted to determine the presence or absence of a disease or condition, which can include various types of tests performed on samples taken from the body, such as blood or stool, as well as tests that can be performed at home. * **Taxonomy:** Healthcare Topics / Diagnostic Tests ## News * Selected news on the topic of **Diagnostic Tests**, for healthcare technology leaders * 8.2K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 5/28/2025 | [**Ciba Health and ADA Join Forces to Transform Chronic Care - - HIT Consultant**](https://hitconsultant.net/2025/05/28/ciba-health-and-ada-join-forces-to-transform-chronic-care/) | [[HIT Consultant]] | | 5/12/2025 | [**The needs of the patient come first: How Mayo Clinic Laboratories' platform approach is advancing care and innovation**](https://www.beckershospitalreview.com/healthcare-information-technology/innovation/the-needs-of-the-patient-come-first-how-mayo-clinic-laboratories-platform-approach-is-advancing-care-and-innovation/) | [[Beckers Hospital Review]] | | 4/23/2025 | [**New startup Superpower scores $30M to offer personalized health testing**](https://www.fiercehealthcare.com/health-tech/new-startup-superpower-scores-30m-launch-personalized-health-testing) | [[FierceHealthcare]] | | 4/7/2025 | [**Shingles vaccine may cut dementia risk by 20Study**](https://www.beckershospitalreview.com/pharmacy/shingles-vaccine-may-cut-dementia-risk-by-20-study/) | [[Beckers Hospital Review]] | | 4/3/2025 | [**Pennsylvania hospital to close June 30**](https://www.beckershospitalreview.com/finance/pennsylvania-hospital-to-close-june-30/) | [[Beckers Hospital Review]] | | 1/13/2025 | [**Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma**](https://www.prnewswire.com/news-releases/roche-receives-fda-clearance-for-new-highly-sensitive-test-to-aid-clinicians-in-diagnosing-b-cell-lymphoma-302348583.html) | [[PR Newswire]] | | 1/12/2025 | [**Exact Sciences Announces Preliminary Fourth Quarter 2024 Results - Yahoo Finance**](https://finance.yahoo.com/news/exact-sciences-announces-preliminary-fourth-000000268.html) | [[Yahoo Finance]] | | 1/9/2025 | [**Geneoscopy closes $105 M in series C funding round to power next-generation of gastrointestinal diagnostic tests**](https://www.news-medical.net/news/20250109/Geneoscopy-closes-24105-M-in-series-C-funding-round-to-power-next-generation-of-gastrointestinal-diagnostic-tests.aspx) | [[News Medical Net]] | | 1/8/2025 | [**Geneoscopy Closes $105M in Series C Funding Round to Power Next-Generation of Gastrointestinal Diagnostic Tests**](http://www.businesswire.com/news/home/20250108387874/en/Geneoscopy-Closes-105M-in-Series-C-Funding-Round-to-Power-Next-Generation-of-Gastrointestinal-Diagnostic-Tests/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 1/3/2025 | [**Study highlights the importance of diagnostic tests in pandemic response**](https://www.news-medical.net/news/20250103/Study-highlights-the-importance-of-diagnostic-tests-in-pandemic-response.aspx) | [[News Medical Net]] | | 12/30/2024 | [**5 MedTech Stocks That Are Poised to Beat the Market in 2025 - Yahoo Finance**](https://finance.yahoo.com/news/5-medtech-stocks-poised-beat-140000672.html) | [[Yahoo Finance]] | | 12/4/2024 | [**5 Leading AI Companies Transforming Healthcare - by Technology,Ai,Tech,Health,Fitness - Medium**](https://medium.com/@arijitghosh646/5-leading-ai-companies-transforming-healthcare-74da16f8585c) | [[Medium]] | | 11/27/2024 | [**AI in Healthcare News and Updates**](https://www.healthitanswers.net/ai-in-healthcare-news-and-updates-112724/) | [[Health IT Answers]] | | 11/26/2024 | [**In-vitro Diagnostics Market to Grow by USD 22.17 Billion (2024-2028), Rising Geriatric Population and Disease Prevalence, Report on AI-Driven Market Trends - Technavio**](https://www.prnewswire.com/news-releases/in-vitro-diagnostics-market-to-grow-by-usd-22-17-billion-2024-2028-rising-geriatric-population-and-disease-prevalence-report-on-ai-driven-market-trends---technavio-302315568.html) | [[PR Newswire]] | | 11/22/2024 | [**Market Trends Report: Analyzing the Mobile Medical Device Connectivity Market's ... - LinkedIn**](https://www.linkedin.com/pulse/market-trends-report-analyzing-mobile-medical-device-w9qqe) | [[Linkedin]] | | 11/22/2024 | [**Dengue Virus Diagnostic Tests Market Research Report - LinkedIn**](https://www.linkedin.com/pulse/dengue-virus-diagnostic-tests-market-research-report-exploring-aadhe) | [[Linkedin]] | | 11/20/2024 | [**Companion Diagnostic Tests Market Growth Insights: Future Size and Scope Forecast**](https://www.linkedin.com/pulse/companion-diagnostic-tests-market-growth-insights-ygzec) | [[Linkedin]] | | 11/13/2024 | [**AI in Healthcare Market to Grow by USD 20.34 Billion (2024-2028), Driven by ... - PR Newswire**](https://www.prnewswire.com/news-releases/ai-in-healthcare-market-to-grow-by-usd-20-34-billion-2024-2028-driven-by-healthcare-digitization-ai-powered-report-highlights-market-transformation---technavio-302304148.html) | [[PR Newswire]] | | 10/23/2024 | [**The Healthcare Services market is projected to grow by USD 6.26 Billion from 2024-2028, driven by AI and the rising prevalence of chronic diseases, shaping market evolution - Technavio**](https://www.prnewswire.com/news-releases/the-healthcare-services-market-is-projected-to-grow-by-usd-6-26-billion-from-2024-2028--driven-by-ai-and-the-rising-prevalence-of-chronic-diseases-shaping-market-evolution---technavio-302284193.html) | [[PR Newswire]] | | 10/14/2024 | [**COVID-19 Diagnostic Tests Market Revolution: Size, Share & Emerging Trends (2024**](https://www.linkedin.com/pulse/covid-19-diagnostic-tests-market-revolution-size-share-emerging-evwpe?trk=public_post_embed_feed-article-content) | [[Linkedin]] | | 9/13/2024 | [**Employers expect health care benefit costs to keep rising-and they're going to have to ... - AOL.com**](https://www.aol.com/finance/employers-expect-health-care-benefit-121712413.html) | [[AOL]] | | 9/12/2024 | [**The Cardiology Information System (CIS) Market is projected to grow at a healthy CAGR of 8 ...**](https://dailyinvestorhub.com/the-cardiology-information-system-cis-market-is-projected-to-grow-at-a-healthy-cagr-of-8-10-over-the-next-few-years/) | dailyinvestorhub.com | | 9/9/2024 | [**Companion Diagnostic Tests in Oncology Market Size is Set to Achieve USD 17.0 Billion by 2034, with 9.5AGR: Transparency Market Research Inc.**](https://finance.yahoo.com/news/companion-diagnostic-tests-oncology-market-003000789.html) | [[Yahoo Finance]] | | 8/5/2024 | [**Digital Therapeutics Alliance CEO joins FDA Digital Health Advisory Committee and more ...**](https://www.mobihealthnews.com/news/digital-therapeutics-alliance-ceo-joins-fda-digital-health-advisory-committee-and-more-digital) | [[MobiHealthNews]] | | 6/27/2024 | [**Clinical Diagnostics Market Size to Hit USD 140.53 Billion by 2033 - BioSpace**](https://www.biospace.com/article/releases/clinical-diagnostics-market-size-to-hit-usd-140-53-billion-by-2033/) | biospace.com | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **Predica Diagnostics**: Develops targeted RNA sequencing tests for early cancer detection. - **Patho Care**: Specializes in non-invasive point-of-care diagnostic tests using a Raman spectroscopy-based platform. - **Abbott Laboratories**: A global healthcare company that develops and manufactures a wide range of diagnostic tests and devices. - **DELFI Diagnostics**: Focuses on AI-powered fragmentomics for early cancer detection, aiming to provide reliable and non-invasive tests. - **Aditxt, Inc.**: Focuses on precision health and developing diagnostic tests for critical health challenges. - **Bio-Rad Laboratories**: Specializes in diagnostic products and technologies, particularly in oncology. - **Thermo Fisher Scientific**: Provides a range of diagnostic solutions, including those for blood cancers. - **Exact Sciences Corp.**: A company focused on developing non-invasive tests for early cancer detection, including the Cologuard test for colorectal cancer. - **QHSLab Inc.**: A digital health company providing personalized medicine and point-of-care diagnostic tests. - **PixCell Medical Technologies Ltd.**: Develops AI-assisted home blood testing devices for real-time diagnostics. - **Becton Dickinson**: A leading company in the diagnostics sector, contributing to advancements in blood cancer detection. - **Ataraxis AI**: A precision medicine company developing AI-powered diagnostic tests, including the Ataraxis Breast test for breast cancer. - **Myriad Genetics, Inc.**: A molecular diagnostics company that offers genetic testing services to inform treatment decisions. - **PocDoc**: A digital diagnostics platform revolutionizing access to diagnosis and treatment through app-based technology. - **Roche Diagnostics**: A leading biotechnology company that has developed the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail for diagnosing B-cell lymphomas. - **Oxford BioDynamics Plc**: A biotechnology company focused on precision diagnostics, including cancer detection technologies. ### Partnerships and Collaborations - **DCN Dx and NIH-FDA ITAP**: Collaboration for the evaluation and authorization of the Xpert HCV test. - **Geneoscopy**: Collaborating to develop diagnostic tests for treatment selection and monitoring in patients with inflammatory bowel disease. - **MGI Tech and Predica Diagnostics**: Collaboration to develop targeted RNA sequencing tests for enhanced cancer detection. - **Exact Sciences and Mayo Clinic**: Collaboration on the development of non-invasive colorectal cancer screening tests, including Cologuard and Cologuard Plus. - **Geneoscopy and Labcorp**: Partnership to ensure broad availability of the ColoSense test for colorectal cancer screening. - **Ataraxis AI and Giant Ventures**: Collaboration to develop AI-powered diagnostic tests, including the Ataraxis Breast test for breast cancer. - **Hamershlag Private Capital Management and Patho Care**: A venture investment to enhance non-invasive point-of-care diagnostic tests utilizing Raman spectroscopy. - **MGI Tech Co.**: Collaborating to develop targeted RNA sequencing tests to enhance early cancer detection and personalized treatment strategies. - **Myriad Genetics and Lumea**: Integration of Myriad's molecular diagnostic tests into Lumea's digital pathology platform to streamline testing processes. - **Project-COMFORT**: A public-private partnership aimed at revolutionizing blood collection and diagnostics through innovative microsampling technology, involving 51 organizations. - **Bumrungrad International Hospital and Golden Helix**: A multiyear agreement to integrate genomic technology into clinical workflows for precision medicine. - **Light AI and MrBeast Industries**: Partnership to launch a Strep A test donation initiative in Africa aimed at improving healthcare access. - **Genoks and Velsera**: A partnership aimed at enhancing cancer diagnostics and treatment by integrating genomic expertise with advanced algorithms. - **QHSLab Inc. and Town Total Compounding**: Strategic partnership to enhance patient care through integrated digital healthcare solutions. - **MDIC (Medical Device Innovation Consortium)**: Promotes collaboration and inclusivity in medical product development and regulatory processes. - **UniDoc Health Corp. and Municipality of Aliano**: Collaborating to install an H3 Health Cube to improve primary healthcare services using advanced eHealth AI. - **Avant Technologies and Ainnova Tech**: Collaborating to expand Ainnova's healthcare technology presence in Latin America through a joint venture named Ai-nova Acquisition Corp. (AAC). - **Hospitex and UNOPS**: Contract for supplying IT and networking systems for hospitals in Ethiopia, enhancing healthcare digital transformation. - **careMESH and Epic**: Integration of the NAVIGATE platform into Epic's EHR systems to streamline patient navigation. - **HealthEdge and Codoxo**: Formed a strategic partnership to enhance payment integrity processes for healthcare payers. ### Innovations, Trends, and Initiatives - **Rapid Diagnostic Tests (RDTs) for Chagas Disease**: Proposed algorithm combining RDTs with conventional tests to improve diagnosis in resource-limited areas. - **Dengue Diagnostic Tests**: Market growth driven by increasing incidence rates and advancements in diagnostic technologies. - **Liquid biopsy technologies**: Non-invasive methods for detecting tumor-specific biomarkers, enhancing early cancer detection and treatment monitoring. - **Point-of-Care Diagnostics**: The market for point-of-care diagnostics is projected to grow significantly, driven by technological advancements and the need for rapid testing. - **AI-Driven Diagnostics**: The use of artificial intelligence to enhance the accuracy and efficiency of diagnostic tests, exemplified by Ataraxis AI's innovations. - **Point-of-Care Devices**: Technologies that enable rapid diagnostic testing at or near the site of patient care, improving access and efficiency. - **Digital PoC Devices**: Development of digital point-of-care devices that share results with healthcare professionals for further analysis. - **Cancerguard Test**: Aims to detect multiple cancers from a single blood draw using various biomarker classes to enhance sensitivity. - **Home Blood Testing Devices**: The market is growing due to technological advancements, allowing users to conduct tests at home with minimal training. - **Liquid Biopsy**: A non-invasive diagnostic method gaining traction for cancer detection and monitoring. - **Home blood testing devices**: Significant growth driven by technological advancements allowing users to conduct tests at home with minimal training. - **AI in Diagnostics**: AI-powered diagnostic tools are enhancing the accuracy of medical imaging, pathology, and genomics, leading to improved diagnoses and treatment plans. - **Microfluidics**: Rapidly expanding in healthcare for applications in diagnostics, enabling faster and more accurate testing. - **Digital diagnostics market growth**: Projected to exceed USD 6.32 billion by 2031, driven by advanced technologies improving disease identification and tracking. - **Companion Diagnostics**: Market growth driven by personalized medicine and advancements in biomarker discovery. - **VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail**: Innovative assay for assessing B-cell lymphoma subtypes, allowing for evaluation from a single tissue slide. - **Pilot Programs**: Commercial pilots in Chile and the Dominican Republic aim to demonstrate cost reductions and efficiency improvements in healthcare diagnostics. ### Challenges and Concerns - **FDA Regulations on Laboratory-Developed Tests (LDTs)**: New regulations may decrease access to diagnostic tests and lead to potential practice closures. - **Health Equity**: Efforts are needed to ensure equitable access to diagnostic tests and treatments. - **Ethical Concerns in Blood-Based Alzheimer's Tests**: Need to balance early detection benefits with ethical considerations regarding overdiagnosis and psychological impacts. - **High Costs and Accessibility**: Challenges in the widespread adoption of diagnostic tests due to high costs and limited access in rural areas. - **Low penetration of hepatitis B and C diagnostic tests**: Despite market growth, challenges remain in increasing awareness and access to these critical diagnostic tests. - **Regulatory Challenges**: Companion diagnostic tests face complex regulatory environments and high development costs. - **Regulatory Approval**: The need for regulatory compliance can slow down the introduction of new diagnostic tests to the market. - **Integration of New Technologies**: Slow integration of new diagnostic technologies into clinical practice remains a concern. - **Budget Constraints**: Healthcare organizations face financial limitations that impact the adoption of advanced diagnostic technologies. - **Antimicrobial Resistance**: A significant public health threat that requires innovative diagnostic approaches. - **Regulatory changes for laboratory-developed tests (LDTs)**: The FDA's reclassification of LDTs as medical devices raises concerns about innovation and compliance burdens on laboratories. - **Workforce Shortages**: A lack of skilled professionals in the diagnostics field poses challenges for effective implementation and operation. - **Regulatory Scrutiny of LDTs**: A recent court ruling halted the FDA's attempt to increase regulatory scrutiny over laboratory developed tests (LDTs), allowing them to continue operating without new regulations. - **Skilled Workforce Shortage**: A shortage of skilled professionals to operate advanced diagnostic tools may hinder market growth. - **Healthcare accessibility crisis in the U.S.**: Rising healthcare costs and limited access to diagnostic tests may hinder early detection and treatment. - **Regulatory Compliance**: Ongoing pressures related to regulatory compliance in the diagnostics industry, impacting innovation and market entry. - **Regulatory Restrictions**: Challenges remain regarding reimbursement models and regulatory frameworks for AI diagnostics. - **Intellectual Property Reluctance**: Companies' reluctance to share IP hinders collaboration and innovation in developing universal diagnostic platforms. - **Regulatory Frameworks**: The need for robust regulatory frameworks to ensure the ethical deployment of AI in healthcare diagnostics. - **Clinician Burnout**: The integration of AI in diagnostics raises concerns about the potential impact on clinician workload and burnout. ## Related Topics [[Clinical Diagnostics]]