OraSure Technologies, Inc.

SPRINGDALE, Ark.--( BUSINESS WIRE )--NOWDiagnostics, Inc. ( NOWDx ), a leader in developing over-the-counter (OTC) and point-of-care (POC) diagnostic tests, filed a claim on Jan. 13 against OraSure Technologies (OraSure), asserting breach of contract, theft of a non-public device, misappropriation of trade secrets, unfair competition, and other violations of state and federal law for damages in federal court in the Eastern District of Pennsylvania. NOWDx is seeking compensatory and punitive damages and payment of attorneys’ fees, among other legal remedies. “ Our focus on our mission to provide the public with diagnostic products that improve lives remains unwavering,” said Robert Weigle, CEO of NOWDx. “ I’m immensely proud of our team and the progress we’ve made with our patented, accurate, easy-to-use, rapid technology. This includes the launch of the first and only rapid syphilis test with in-home results in minutes, the First to Know Syphilis Test, addressing a growing national epidemic. We regret that previous discussions with OraSure have ended in litigation. However, we are confident in our legal position and plan to vigorously defend our innovative intellectual property.” NOWDx’s countersuit asserts a pattern of unlawful actions by OraSure beginning in 2023, after it had approached NOWDx to discuss NOWDx’s technology and potential to expand OraSure’s product portfolio. The evidence of OraSure’s wrongdoing was recently uncovered by an internal investigation after OraSure filed a baseless lawsuit against NOWDx in November 2024. NOWDx is pursuing claims against OraSure for, among other things: OraSure’s illegal retention of a non-public NOWDx prototype and in-market devices; OraSure’s efforts to develop product technology using confidential information it learned during discussions with NOWDx; OraSure’s improper retention of NOWDx’s highly confidential information, including detailed product roadmaps and specific technical documents; The access and use of NOWDx’s proprietary data and information by senior members of OraSure’s team; OraSure’s attempts to internally develop the same products NOWDx had presented to it during discussions between the parties; and OraSure’s retention of NOWDx’s confidential, trade secret information that was shared in 2023. About NOWDiagnostics (NOWDx) NOWDx develops and manufactures over-the-counter (OTC) and point-of-care (POC) diagnostic tests. Its patented approach enables virtually any immunological assay to be accurately performed onsite in one step using a small amount of capillary blood, yielding results in minutes. With over 75 patents issued and pending, NOWDx's First To Know ® and ADEXUSDx ® product lines are available in markets worldwide. Founded in 2013, with headquarters and manufacturing in Springdale, Arkansas, NOWDx envisions a world where people have greater access to in-home testing with results in minutes. NOWDx is committed to changing healthcare by providing accessible, affordable, and accurate testing for all. Please visit nowdx.com for more information.

DUBLIN--( BUSINESS WIRE )--The "Clinical Laboratory Molecular Diagnostics for Infectious Disease Market: Forecasts by Application by Place and by Country, with Market Analysis & Executive Guides" report has been added to ResearchAndMarkets.com's offering. The report has hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing along with the most frequently used and billed tests. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report. The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for further growth. A market that just keeps on growing but is becoming more complex and segmented. Find out what's happening in this informative report. Find out about the impact of multiplex assays which threaten to change diagnosis and treatment forever. Exciting technical developments especially in the seesaw between nucleic acid testing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication. This research makes you the expert in your organization. The report includes five year market forecasts. The section on the Clinical Laboratory Market Segments and Industry Structure provides an analysis of the laboratory market, detailing traditional segmentation and focusing on specific areas like syndromic testing. It explores how different types of labs, including hospital labs, central labs, and physician office labs (POLs), segment their services based on testing needs. The industry structure section discusses the distribution of testing among hospitals, the economies of scale achieved by larger lab networks, and the competition between hospital-based labs and centralized laboratories. It also highlights the role of physician offices and the growing relevance of Point-of-Care Testing (POCT), reflecting the shifting dynamics in where and how diagnostic testing is conducted. This summary encapsulates the key market dynamics and structural elements of the clinical laboratory industry. Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this new report. A range of dynamic trends are pushing market growth and company valuations. Trends like Multiplex testing Pathogen evolution and pandemics Biotechnology advances in genetics Climate change Globalization The rise of rapid testing Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 2 Introduction and Market Definition 2.1 Market Definition 2.2 Methodology 2.3 Perspective: Healthcare and the IVD Industry 2.3.1 Global Healthcare Spending 2.3.2 Spending on Diagnostics 2.3.3 Important Role of Insurance for Diagnostics 2.4 The Nature of the IVD Product 2.4.1 Features Overview 2.4.2 The Misunderstood Feature 2.4.3 Regulation 2.4.4 The Newest Feature 2.4.5 The Oldest Feature 2.4.6 All About Scope 2.4.7 Why Turnaround is Becoming More Important 2.4.8 The Role of Trust 2.5 The IVD Product of the Future 3 Infectious Diseases - Guide to the Pathogens 3.1 Infectious Disease Pathogens - The Big Picture 3.1.1 Viruses 3.1.2 Bacteria 3.1.3 Fungi 3.1.4 Parasites 3.1.5 Prions 3.1.6 Virulence 3.1.7 Transmission 3.2 The Coronavirus 3.2.1 Severe acute respiratory syndrome (SARS) 3.2.2 Middle East respiratory syndrome (MERS) 3.2.3 COVID-19. The SARS CoV 2 Virus. 4 Industry Overview 4.1 Players in a Dynamic Market 4.1.1 Academic Research Lab 4.1.2 Diagnostic Test Developer 4.1.3 Instrumentation Supplier 4.1.4 Chemical/Reagent Supplier 4.1.5 Pathology Supplier 4.1.6 Independent Clinical Laboratory 4.1.7 Public National/regional Laboratory 4.1.8 Hospital Laboratory 4.1.9 Physicians Office Lab (POLS) 4.1.10 Audit Body 4.1.11 Certification Body 4.2 The Clinical Laboratory Market Segments 4.2.1 Traditional Market Segmentation 4.2.2 Laboratory Focus and Segmentation 4.2.3 Segmenting the Syndromic Testing Market 4.3 Industry Structure 4.3.1 Hospital Testing Share 4.3.2 Economies of Scale 4.3.3 Hospital vs. Central Lab 4.3.4 Physician Office Labs 4.3.5 Physicians and POCT 5 Market Trends 5.1 Factors Driving Growth 5.1.1 The Nucleic Acid Impact 5.1.2 Population Dynamics 5.1.3 The Developing World 5.1.4 Decentralization 5.1.5 Self Testing 5.1.6 The Need for Speed 5.2 Factors Limiting Growth 5.2.1 Costs and Experience Curve Effects 5.2.2 The Role of ID Prevalence 5.2.3 Wellness 5.2.4 The Impact of Living Standards 5.3 Instrumentation, Automation and Diagnostic Trends 5.3.1 Traditional Automation and Centralization 5.3.2 The New Automation, Decentralization and Point Of Care 5.3.3 Instruments Key to Market Share 5.3.4 Bioinformatics Plays a Role 5.3.5 PCR Takes Command 5.3.6 Next Generation Sequencing Fuels a Revolution 5.3.7 NGS Impact on Pricing 5.3.8 Whole Genome Sequencing, A Brave New World 5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 6 Clinical Laboratory MDx Infectious Disease Recent Developments 6.1 Recent Developments - Importance and How to Use This Section 6.1.1 Importance of These Developments 6.1.2 How to Use This Section 6.2 Roche Respiratory Panel Receives FDA EUA 6.3 Genetic Signatures Gets Approval for GI Parasite Panel 6.4 Diasorin Expands Respiratory Panel 6.5 BioMerieux Outlines MDx-Driven Growth 6.6 T2 Biosystems Gets Extended T2Bacteria Panel 6.7 Diasorin Aims to Deliver Updated Instruments, New Assays 6.8 Oxford Nanopore Nabs Investment From BioMerieux 6.9 Day Zero Diagnostics Closes Financing Round 6.10 Spindiag Seeks Investors for Rapid PCR System 6.11 Sorrento Therapeutics Nabs Contract for Dx Platform 6.12 Kephera Planning Menu of Infectious Disease Tests 6.13 Oxford Nanopore and BioMerieux to Develop IDDx 6.14 SD Biosensor Eyes Global Expansion 6.15 Selux Dx Next Gen Phenotyping Gets FDA Clearance 6.16 Takara Developing High-Throughput Multiplex Panels 6.17 BioGX Debuts New Point-of-Care Molecular Testing System 6.18 Nanopath MDx Platform Providing 15-Minute Results 6.19 ProtonDx Commercializing Rapid MDx Instrument 6.20 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform 6.21 Hologic Obtains CE Mark for MDx Epstein-Barr, BK Virus Assays 6.22 Pathogenomix Infectious Disease Platform Uses Cloud-Based Analytics, NGS 6.23 Accelerate Diagnostics Anticipates Growth 6.24 Growth of Decentralized Testing Expected to Continue 6.25 Lumos Diagnostics Expanding Test Portfolio 6.26 Study Validates Karius Cell-Free DNA to Detect Hundreds of Pathogens 6.27 CareDx, IDbyDNA Develop Infectious Disease Dx for Transplant Patients 7 Key Companies 7.1 Abbott Laboratories 7.2 Agilent 7.3 Altona Diagnostics 7.4 Anitoa 7.5 Autonomous Medical Devices 7.6 Beckman Coulter Diagnostics (Danaher) 7.7 Becton, Dickinson and Company 7.8 BioGX 7.9 Biomatik 7.10 bioMerieux Diagnostics 7.11 Bio-Rad Laboratories, Inc 7.12 Cepheid (Danaher) 7.13 Diasorin S.p.A. 7.14 DNAe 7.15 Flow Health 7.16 Global Access Diagnostics 7.17 Great Basin Scientific, Inc 7.18 Hologic 7.19 Novacyt 7.20 Novus Diagnostics 7.21 Oncimmune 7.22 One Codex 7.23 OraSure Technologies 7.24 Proof Diagnostics 7.25 Qiagen 7.26 QuidelOrtho 7.27 R-Biopharm AG 7.28 Response Biomedical 7.29 Revvity 7.30 Roche Diagnostics 7.31 Siemens Healthineers 7.32 Thermo Fisher Scientific 7.33 Vela Diagnostics 7.34 Veredus Laboratories 7.35 YD Diagnostics 7.36 Zhejiang Orient Gene Biotech 8 The Global Market for Clinical Laboratory MDx Infectious Disease 8.1 Global Market Overview by Country 8.2 Global Market by Application - Overview 8.3 Global Market by Place - Overview 9 Global Clinical Laboratory MDx Infectious Disease Markets - By Application 9.1 Respiratory 9.2 Blood Borne Virus 9.3 Transplant 9.4 Hospital Acquired Infections 9.5 Reproductive Health 9.6 C19 Singleplex 9.7 Meningitis 9.8 Gastrointestinal 9.9 Tropical 10 Global Clinical Laboratory MDx Infectious Disease Markets - By Place 10.1 Hospital Lab 10.2 Outpatient Lab 10.3 Point of Care 10.4 Other Place 11 Appendices 11.1 Growth of Approved IVD Test Menu 11.2 Growth of Approved Average IVD Test Fee 11.3 The Most Used IVD Assays 11.4 The Highest Grossing Assays 11.5 Laboratory Fees Schedule For more information about this report visit https://www.researchandmarkets.com/r/fte25m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

DUBLIN--( BUSINESS WIRE )--The "OTC/DTC Infectious Disease Diagnostics Strategies and Trends for Over the Counter and Direct To Consumer: Forecasts by Application by Channel and by Country with Market Analysis and Executive Guides" report has been added to ResearchAndMarkets.com's offering. The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report. The report includes five year market forecasts. The sleeping giant of Over the Counter and Direct to Consumer Diagnostics is set to create a broad new diagnostic industry. New technologies create rapid test solutions for the home market. Genetic testing led the way. Now Infectious disease testing is moving directly to the consumer. New sampling technology, rapid and multiplex tests have changed the picture of how and where testing is done. And the pandemic has proven the need for self-testing. This report explores the DTC outlook. Find out where the action is and learn about the players. Exciting technical developments hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication. Even newer diagnostics are now coming into play. The report has hundreds of pages of information including a complete list and analysis of Current United States Medicare Fee Payment Schedules to help sharpen your pricing. Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 1.2 Guide for Executives and Marketing Staff 1.3 Guide for Investment Analysts and Management Consultants 2 Introduction and Market Definition 2.1 What is OTC and DTC Testing? 2.2 OTC/DTC Testing - the quiet revolution in diagnostics 2.3 Self vs. Send - who knew? 2.4 Market Definition 2.5 Methodology 2.6 Perspective: Healthcare and the IVD Industry 2.6.1 Spending on Diagnostics 2.6.2 Important Role of Insurance for Diagnostics 3 The Infectious Diseases - Guide to the Pathogens 3.1 Infections - The Big Picture 3.2 The Pathogens 3.2.1 Bacteria 3.2.2 Fungi and Protozoa 3.2.3 Viruses 3.2.4 Prions 3.2.5 Symptoms and Syndromes 3.2.6 Bacterial or viral 3.2.7 Typical Viral Symptoms 3.2.8 Typical Bacterial Symptoms 3.3 Disease 3.4 Transmission 3.5 Infectious Disease Diagnostics 3.5.1 Microbial culture 3.5.2 Microscopy 3.5.3 Biochemical tests 3.5.4 PCR-based diagnostics 3.5.5 Metagenomic sequencing 3.6 Defining Infections 3.7 Syndromic Infection 4 Industry Overview 4.1 Industry Participants 4.1.1 IVD Supplier 4.1.2 Independent lab specialized/esoteric 4.1.3 Independent lab national/regional 4.1.4 Independent lab analytical 4.1.5 Public National/regional lab 4.1.6 Hospital lab 4.1.7 Physician lab 4.1.8 Pharmacies 4.1.9 Audit body 4.2 The Clinical Laboratory Market Segments 4.2.1 Traditional Market Segmentation 4.2.2 Laboratory Focus and Segmentation 4.2.3 Segmenting the OTC/DTC Market 4.3 Industry Structure 4.3.1 Hospital Testing Share 4.3.2 Economies of Scale 4.3.3 Hospital vs. Central Lab 4.3.4 Physician Office Lab's 4.3.4.1 The Problem with POLS 4.3.5 Physician's and OTC/DTC 4.3.6 Pharmacies and OTC/DTC 4.3.6.1 The Diagnostic Plight of Pharmacies - Trying to do good 4.3.6.2 The Theranos Legacy 5 Market Trends 5.1 Factors Driving Growth 5.1.1 Privacy and Anonymity 5.1.2 The Internet Effect 5.1.3 Rapid Result 5.1.4 The Wellness Movement 5.1.5 The COVID-19 Impact 5.2 Factors Limiting Growth 5.2.1 Trust Factor 5.2.2 Infectious Disease is Declining But.. 5.2.3 Wellness Hurts 5.2.4 Economic Growth improves Living Standards 5.3 Diagnostic Technology Development 5.3.1 The Multiplex Paradigm Shift 5.3.2 NAT vs. Lateral Flow 5.3.3 The Unusual Role of GPS 5.3.4 Self and Send Competition 5.3.5 The Relationship to DTC Genetic 5.3.6 The Relationship to TeleHealth 5.3.7 Sample Collection - Who Knew? 6 Recent Developments 6.1 Importance and How to Use This Section 6.1.1 Importance of These Developments 6.1.2 How to Use This Section 6.2 Silicon Valley Building Online Wellness Market 6.3 Simple HealthKit partners with Amazon 6.4 The future of at-home molecular testing 6.5 OTC Self-Tests, Tempered by Lack of Reimbursement 6.6 LetsGetChecked Gets FDA STD Test Approval 6.7 DiagMetrics Developing Breath Assays 6.8 Co-Diagnostics Awarded $2.3M for TB, HPV Tests 6.9 POC Developers Nuclein and Minute Molecular Dx Merge 6.10 ReadyGo Dx to Make MDx Testing a 'Snap' 6.11 Altratech Enters POC Space Supplanting PCR 6.12 FDA Authorizes First OTC Home Test for both Influenza and COVID-19 6.13 Pharmacies Poised to Capture At-Home Diagnostics Category 6.14 How Labcorp, Abbott, BD, Siemens plan to expand home testing market 6.15 Morgan Health Invests in LetsGetChecked 6.16 New US$ 1 price for HIV self-tests 6.17 Startup Detect to Roll Out Next-Gen Molecular Instrument 6.18 Diagnostics for the Real World Third-Generation POC Platform 6.19 Labcorp Partnering With Getlabs for Home Collection 6.20 Salignostics Closes Funding Round 6.21 Cue Health Targets DTC Market in 2022 6.22 Grip Molecular Developing Home Respiratory Panel 6.23 Mainz Biomed Developing Home ColoAlert Assay 6.24 MFB Fertility Closes Series A Financing Round 6.25 Continued Demand for SARS-CoV-2 Rapid Tests 6.26 Rapid COVID-19 Test Results Risk Going Uncounted 6.27 FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit 6.28 Researchers Develop 15-Minute PCR System 6.29 Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test 6.30 Lucira Health Files for $115M IPO 6.31 Spectrum Solutions Gets CE Mark for Saliva Collection Devices 6.32 Sherlock Biosciences Receives Gates Foundation Grant for COVID-19 Self-Test 6.33 LabCorp Receives EUA for OTC COVID-19 Test Home Collection Kit 6.34 FemtoDx Launches Rapid At-Home Test Development for COVID-19 6.35 FDA approves first at-home coronavirus test 6.36 Free Home HIV Tests Detect More Infections 6.37 Biohacking trend supports self testing. 6.38 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market 6.39 Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test 6.40 OraSure Technologies, Inc. Announces Two Acquisitions 6.41 Nigerian Govt Approves Alere HIV Self-Test Kit 6.42 Boots launches UTI test and treat service across 37 branches 6.43 Scanwell Health moves beyond home UTI testing 6.44 Healthy.io raises $18 million for at-home urinalysis tests 6.45 LetsGetChecked collects $30M more for at-home health testing 6.46 TestCard, a $4 Urine Test Read by Smartphone 6.47 Digital Health Startup EverlyWell Raises $50M 6.48 Thriva adds test-at-home kits for female hormone and cortisol stress 6.49 Tasso scores $6.1M for patch-based home blood testing 6.50 DBS Systems HEMAXIS receives CE/IVD mark 6.51 Abbott HbA1c point-of-care test reliably diagnoses diabetes 7 Profiles of Key Diagnostic Testing Companies 7.1 1DropDiagnostics 7.2 Abbott Laboratories 7.3 Accel Diagnostics 7.4 Ador Diagnostics 7.5 ADT Biotech 7.6 Akonni Biosystems 7.7 AlphaBiolabs 7.8 Alveo Technologies 7.9 Applied BioCode 7.10 Atomo Diagnostics 7.11 Aureum Diagnostics 7.12 Aus Diagnostics 7.13 Becton, Dickinson and Company 7.14 Binx Health 7.15 Biocartis 7.16 BioFire Diagnostics (bioMerieux) 7.17 bioMerieux Diagnostics 7.18 Bio-Rad Laboratories, Inc 7.19 Bosch Healthcare Solutions GmbH 7.20 Cepheid (Danaher) 7.21 Cue Health 7.22 Curetis (OpGen) 7.23 DBS Systems 7.24 Detect 7.25 Diagenode Diagnostics (Hologic) 7.26 Diasorin S.p.A. 7.27 Domus Diagnostics 7.28 Ellume 7.29 Everywell 7.30 Getlabs 7.31 Grip Molecular Technologies 7.32 Healthy.io 7.33 Hologic 7.34 Inflammatix 7.35 Invetech 7.36 J&J Innovative Medicine 7.37 Karius 7.38 Laboratory Corporation of America 7.39 Letsgetchecked 7.40 LightDeck Diagnostics 7.41 Lucira Health (Pfizer) 7.42 LumiraDx 7.43 Meep 7.44 MFB Fertility 7.45 myLabBox 7.46 Nanomix 7.47 OraSure Technologies 7.48 Oxford Nanopore Technologies 7.49 Panagene 7.50 Prenetics 7.51 Primerdesign (Novacyt) 7.52 Prominex 7.53 Qiagen 7.54 QuantuMDx 7.55 Quest Diagnostics 7.56 QuidelOrtho 7.57 Randox Toxicology 7.58 R-Biopharm AG 7.59 Response Biomedical 7.60 Roche Diagnostics 7.61 Salignostics 7.62 SD Biosensor 7.63 Seegene 7.64 Sekisui Diagnostics 7.65 Siemens Healthineers 7.66 T2 Biosystems 7.67 TestCard 7.68 Thermo Fisher Scientific 7.69 Thriva 7.70 Visby Medical 7.71 XCR Diagnostics 7.72 YourBio Health 8 Global Market Size 8.1 OTC/DTC ID Global Market Size by Country 8.2 OTC/DTC ID Global Market Size by Syndrome 8.3 OTC/DTC ID Global Market Size by Channel 9 Global Market by Syndrome 9.1 Respiratory Market 9.2 STD Market 9.3 UTI Market 9.4 HxV Market 9.5 Other Market 10 Global Market by Channel 10.1 OTC Market 10.2 DTC Market 10.3 HSG Market 11 Appendices 11.1 Growth of Approved IVD Test Menu 11.2 Growth of Approved Average IVD Test Fee 11.3 The Most Used IVD Assays 11.4 The Highest Grossing Assays 11.5 Laboratory Fees Schedule For more information about this report visit https://www.researchandmarkets.com/r/qemc4i About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.