Karius, Inc.

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.

RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced the appointment of Norman E. “Ned” Sharpless, MD, to the Company’s Board of Directors as an independent director. Dr. Sharpless is a physician, scientist and entrepreneur who has led tremendous progress in cancer research and care serving in several leadership roles, including Director of the National Cancer Institute (NCI) and Acting Commissioner of the US Food and Drug Administration (FDA). “We’re thrilled to welcome Ned, a distinguished oncologist, accomplished scientist and seasoned public servant, to our Board of Directors,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “Ned brings unparalleled oncology expertise and experience to our Board at this important point in our growth. Ned’s passion and commitment to innovating cancer care and scientific prowess, particularly in cell cycle biology, will be invaluable as we race to bring INX-315 to patients.” “I have dedicated my career to improving the lives of people affected by cancer,” said Dr. Sharpless. “Incyclix has made exciting progress investigating the potential of its CDK2 inhibitor, INX-315, to provide treatment for patients with advanced and resistant cancer. I look forward to working with Incyclix’s experienced board and leadership team to bring this important novel treatment option to patients in need.” Dr. Sharpless is a physician, scientist, entrepreneur and former federal official, serving as Director of the National Cancer Institute from 2017 to 2022, and as Acting Commissioner of the FDA in 2019. As a federal official, he led multiple research initiatives spanning cellular immunotherapy, early cancer detection, global oncology and the use of artificial intelligence and machine learning to improve outcomes for patients affected by cancer. Prior to government, Dr. Sharpless was the Wellcome Distinguished Professor of Medicine and Director of the Lineberger Comprehensive Cancer Center at the University of North Carolina (UNC) School of Medicine. He is on the boards Karius Inc., Nucleus Radiopharma, the Eshelman Institute for Innovation, the CEO Roundtable on Cancer and the American Cancer Society; and is the co-Founder and Managing Director of Jupiter BioVentures. He was founder and board member of G1 Therapeutics, which developed the FDA-approved medicine Cosela (Trilaciclib), used to prevent chemotherapy toxicity. He is the Professor of Cancer Policy and Innovation at the UNC School of Medicine, and is a member of the American Association for Cancer Research Academy, the Association of American Physicians, the American Society for Clinical Investigation and the National Academy of Medicine. He received an MD from the UNC School of Medicine, followed by an internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at the Dana-Farber/Partners Cancer Care, both of Harvard Medical School. About Incyclix Bio Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com. Media ContactTony Plohoros908-591-2839tplohoros@6degreespr.com

“[Tempus'] IPO was an important test of investor appetite for precision medicine, a sector that has seen a wide range of startups emerge over the past half-decade,” PitchBook analysts wrote.  Medtech startups fared well in the second quarter with investment activity on track to surpass last year and venture capital exits are on the rise, according to PitchBook's latest sector report.It's the latest sign that the medtech sector may be through its recent dry spell.Medtech venture capital investment held steady in Q2 with $3.3 billion of deal value, down slightly from the $3.5 billion of activity in the first quarter, according to the report. The $3.3 billion in total deal value marks a 7% decline from Q1 but a 3.2% gain year over year. This marks the second straight quarter of higher deal activity compared with the prior-year period. Through the first half of 2024, medtech VC investment, at $6.8 billion, surpassed last year, and funding for the full year is on track to be close to 20% higher compared with 2023. In Q2, there were 206 total deals, down 3.3% quarter over quarter and down 13.4% year over year. "Despite quarterly variability, the current level of VC investment is a positive sign for the medtech VC landscape and lends credence to the view that the market has passed through the trough of investment activity," PitchBook analysts reported.After several quarters of minimal exit activity, the story shifted in Q2 with several VC-backed startups having an exit outcome. VC exits reached $6.6 billion in the first half of the year, driven mainly by Tempus’ initial public offering, and the first six months of 2024 were higher than medtech exit value for all of 2023. However, PitchBook analysts note that exit value remains well below the levels seen in 2021 and 2022. "Given the unique market dynamics during the height of the COVID-19 pandemic, and considering current conditions, we view VC exit levels in medtech for 2024 so far as a solid win for the sector and a positive sign for deal value and exit momentum going forward," PitchBook analysts wrote in the report. The report called out notable deals from Q2. Insightec raised $150 million, one of the largest VC transactions in the quarter, and BillionToOne raised $130 million in a series D round. Kardium, Karius, and Delfi Diagnostics announced VC deals above $100 million during the quarter. Illumina completed its divestment of GRAIL, which is now trading as a public company under the ticker symbol “GRAL.” Illumina is maintaining 14.5% of GRAIL’s shares. Several large acquisitions also happened in Q2. Johnson & Johnson acquired ShockWave Medical for $13.1 billion. Boston Scientific acquired Silk Road Medical for $1.2 billion. Tempus AI’s IPO is rallying hope for the medtech industry after it went public in June and raised $400 million, though the company was not profitable.“The IPO was an important test of investor appetite for precision medicine, a sector that has seen a wide range of startups emerge over the past half-decade,” PitchBook analysts wrote. PitchBook also noted that the Tempus AI’s public listing could raise the chances that unprofitable companies score investments, if there’s a route to an IPO.The most active VC investors in medtech in Q2 were the European Innovation Council Fund, SOSV, Alumni Ventures and Arboretum Ventures, according to PitchBook.There were 28 PE buyouts in the sector and 19 PE growth deals, the report says.