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Impact of the In-Vitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024 Report - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 5, 2024

The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.
  • In Vitro Diagnostic (IVD) tests are critical to clinical trial operations, serving to help select patients in clinical trials, provide accurate efficacy results, monitor patient response, and more.
  • As a result, current and pending drug clinical trials utilizing IVD tests now must also adhere to the IVDR.
  • However, this process is currently complex and uncoordinated, resulting in delays in clinical trials and patients waiting longer to participate in clinical trials, or even not participating at all.

Veracyte Announces Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Thursday, February 22, 2024

Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.
  • “We closed 2023 with another quarter of excellent results, driven by our Afirma and Decipher businesses,” said Marc Stapley, Veracyte’s chief executive officer.
  • Total revenue for the fourth quarter of 2023 was $98.2 million, an increase of 22% compared to $80.3 million reported in the fourth quarter of 2022.
  • Total gross margin for the fourth quarter of 2023, including the amortization of acquired intangible assets, was 66%, compared to 61% in the fourth quarter of 2022.

Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for Influenza Multiplex PCR Test

Retrieved on: 
Thursday, March 7, 2024

SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic ("IVD") for the detection and differentiation of Influenza A and Influenza B.

Key Points: 
  • Co-Primers utilize a unique design architecture to combat common issues with real-time PCR that can lead to inaccurate results, specifically primer dimer propagation, and which are magnified in multiplex reactions.
  • "The importance of accurate, reliable PCR testing at the high-throughput clinical laboratory level remains critical," remarked Dwight Egan, CEO of Co-Diagnostics.
  • *The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
  • The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

Lab Community "Extremely Concerned" About Patient Access to Testing If FDA Regulates Lab-Developed Tests

Retrieved on: 
Tuesday, March 5, 2024

"If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."

Key Points: 
  • "If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."
  • To better understand how clinical laboratorians perceive the proposed rule, ARUP Laboratories conducted a survey of the clinical laboratory community.
  • Most respondents identified themselves as lab managers, lab supervisors, lab directors, lab employees, medical directors, pathologists, physicians, clinicians, or PhD scientists.
  • Over a hundred thousand clinical laboratorians dedicate their professional lives to ensuring high-quality testing and patient care every day in the U.S.

Parks Associates: 61% of Households Who Churned from a Video Streaming Service Think They Are Spending Too Much on Streaming Services

Retrieved on: 
Tuesday, February 20, 2024

DALLAS, Feb. 20, 2024 /PRNewswire/ -- Parks Associates' just-published consumer study, The Viewer Journey: Navigating Streaming Options, finds churn remains a persistent problem for video streaming services, with cost and trouble finding content the leading drivers. Among the 48% of US internet households that cancelled a streaming video service in the past 12 months, 61% feel they are spending too much on these services. Fifty-seven percent admit switching between services when they can't find anything to watch, while 50% expressed frustration when a favorite show is cancelled or removed from a service.

Key Points: 
  • Among the 48% of US internet households that cancelled a streaming video service in the past 12 months, 61% feel they are spending too much on these services.
  • "But consumers are not excited by the many service choices—more than half of households who recently churned feel there are too many streaming options to choose from.
  • Parks Associates' data from Q3 2023 show that households subscribe to 5.8 services on average, while 29% subscribe to more than eight.
  • The Viewer Journey: Navigating Streaming Options examines the viewer journey for accessing desired video content across broadcast, traditional pay-TV, and the many over-the-top (OTT) streaming video service models, including SVOD, AVOD/FAST, TVOD and vMVPD (streaming TV) services.

WTW enters co-brokerage agreement with the Solomon Agency Corporation

Retrieved on: 
Monday, February 12, 2024

NEW YORK, Feb. 12, 2024 (GLOBE NEWSWIRE) -- WTW (NASDAQ: WTW), a leading global advisory, broking, and solutions company, today announced a co-brokerage arrangement with the Solomon Agency Corporation.

Key Points: 
  • NEW YORK, Feb. 12, 2024 (GLOBE NEWSWIRE) -- WTW (NASDAQ: WTW), a leading global advisory, broking, and solutions company, today announced a co-brokerage arrangement with the Solomon Agency Corporation.
  • With the extensive brokerage experience that WTW’s Asia Risk Division brings to relationship, the Asian clients that Solomon Agency Corporation brings to the engagement will benefit from the market relationships that WTW maintains throughout the industry.
  • I am proud to continue investing in our Asian expansion strategy, and this alliance with the Solomon Agency Corporation is a clear demonstration of our investment in Asia.
  • This co-brokerage agreement reinforces WTW’s commitment to Asia within the US marketplace, initiated with the creation of the Asia Risk Division in July of 2023.”

Parks Associates: 46% of Pay-TV Subscribers Are Interested in the Ability to Control Smart Home and Security Solutions Through Their TV Service

Retrieved on: 
Tuesday, February 6, 2024

DALLAS, Feb. 6, 2024 /PRNewswire/ -- Parks Associates' research in Video Services: Shifting Demand reveals 46% of pay-TV subscribers find emerging home control and interactive features, provided through their TV service, appealing or very appealing. The consumer study of 8,000 US internet households provides a comprehensive view of the traditional pay-TV, streaming TV, and OTT services market across business models, with data and insight on strategies to enhance the viewer experience and reduce churn.

Key Points: 
  • "This data highlights a significant interest in smart home technology integration within the pay-TV market," said Elizabeth Parks , President and CMO, Parks Associates.
  • "The home ecosystems continue to overlap, creating new opportunities to expand control and enhance the user experience.
  • It also details top causes of service churn and consumer receptivity to new service features and retention incentives.
  • Appeal is high particularly among households with a security service—65% find home control through their pay-TV service appealing.

Altium 365 Integrates with Z2Data To Deliver Comprehensive Component Data and Risk Management Solution

Retrieved on: 
Tuesday, January 9, 2024

Altium, LLC (ASX: ALU), a leader in global electronics development software, today announced its integration with Z2Data, one of the most comprehensive electronics supply chain risk management solutions.

Key Points: 
  • Altium, LLC (ASX: ALU), a leader in global electronics development software, today announced its integration with Z2Data, one of the most comprehensive electronics supply chain risk management solutions.
  • View the full release here: https://www.businesswire.com/news/home/20240109568987/en/
    Introducing Z2Data Integration in Altium 365 (Graphic: Business Wire)
    This integration will provide Altium 365 users with direct access to Z2Data’s extensive supply chain and component database, enabling them to build resilience in engineering, compliance, and procurement.
  • Drawing upon Z2Data’s broad database of over a billion electronic components, Altium 365 users will have access to detailed component information, spanning everything from basic resistors to sophisticated integrated circuits.
  • This data gathered directly from manufacturers, ensures accuracy and reliability, providing one platform for engineers and procurement professionals to manage supply chain risk.

AiDot Showcases Complete Smart Living Solutions at CES 2024 Propelling Offline Retail Expansion

Retrieved on: 
Thursday, January 11, 2024

LAS VEGAS, Jan. 11, 2024 /PRNewswire/ -- AiDot , the innovator in smart living technology, captivated audiences at the Consumer Electronics Show (CES) 2024 by unveiling a stunning array of real-life scenarios powered by their cutting-edge AiDot smart living solutions.

Key Points: 
  • LAS VEGAS, Jan. 11, 2024 /PRNewswire/ -- AiDot , the innovator in smart living technology, captivated audiences at the Consumer Electronics Show (CES) 2024 by unveiling a stunning array of real-life scenarios powered by their cutting-edge AiDot smart living solutions.
  • Through immersive experiences, attendees saw firsthand how AiDot's products are transforming living spaces, as well as gaining insight into convenient, efficient and sustainable smart home solutions.
  • "We're excited to showcase AiDot's smart living technologies at CES 2024 by setting up real-life scenarios," stated Luke Lin, CEO of AiDot.
  • As CES 2024 draws to a close, AiDot continues to drive innovation and accessibility in the smart living landscape, pioneering a future where technology seamlessly enriches human experiences.

Community Access Celebrates Graduation of Howie the Harp Peer Workforce Training Participants

Retrieved on: 
Wednesday, January 10, 2024

NEW YORK, Jan. 10, 2024 /PRNewswire/ -- On Monday, January 8, the mental health nonprofit Community Access celebrated graduates of its Howie the Harp Peer Workforce training program at a moving ceremony featuring families, friends, and supporters. It was the organization's first in-person celebration of graduates since 2019.

Key Points: 
  • Founded in 1995, the award-winning Community Access Howie the Harp Peer Training Program equips individuals with a lived experience in the mental health system for direct service, supervisory, and management roles within the human services sector.
  • "Community Access knows that in order to transform the mental health system, we need to transform its workforce.
  • We look forward to expanding Howie the Harp to further strengthen the human services workforce in the years to come."
  • The Community Access Howie the Harp Peer Training Program is the oldest peer training program in the United States.