Pathology

Proposed FDA Regulatory Flexibilities Permit Primary Diagnosis with Inspirata’s Dynamyx Digital Pathology Solution

Thursday, January 21, 2021 - 8:58pm

Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspiratas digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.

Key Points: 
  • Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspiratas digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.
  • While Inspirata has been in the process of obtaining 510(k) clearance from the FDA, the temporary waiver has allowed Dynamyx to be used for primary diagnosis since the waivers issuance in 2020.
  • However, the newly proposed permanent waiver would allow Dynamyx to be used for primary diagnosis in perpetuity without the need of a 510(k).
  • In fact, Digital Pathology Image Viewing and Management Software registered zero adverse effects during that time.

Aiforia partners with Pathan to bring artificial intelligence assisted diagnostics to the pathology lab

Thursday, January 21, 2021 - 2:30pm

BOSTON, Jan. 21, 2021 /PRNewswire/ -- Pathan, one of the largest pathology laboratories in the Netherlands, has started a collaboration with Aiforia, a leading software company providing artificial intelligence (AI) solutions for medical image analysis.

Key Points: 
  • BOSTON, Jan. 21, 2021 /PRNewswire/ -- Pathan, one of the largest pathology laboratories in the Netherlands, has started a collaboration with Aiforia, a leading software company providing artificial intelligence (AI) solutions for medical image analysis.
  • Meanwhile the methods these healthcare professionals currently rely on are manual, sometimes time-consuming, and subject to a certain degree of bias.
  • After adopting digital pathology in their lab to digitize their analysis, they are ready to add artificial intelligence to this workflow to optimize their output.
  • Artificial intelligence excels at image analysis, with the potential to surpass human capabilities in speed and accuracy.

Amsterdam UMC adds digital pathology to its existing Sectra solution to enable integrated diagnostics for better cancer care

Thursday, January 21, 2021 - 7:50am

With radiology and pathology in one joint solution, Amsterdam UMC will be able to conveniently share images and information between the two medical specialties, enabling efficient integrated diagnostics and improved patient-centric care.

Key Points: 
  • With radiology and pathology in one joint solution, Amsterdam UMC will be able to conveniently share images and information between the two medical specialties, enabling efficient integrated diagnostics and improved patient-centric care.
  • "It's exciting to see how Amsterdam UMC, in just a short time, has taken these steps toward radiology and pathology efficiency, regional collaboration and integrated diagnostics.
  • One of the main benefits of digitizing pathology is the ability to share digital images, rather than sending physical slides back and forth.
  • Sectra's digital pathology solution will be integrated with the laboratory information system (LIS) used at Amsterdam UMC.

Inotiv Broadens Pathology Service Offerings

Tuesday, January 19, 2021 - 1:33pm

WEST LAFAYETTE, Ind., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Bioanalytical Systems, Inc. (NASDAQ:BASI) (BASi, the Company, We, Our or Inotiv), doing business as Inotiv, a leading provider of nonclinical and analytical contract research services, today announced the most recent hiring related to the continued expansion of the Companys pathology service offerings through ongoing investment and key hires.

Key Points: 
  • WEST LAFAYETTE, Ind., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Bioanalytical Systems, Inc. (NASDAQ:BASI) (BASi, the Company, We, Our or Inotiv), doing business as Inotiv, a leading provider of nonclinical and analytical contract research services, today announced the most recent hiring related to the continued expansion of the Companys pathology service offerings through ongoing investment and key hires.
  • Effective January 18, 2021, Adam Aulbach, DVM, DACVP, joined the Company as Director, Clinical Pathology.
  • We assess the needs of our clients on an ongoing basis and respond by enhancing our offerings, said Dr. Stewart Jacobson, Senior Vice President, Pathology.
  • The ability to provide expertise in veterinary clinical pathology, and to integrate that expertise with our already strong anatomic pathology service, should create even greater value for our clients.

Canadian Pathology Quality Assurance Leverages Diaceutics’ DXRX Platform to Advance NTRK IHC Proficiency Testing

Monday, January 18, 2021 - 3:05pm

Diaceutics PLC , (AIM: DXRX), today announces a strategic partnership with Canadian Pathology Quality Assurance (CPQA) to advance the development of Neurotrophic Tropomyosin Receptor Kinase (NTRK) IHC proficiency testing globally.

Key Points: 
  • Diaceutics PLC , (AIM: DXRX), today announces a strategic partnership with Canadian Pathology Quality Assurance (CPQA) to advance the development of Neurotrophic Tropomyosin Receptor Kinase (NTRK) IHC proficiency testing globally.
  • Globally, more labs are now testing for NTRK which means there is a growing demand for a robust Proficiency Testing (PT) program in this area.
  • CPQA has identified the need to source Formalin-Fixed Paraffin-Embedded (FFPE) tissue blocks from laboratories to enable them to build a small tissue microarray for the purposes of NTRK IHC proficiency testing and the development of NTRK IHC validation assistance.
  • John Garratt, Director, CPQA said: We are looking forward to taking advantage of Diaceutics extensive network facilitated through DXRX.

Anatomic Pathology Testing Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2026 - ResearchAndMarkets.com

Friday, January 15, 2021 - 12:03pm

The "Anatomic Pathology Testing Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Anatomic Pathology Testing Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2026" report has been added to ResearchAndMarkets.com's offering.
  • The report on the global anatomic pathology testing market provides qualitative and quantitative analysis for the period from 2018 to 2026.
  • The report on anatomic pathology testing market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global anatomic pathology testing market over the period of 2018 to 2026.
  • Complete coverage of all the segments in the anatomic pathology testing market to analyze the trends, developments in the global market and forecast of market size up to 2026.

Nucleai and Debiopharm Launch Research Collaboration Utilizing Nucleai's Ai-Powered Biomarker Platform

Thursday, January 14, 2021 - 1:38pm

To develop their platform, Nucleai leverages proprietary datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in Israel and the United States.

Key Points: 
  • To develop their platform, Nucleai leverages proprietary datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in Israel and the United States.
  • Debiopharm has multiple therapeutic development programs in oncology that may benefit from this digital pathology biomarker and imaging platform, enabling better patient selection and improved clinical performance.
  • Nucleai is a global provider of AI-powered pathology-based biomarker discovery that transforms the way pathology data is used throughout the research and development of novel therapies.
  • Nucleai works with leading pharmaceutical companies, licensing its research platform for internal use, and collaborating in biomarkers discovery projects.

Paige Announces Series C Funding Round of $100 Million to Accelerate Transformation of Digital Pathology

Thursday, January 14, 2021 - 12:00pm

Paige , a global leader in AI-based digital diagnostics, today announced a Series C funding round of $100 million to accelerate the Companys efforts to transform digital pathology by unlocking insights from each patients sample so pathologists, care teams and researchers can make decisions more confidently and efficiently to optimize outcomes.

Key Points: 
  • Paige , a global leader in AI-based digital diagnostics, today announced a Series C funding round of $100 million to accelerate the Companys efforts to transform digital pathology by unlocking insights from each patients sample so pathologists, care teams and researchers can make decisions more confidently and efficiently to optimize outcomes.
  • The Series C financing was led by Casdin Capital and Johnson & Johnson Innovation JJDC, Inc. (JJDC), the strategic venture capital arm of Johnson & Johnson.
  • Paige is building a transformational portfolio of computational pathology products to serve clinical needs and drive precision medicine, said Leo Grady, Ph.D., Chief Executive Officer, Paige.
  • This investment reaffirms the vast potential of the Paige platform for clinical and biopharmaceutical drug development applications.

Healthcare region pioneering digital pathology reviews in Denmark with Sectra--aims to significantly shorten cancer turn-around times

Thursday, January 14, 2021 - 7:50am

For the Region of Southern Denmark to move to full-scale digital pathology is a milestone for cancer care in Denmark as it is key to meeting the ambitions for shorter lead times set by the national cancer care pathways," says Sune Henriksen, President, Sectra Denmark.

Key Points: 
  • For the Region of Southern Denmark to move to full-scale digital pathology is a milestone for cancer care in Denmark as it is key to meeting the ambitions for shorter lead times set by the national cancer care pathways," says Sune Henriksen, President, Sectra Denmark.
  • The Region of Southern Denmark is the first Danish healthcare region to digitize pathology in full scale.
  • With Sectra's digital pathology solution, resource utilization and sub-specialization can be optimized at the region's four geographically dispersed hospitals.
  • This enables the region to provide all patients with equal access to healthcare services, regardless of their location.

Heska Corporation to Acquire Lacuna Diagnostics, a Pioneer and Market Leader in Point-of-Care Digital Cytology

Wednesday, January 13, 2021 - 1:00pm

Lacuna improves veterinarian accuracy and confidence and accelerates positive healthcare outcomes by dramatically decreasing the wait times and environmental pollution associated with traditional central reference lab pathology services.

Key Points: 
  • Lacuna improves veterinarian accuracy and confidence and accelerates positive healthcare outcomes by dramatically decreasing the wait times and environmental pollution associated with traditional central reference lab pathology services.
  • "We are excited to welcome the wonderful leadership, people, and culture of Lacuna," continued Mr. Wilson.
  • "Lacuna has created a foundation of amazing technology, processes, and expert clinical teams to deliver specialist-level diagnostics, in minutes rather than days.
  • Heska Corporation (NASDAQ: HSKA) manufactures, develops and sells advanced veterinary diagnostic and specialty healthcare products through its two business segments: North America and International.