Contact us

    MrMrsMsDr



    Collection and Use of Personal Information. *

    Deep Bio and Visiopharm Announce a Collaborative Integration of a Clinical-Grade AI Prostate Cancer Solution with a Leading Digital Pathology Platform

    Pathologists can now have access to the state-of-the-art AI prostate cancer grading solution     
                               
    SEOUL, SOUTH KOREA (PRWEB) NOVEMBER 15, 2022 – Deep Bio, a leading AI biotech dedicated to cancer diagnosis, and Visiopharm, a world leader in AI-powered image analysis and tissue mining for research and diagnostics, announced a strategic partnership to provide pathologists access to the latest AI-powered prostate cancer solution.

    AI-powered cancer diagnostics has been proving its utility not only in research, but increasingly in supporting and improving pathologists’ decisions, workflow efficiency, and diagnostic precision. Deep Bio’s deep learning-based CE-IVDD prostate cancer diagnosis support software, DeepDx® Prostate, empowers pathologists by identifying cancerous areas and grading their severity providing a Gleason scoring.

    With this collaboration, DeepDx® strengthens Visiopharm’s diagnostic offering to its European diagnostic customers. This application expands pathologists’ accessibility to the latest cutting-edge H&E-based AI solutions for prostate cancer, which today is a large diagnostic indication that is both time and labor-intensive in diagnostic pathology labs. With its extensive AI-based image analysis solutions for multiple cancer types, Visiopharm’s platform is contributing to the global adoption of digital pathology and AI.

    The first phase of integration of DeepDx® into Visiopharm’s digital pathology platform has been completed. In the next phases, Visiopharm will together with Deep Bio scale up the solution as interest grows. The two companies plan to add additional AI cancer pathology solutions over time for prostate and breast, among others.

    “Digital transformation in healthcare is not a new concept anymore. Pathology, which has been slow to undergo digital transformation, is fast becoming digitalized due to a diverse range of AI solutions now available for implementation and validation”, said Sun Woo Kim, the CEO of Deep Bio. “Our dedication to AI for digital pathology has taken a major step forward with this collaboration and we are pleased to offer our latest technology to more labs and hospitals across the world through this opportunity. We will continue to support medical professionals to optimize their decisions which ultimately lead to the best patient care,” he added.

    The second phase of integration will aim for tighter interoperability among the platform and AI solutions, helping both companies to better promote and distribute to healthcare institutions around the world.

    Michael Grunkin, CEO of Visiopharm said, “We are seeing a lot of demand for this particular application among both our clinical research- and diagnostic customers and partners. In diagnostic workflows, this APP has the potential to support pathologists in automating time-consuming and repetitive work, while improving turn-around-time and standardization. This partnership with Deep Bio is a good example of how our scanner, LIMS, and PACS agnostic platform allow our users to benefit both from our own apps and best-in-class apps from our growing partner network, to gain access to a full diagnostic menu.”

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit www.deepbio.co.kr.

    About Visiopharm
    Visiopharm® is a world leader in AI-driven precision pathology software. Visiopharm’s pioneering image analysis tools support thousands of scientists, pathologists, and image analysis experts in academic institutions, biopharmaceutical industry, and diagnostic centers. AI-based image analysis and tissue mining tools support research and drug development research worldwide, while CE-IVD APPs support primary diagnostics. With highly advanced and sophisticated artificial intelligence and deep learning, Visiopharm delivers tissue data mining tools, precision results, and workflows. Visiopharm was founded in 2002 and is privately owned. The company operates internationally with over 780 user accounts and countless users in more than 40 countries. The company headquarters are in Denmark’s Medicon Valley, with offices in Sweden, England, Germany, Netherlands, and the United States.

    Deep Bio Acquires ISO 27001 Certification for an Information Security Management System

    Enhanced security and reliability through adherence to globally recognized information security standards 
                 
    SEOUL, SOUTH KOREA (PRWEB) OCTOBER 27, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics support software, announced that it has acquired ISO/IEC 27001:2013 certification, the international information security management system standards.

    ISO/IEC 27001:2013 specifies the requirements for establishing, implementing, maintaining, and improving an information security management system and provides a risk management process so that organizations can accordingly keep their information safe. As the most widely-recognized certification for information security management, it strictly evaluates 144 criteria in 14 categories such as information security policy, security processes, security controls and services. By obtaining the certification, Deep Bio has demonstrated its commitment to protecting data through systematic management for information security.

    “As we handle a myriad of medical data which require a more secure approach, we are very aware of the importance of information security above all else, and make every effort to build a thorough security management system,” said Sun Woo Kim, the CEO of Deep Bio. “Achieving the certification proves our robust data security management systems. We will keep renewing this certification so that our partners and customers can use our AI-based cancer diagnostic support software with confidence,” he mentioned.

    Deep Bio, which initiated AI-based pathology image analysis and cancer diagnosis research in Korea, is leading the digital transformation in pathology with Korea’s first approved AI-based cancer diagnostic support software DeepDx®-Prostate and AI-based prostate cancer severity-grading software DeepDx®-Prostate Pro. More importantly, the company plans to execute purchase agreements with five Korean hospitals for DeepDx®-Prostate Pro, through the Public Procurement Marketplace program run by the Korean Public Procurement Service (PPS).

    Deep Bio also continues to build its global presence through overseas partnerships with digital pathology platform providers in the US, Europe, and India, as well as conduct research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US. The company also has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, among others.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit www.deepbio.co.kr.

    Deep Bio Selected as ‘Korea AI Startup 100’ for Two Consecutive Years

    AI experts expect Deep Bio to succeed in the healthcare industry with its innovative technology

    SEOUL, SOUTH KOREA (PRWEB) OCTOBER 21, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics support software, announced that it has been selected as one of the promising AI startups in the ‘Korea AI Startup 100’ list for the second time in a row.

    ‘Korea AI Startup 100’, an annual accelerator project cohosted by the Korea Economic Daily and AI One Team, an Industry-University-Research Council, discovers promising Korean AI startups. The project aims to support companies to strengthen their market presence and build their capability, thus enhancing national AI competitiveness in the global market as well as boosting the establishment of the startup ecosystem.

    To choose the most notable 100 startups, a committee made up of AI experts evaluated candidates based on criteria that the Korea Advanced Institute of Science and Technology (KAIST) and KT Economics & Management Research Institute developed. The applicants were assessed on both quantitative factors such as market growth potential, corporate value, competitiveness in the AI technology space, and qualitative aspects including corporate sustainability.

    After three rounds of evaluation, Deep Bio was selected as one of the finalists of the Korea AI Startup 100 in the healthcare industry. “It is a great honor to be designated as a promising startup that represents Korea. This opportunity once again becomes motivation for our company to advance our AI capability that can contribute to the society,” said Sun Woo Kim, the CEO of Deep Bio. He also added, “with our innovative deep learning technology, we will strive to lead the digitalization of medical care.”

    Deep Bio, which initiated AI-based pathology image analysis and cancer diagnosis research in Korea, is leading the digital transformation in pathology with Korea’s first approved AI-based cancer diagnostic support software DeepDx®-Prostate and AI-based prostate cancer severity-grading software DeepDx®-Prostate Pro. More importantly, the company plans to execute l purchase agreements with five Korean hospitals for DeepDx®-Prostate Pro, through the Public Procurement Marketplace program run by the Korean Public Procurement Service (PPS).

    Deep Bio also continues to build its global presence through overseas partnerships with digital pathology platform providers in the US, Europe, and India, as well as conduct research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US. The company also has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, among others.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit www.deepbio.co.kr.

    Deep Bio Welcomes New Advisors to Accelerate Its Growth in Global Market

    The new advisors will focus on Deep Bio’s overseas business expansion as well as strengthening its expertise in cancer pathology.                                   

    SEOUL, SOUTH KOREA (PRWEB) OCTOBER 10, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics support software, announced that it has appointed professionals in pathology and precision medicine as advisors to reinforce its cancer pathology expertise and accelerate its overseas business growth.

    This month, a pathologist Dr. Michael Bonham (MD, Ph.D.) joined Deep Bio as a new advisor. With renowned expertise in both pathology and med-tech innovations, Dr. Bonham is expected to provide valuable insights and support for the company’s strategic partnerships and R&D with other digital pathology companies as well as research institutes. Before joining Deep Bio, he built up extensive experience working at many renowned bio companies and pathology laboratories including Genomic Health. In particular, as a former Chief Medical Officer (CMO) of Proscia, a US digital pathology platform provider, he led the success in the development and marketing of AI-based cancer diagnosis support solutions and platforms.

    “I decided to join the Deep Bio team because of their commitment to bringing radical changes to the diagnostic field of pathology by applying their state-of-the-art technology towards laboratory automation and diagnostic quality, thereby improving patient care around the world,” said Dr. Bonham. “Pathology is undergoing an incredible digital transformation that will help shape the next generation of precision medicine, Deep Bio is well positioned to become a leader in this space,” he added.

    Deep Bio also welcomed a precision medicine expert to its advisory board. Dr. Kamala Maddali (DVM, Ph.D.), the founder and CEO of Health Collaborations, a consulting firm specializing in AI-based precision medicine, is expected to provide insights and support for research collaborations for biomarker discovery in the life sciences sector. Since she started her career at Merck & Co. Dr. Maddali has achieved great accomplishments in her 17 years-plus experience in precision medicine, oncology, and business.

    “With its AI-driven insights in pathology, Deep Bio has the unique potential for fostering precise data-driven cancer diagnostics to help better clinical care and precision drug development,” said Dr. Maddali. “I am thrilled to join this promising team and support their great mission to provide total cancer care with the power of AI.”

    Sun-Woo Kim, CEO of Deep Bio said “as the digital pathology and AI market continues to grow globally, Deep Bio has continued to build sales channels around the world. With the remarkable advisors now joining Deep Bio, we will strive to establish our presence in the global market and bring innovative products to the industry.”

    Deep Bio, which initiated AI-based pathology image analysis and cancer diagnosis research in Korea, continues to build its global presence through overseas digital pathology platform providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US. The company also has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, among others.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.

    Deep Bio’s AI Support for Prostate Cancer Diagnosis will be Deployed at Five Korean Hospitals

    DeepDx®-Prostate Pro, designated as an Innovative Product by the Korea Public Procurement Service, is expected to improve pathology workflows in real clinical settings

    SEOUL, SOUTH KOREA (PRWEB) OCTOBER 10, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics software, announced that it will sign trial purchase agreements with five Korean hospitals for its AI-based prostate cancer diagnosis support software, DeepDx®-Prostate Pro, through the Public Procurement Marketplace program run by the Korean Public Procurement Service (PPS). The software was designated as an ‘Innovative Product’ in July 2022.

    To successfully complete the integration of DeepDx®-Prostate Pro into the pathology workflows by this November, the hospitals participating in the trial purchase – the SMG-SNU Boramae Medical Center, Chungnam National University Sejong Hospital, Korea Institute of Radiological & Medical Sciences, Jeju National University Hospital, and Gyeongsang National University Changwon Hospital – and Deep Bio are progressing through required procedures and making arrangements. The AI will be used for various purposes, including support for pathologists in tumor severity determination, confirmation of diagnoses, and research.

    DeepDx®-Prostate Pro is a deep learning-based medical software that assists the histopathological diagnosis of prostate cancer by analyzing the Whole Slide Image (WSI) of the prostate needle biopsies. It automatically classifies the severity of prostate cancer, which empowers pathologists to make diagnostic decisions with increased accuracy and speed.

    “We are greatly expecting to prove that our software can be seamlessly integrated into the current pathology workflows, bringing positive changes such as reducing pathologists’ work burden and improving efficiency in real clinical settings,” mentioned Sun-Woo Kim, CEO of Deep Bio. He also said, “through this trial purchase project, Deep Bio will lead the introduction of digital pathology in Korea as well as accelerate domestic market expansion.”

    Korea PPS’ ‘Innovative Product Designation Program’ is a government program that aims to foster the development of innovative technologies. To select Innovative Products, a committee made up of the Korea PPS and experts in each field, such as bio-health, future automobiles, and carbon neutrality, evaluates each registrant based on several criteria including public value and innovation.

    Focusing not only on AI diagnostics but also R&D, Deep Bio has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, as well as in various international conferences and events. The company also continues to build its global presence through overseas digital pathology platform providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.

    [ARTICLE] Modern Pathology – Artificial intelligence system shows performance at the level of uropathologists for the detection and grading of prostate cancer in core needle biopsy: an independent ext…

    MODERN PATHOLOGY

    ARTICLE | VOLUME 35, ISSUE 10, P1449-1457, OCTOBER 2022

    Authors: Minsun Jung, Min-Sun Jin, Chungyeul Kim, Cheol Lee, Ilias P. Nikas, Jeong Hwan Park, Han Suk Ryu

    Abstract

    Accurate diagnosis and grading of needle biopsies are crucial for prostate cancer management. A uropathologist-level artificial intelligence (AI) system could help make unbiased decisions and improve pathologists’ efficiency. We previously reported an artificial neural network-based, automated, diagnostic software for prostate biopsy, DeepDx® Prostate (DeepDx). Using an independent external dataset, we aimed to validate the performance of DeepDx at the levels of prostate cancer diagnosis and grading and evaluate its potential value to the general pathologist. A dataset composed of 593 whole-slide images of prostate biopsies (130 normal and 463 adenocarcinomas) was assembled, including their original pathology reports. The Gleason scores (GSs) and grade groups (GGs) determined by three uropathology experts were considered as the reference standard. A general pathologist conducted user validation by scoring the dataset with and without AI assistance. DeepDx was accurate for prostate cancer detection at a similar level to the original pathology report, whereas it was more concordant than the latter with the reference GGs and GSs (kappa/quadratic-weighted kappa = 0.713/0.922 vs. 0.619/0.873 for GGs and 0.654/0.904 vs. 0.576/0.858 for GSs). Notably, it outperformed the original report, especially in the detection of Gleason patterns 4/5, and achieved excellent agreement in quantifying the Gleason pattern 4. When the general pathologist used AI assistance, the concordance of GG between the user and the reference standard increased (kappa/quadratic-weighted kappa, 0.621/0.876 to 0.741/0.925), while the average slide examination time was substantially decreased (55.7 to 36.8 s/case). Overall, DeepDx was capable of making expert-level diagnosis in prostate core biopsies. In addition, its remarkable performance in detecting high-grade Gleason patterns and enhancing the general pathologist’s diagnostic performance supports its potential value in routine practice.

    Link to the Article: Click Here

    Deep Bio Acquires MDSAP Certification, Paving the Way for Global Expansion

    Demonstrated globally-recognized standards in safety and quality management as a medical software manufacturer.

    SEOUL, SOUTH KOREA (PRWEB) AUGUST 16, 2022 – Deep Bio, a pioneer in medical AI for pathologic cancer diagnostics, announced that it has been recently granted Medical Device Single Audit Program (MDSAP) certificate.

    MDSAP is a unified global regulatory audit of medical device manufacturing operated by the International Medical Device Regulators Forum (IMDRF). MDSAP-certified manufacturers are considered to have satisfied the relevant requirements of the regulatory authorities participating in the program including the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).

    Through the MDSAP certificate, Deep Bio demonstrated its commitment to high product quality standards and safety management. Also, it is expected that Deep Bio will be able to enter the US, Canada, Japan, Australia, and Brazil markets faster and more efficiently in the future, saving time and cost associated with Quality Management System (QMS) in each market.

    “Obtaining MDSAP certification is meaningful in that our products are recognized for outstanding quality management on top of innovative technology in the global market,” said Sun Woo Kim, CEO of Deep Bio. “In particular, as these five countries account for more than half of the global medical device market, I am confident that passing the MDSAP audit can be a great opportunity to expand our presence in overseas markets. At the same time, we will make every effort to strengthen our differentiated technology through continuous product research and establish ourselves as a leader in AI-based cancer diagnostics in global markets,” added he.

    Deep Bio continues to focus on not only AI diagnostics but also R&D and presenting the results in various international conferences and events. The company also continues to build its presence in the global market through overseas digital pathology solution providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Center, and other top research institutions in the US.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.

    Deep Bio’s AI Support for Cancer Diagnosis has been Designated as an Innovative Product by the Korean Public Procurement Service

    This designation marks the Korean government’s recognition of innovation for DeepDx®-Prostate Pro.

    SEOUL, SOUTH KOREA (PRWEB) JULY 25, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics software, announced that its AI solution for grading the severity of prostate cancer, DeepDx®-Prostate Pro, has been officially designated as an ‘Innovative Product (Fast Track II)’ by the Korean Public Procurement Service (PPS) in the bio-health sector, a public recognition of product excellence and innovation.

    ‘Innovative Product Designation Program’ is a government program that aims to foster the development of innovative technologies and is operated by the Korean PPS, providing public access to breakthrough technologies. To select Innovative Products, a committee made up of the Korea PPS and experts in each field, such as bio-health, future automobiles, carbon neutrality, evaluate each registrant based on several criteria including public value and innovation. As a result, Deep Bio can now execute a purchase agreement with the PPS, and the product can be registered in the Public Procurement Market.

    With the registration of DeepDx®-Prostate Pro in the Public Procurement Market through this designation, the software as a medical device is now available to more than 300K national- and public institutions for purchase. With this opportunity, Deep Bio is expected to lay the groundwork for market expansion as well as demonstrate the clinical utility of its software.

    “We are delighted that the Korean PPS designated DeepDx®-Prostate Pro as an Innovative Product. It represents an official government recognition of the innovation of our state-of-the-art technology. Through this, potential clients at national- and public institutions can better access Deep Bio’s groundbreaking software for purchase”, said Sun-Woo Kim, CEO of Deep Bio. “We also hope that this will be a great opportunity to confirm the robust performance and value of our software when implemented into real clinical workflows,” added he.

    DeepDx®-Prostate Pro is a deep learning-based medical software that assists the histopathological diagnosis of prostate cancer by analyzing the Whole Slide Image (WSI) of the prostate needle biopsies. It automatically classifies the severity of prostate cancer based on the Gleason grading system, which is the most widely-used method for evaluating the degree of differentiation of prostate cancer tissues. The software has received Korea MFDS (Ministry of Food and Drug Safety) approval as a Class III medical device in November 2021. In a clinical validation study, the analysis by the software showed high concordance with the reference standard established by experienced board-certified pathologists. In addition, the software improved workflows by significantly reducing time spent by pathologists on analysis of each slide. The study results were published in Modern Pathology.

    Focusing not only on AI diagnostics but also on R&D, Deep Bio has been presenting its novel research results in prestigious science and technology journals including the Cancers Journal, npj Digital Medicine, as well as in various international conferences and events. The company also continues to build its global presence through overseas digital pathology solution providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US.

    About Deep Bio

    Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio’s vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.

    Deep Bio’s AI-based Cancer Diagnostic Software Demonstrated Uropathologist-level Performance

    Independent external validation study results of Deep Bio’s AI algorithm for prostate cancer diagnosis were published in the Modern Pathology

     

    SEOUL, SOUTH KOREA (PRWEB) MAY 13, 2022 – Deep Bio, a pioneer in medical AI for digital pathology and cancer diagnostics software, announced that the research results of an external validation study of its deep learning-based prostate cancer diagnostic support software, DeepDx® Prostate, were published in Modern Pathology, demonstrating high concordance to experts.

     

    The study, conducted in collaboration with Seoul National University Hospital (SNUH), aimed to validate the performance of DeepDx® Prostate for detecting and grading prostate cancer and evaluate its clinical value to general pathologists. In the study, 593 hematoxylin and eosin (H&E) stained whole-slide images of prostate biopsies, 130 normal and 463 adenocarcinomas, and their original pathology reports from the Department of Pathology of SNUH were included.

     

    To assess the performance of the algorithm, researchers compared both DeepDx® Prostate analysis results and the original reports against the reference standard established by three uropathology experts. For cancer detection, compared to the original hospital diagnoses, DeepDx® Prostate showed similar sensitivity, NPV and accuracy, and even improvement in specificity and PPV. For Gleason grade group assignments, the algorithm achieved higher concordance (0.713 kappa / 0.922 quadratic-weighted kappa) to the reference standard than the original reports (0.619 kappa / 0.873 quadratic-weighted kappa). Notably, the AI software outperformed the original report in the detection of Gleason patterns 4 and 5, achieving excellent agreement in quantifying areas of Gleason pattern 4.

     

    In addition to performance evaluation, the study also evaluated the utility of the algorithm in a clinical workflow. When a general pathologist evaluated cases with the aid of AI, the concordance of grade group between the user and the reference standard increased (kappa: 0.621 to 0.741 / quadratic-weighted kappa: 0.876 to 0.925), while the average analysis time per case saw a significant reduction from 55.7 to 36.8 seconds, about 34% reduction.

     

    “Accurate grading of prostate cancer biopsies is crucial to guiding disease management and treatment planning. However, pathologists often disagree in their diagnoses,” Jung Minsun, MD, PhD, at Department of Pathology, Yonsei University College of Medicine said. “DeepDx® Prostate can provide value here, by providing consistent results to reduce discrepancies among pathologists, as well as reduce time spent on the reading of the slides, resulting in improved diagnostic accuracy and efficiency at the same time,” added he.

     

    “It is meaningful that DeepDx® Prostate is proven to assist medical professionals at the skill level of uropathologist in cancer detection and grading of severity, which suggests that AI can be a potential screening process when diagnosing prostate cancer,” mentioned Sun-Woo Kim, CEO of Deep Bio. “We will continue to conduct research and develop AI assistance tools for other cancer types until they can be implemented in actual clinical settings.”

     

    Focusing not only on AI diagnostics, but also R&D, Deep Bio has been presenting its novel research results in prestigious science and technology journals including the Cancers, npj Digital Medicine, as well as in various international conferences and events. The company also continues to build its presence in the global market through overseas digital pathology solution providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Institute, and other top research institutions in the US.

     

    About Deep Bio

    Deep Bio Inc. is an AI biotech company with in-house expertise in deep learning, pathology, life sciences, and pharmacotherapeutics. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio envisions a suite of AI-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device) for diagnosis and prognosis of multiple cancers. Deep Bio is actively engaged in the research space and participating in ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr.

    DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores and grade groups. Extensively tested at US CLIA labs (> 500k cores in 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.