Author: Deepbio

Deep Bio renews Research Collaboration Agreement with Dana-Farber Cancer Institute

SEOUL, South Korea, July 22, 2021 – Deep Bio, a leading company in digital pathology and cancer diagnostics, today announced a renewal of their Research Collaboration Agreement with Dana-Farber Cancer Institute aimed at evaluating prostate cancer tumors. This collaboration with Dana-Farber is a part of the Men of African Descent and Carcinoma of the Prostate (MADCaP) Consortium, a global collaboration formed to evaluate the high burden of prostate cancer in the Sub-Saharan African (SSA) population. Dana-Farber is a principal teaching affiliate of Harvard Medical School and the founding member of Dana–Farber/Harvard Cancer Center, the largest National Cancer Institute (NCI) designated Comprehensive Cancer Center in the nation.

This research project will investigate if Deep Bio’s deep learning algorithm, DeepDx® Prostate, can serve as an adjunct to pathologist diagnosis of pathology specimens. Tumor tissue images collected from eight separate centers in Sub-Saharan Africa will be processed and analyzed by DeepDx® Prostate. These AI-based pathology reads will be compared with human pathologist evaluations. This study is led by Dr. Timothy Rebbeck, the Vincent L. Gregory, Jr. Professor of Cancer Prevention at the Harvard TH Chan School of Public Health and Professor of Medical Oncology at the Dana-Farber Cancer Institute.

“We are honored to contribute to the meaningful research at Dana-Farber Cancer Institute, a leading cancer treatment and research center,” said Sun Woo Kim, the CEO and founder of Deep Bio. “This research has clinically significant implications if DeepDx® Prostate shows comparable output to human pathologists. If AI can serve as adjunct to human pathologists, the capacity for cancer diagnosis can improve significantly, particularly in regions such as Sub-Saharan Africa that are facing an extreme shortage of pathologists,” he added.

MADCaP involves 28 centers and over 15,000 men of African descent in North America, the Caribbean, Europe, and Africa to address the global epidemic of prostate cancer in the African diaspora. Prostate cancer has the highest heritability of the common cancers, and men of African descent have a disproportionately high incidence and mortality due to prostate cancer compared to men of other races.

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 MFDS approval of an AI-based cancer pathology 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.

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 group. Extensively tested at a US CLIA lab (>540k cores as of June 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.

2021.07.22
DeepBio

ARUP applies Deep Bio’s deep learning-based prostate cancer detection and classification solution for research

SEOUL, SOUTH KOREA (PRWEB) JULY 16, 2021– Deep Bio, a leading company in AI cancer diagnostics, announced a Research Collaboration Agreement with ARUP Laboratories, a top U.S. reference laboratory and worldwide leader in innovative laboratory research and development. DeepDx® Prostate, Deep Bio’s AI-based prostate cancer diagnosis software, will be used for the joint research.

This is the first of multiple research projects that ARUP and Deep Bio will collaborate on, under the multi-year Research Program. The first project aims to evaluate the impact of DeepDx® Prostate by evaluating whether applying the software in ARUP’s pathology workflow can lead to higher diagnostic performance compared to the current microscope-based diagnosis. For the next project, cancer prognosis-related research is being considered.

“DeepDx® Prostate has been recognized for its exceptional performance and innovative technology both at home and abroad. I am confident that this partnership with the prestigious ARUP Laboratories will bring us closer to the end users as our brand awareness will increase overseas” said Sun Woo Kim, the CEO and founder of Deep Bio. “We will actively endeavor to expand collaborations with top domestic and foreign laboratories to strengthen our position in the global market as well as demonstrate our leadership in AI-based cancer diagnostics,” he added.

“Computer-assisted diagnostic software tools bear enormous promise; however, little is known about their adoption by pathologists,” said Beatrice Knudsen, MD, PhD, ARUP medical director of Digital and Computational Pathology. “The collaboration with Deep Bio will provide important insights into pathologists’ preferences for how to use AI-based software solutions, as well as real life clinical implementation data.”

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 approval of an AI-based cancer pathology 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 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 group. Extensively tested at a US CLIA lab (>500k cores as of June 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 ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide lead in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. ARUP is ISO 15189 CAP accredited.

ARUP Media Contact

Lisa Carricaburu, 801-541-5041, lisa.carricaburu@aruplab.com

2021.07.16
DeepBio

Deep Bio provides its AI-based prostate cancer detection software for research

SEOUL, SOUTH KOREA (PRWEB) JULY 16, 2021 – Deep Bio, a leading company in digital pathology and cancer diagnostics, announced an extension of Software License Agreement with Stanford University School of Medicine. DeepDx® Prostate, Deep Bio’s deep learning-based prostate cancer diagnosis software, is being used in a study conducted by Stanford Medicine researchers on radical prostatectomy specimens.

In the study, the researchers aim to evaluate the diagnostic performance of DeepDx® Prostate by comparing its results with the diagnosis data provided by the researchers. The study also explores the performance of DeepDx® Prostate in patient stratification by clinical use cases to guide therapy. The study results will be published in a peer-reviewed, scientific journal after the research is completed.

“We are proud to collaborate with Stanford Medicine and provide our AI diagnostic software to the research. We are excited that an algorithm such as DeepDx® Prostate which was trained on prostate core needle biopsy samples is being utilized in clinical research on radical prostatectomies,” said Sun Woo Kim, the CEO of Deep Bio. “Through this continued research collaboration, we strive to improve our technology and optimize digital pathology workflows for streamlined cancer diagnosis,” he added.

DeepDx® Prostate analyzes whole slide images (WSIs) of prostate core needle biopsy samples to detect cancer and grade cancer severity based on the Gleason scoring system. DeepDx® Prostate automatically analyzes other critical values such as the area of each Gleason pattern and the total tumor area. Deep Bio plans to expand their suite of AI algorithms to breast cancer, lymph nodes metastasis of breast cancer, and bladder cancer.

Deep Bio has participated in research collaborations with multiple reputable universities and published clinical validation studies in prominent peer-reviewed journals including Cancers, a respected oncology journal.

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 approval of an AI-based cancer pathology 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 www.deepbio.co.kr.

2021.07.16
DeepBio

Spokane, WA, and Seoul, Korea (July 14, 2021) – Gestalt Diagnostics and Deep Bio today announced their strategic relationship on the development of an integrated workflow for pathologists to use Artificial Intelligence algorithms directly within Gestalt’s PathFlow® platform. Deep Bio’s algorithm analyzes whole slide images (WSIs) of H&E-stained prostate core needle biopsy tissue specimens to detect and classify prostate cancer. Using the PathFlow® platform, pathologists now have a superior support tool in diagnosing prostate cancer.

“Optimizing the pathology workflow with an interoperable solution that combines the value of Gestalt’s full digital pathology platform and Deep Bio’s DeepDx® AI algorithms enables a high throughput diagnostic process,” says Gestalt COO & Chief Strategy Officer, Lisa-Jean Clifford. “Providing pathologists with instant access to AI algorithms directly within their workflow presents them with key data in real-time, shortening the time to diagnosis for cancer patients. We are excited to be collaborating with Deep Bio to provide pathology labs, and pathologists, with this superior solution.”

“Deep Bio’s relationship with Gestalt Diagnostics brings us one step closer to our vision of supporting pathologists and oncologists with timely and accurate diagnosis and prognosis, for better treatment decision-making. We believe our AI-powered DeepDx® is a powerful addition to the seamless and integrated clinical workflow afforded by PathFlow®”, said Deep Bio’s founder and CEO Sun Woo Kim

Visit Gestalt at www.gestaltdiagnostics.com and Deep Bio at www.deepbio.co.kr to learn more.

About Gestalt Diagnostics

Gestalt Diagnostics is a private, profit-driven software company who provides technology solutions, technical and integration services and support to pathology laboratories. Gestalt has developed PathFlow, an enterprise software platform specifically designed to bring the benefits of digital workflow to pathologists and pathology laboratories. This product was originally developed, by what is now Gestalt’s team, to support a fully digital reading platform for radiology. The radiology platform is used in leading hospitals across the United States and supports more than 15 million studies annually. Gestalt has expanded and redesigned this proven, robust solution to work in the laboratory space – engineered for the unique needs and workflow of pathologists. To learn more, visit www.gestaltdiagnostics.com.

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 KFDA approval of an AI-based cancer pathology solution, Deep Bio envisions a suite of AI-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device) for diagnosis and prognosis prediction of multiple cancers. Deep Bio is actively engaged in the research space and participating in ongoing collaborations with top US medical centers.

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 group. Extensively tested at a US CLIA lab (>240k cores in 2020), 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.

Gestalt Diagnostics Contact

Lisa-Jean Clifford, ljclifford@gestaltdiagnostics.com

Deep Bio Contact

YoonMin Lee, ymlee@deepbio.co.kr

2021.07.14
DeepBio

Deep Bio developed a novel deep learning-based prostate cancer detection model that demonstrates superb performance trained by a weakly supervised learning method 

Seoul, South Korea, July 1, 2021 – Deep Bio today announced that it published research results on a study, ‘Yet Another Automated Gleason Grading System (YAAGGS),’ in npj Digital Medicine which is a part of the prestigious international science and technology journals series, Nature Partner Journals. YAAGGS is Deep Bio’s original deep learning-based Gleason grading system that detects prostate cancer and classifies cancer severity.

The study presents a new weakly-supervised deep learning-based prostate cancer detection model. The study outlines training and validation of the model using whole slide images (WSIs) and their corresponding hospital diagnoses. To demonstrate the performance of YAAGS, a total of 7,600 H&E (Hematoxylin and Eosin)-stained prostate core needle biopsy samples images were used. The specimens were provided by Hanyang University Medical Center and Korea University Guro Hospital in South Korea.

In regard to cancer detection performance, the YAAGGS model exhibited a ROC AUC value of 0.983. Its sensitivity and specificity were 93.6%, and 96.0%, respectively. For the grade group prediction, analysis showed a Cohen’s kappa score of 0.650 and a quadratic-weighted kappa score of 0.897. The study demonstrated that the model can detect and grade the severity of prostate cancer just as well as a board-certified pathologist.

Detailed annotations on regions of interest specifying the severity of cancer are known to be essential for the development of deep learning-based cancer diagnostic algorithms. However, the manual annotation process is highly inefficient in terms of development time and cost. The novel approach to deep learning showcased in this paper can be used to expedite the development of additional diagnostic models.

Sun Woo Kim, the CEO of Deep Bio, said, “The YAAGGS study suggests a new method of deep learning that can significantly reduce the time and cost required to develop a cancer diagnostic solution. At the same time, YAAGGS also demonstrated superb performance, solidifying Deep Bio’s position as a leader in AI cancer diagnostics.” He also added, “Deep Bio will continue to innovate and work to optimize the digital pathology workflow to improve patient care.”

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 KFDA approval of an AI-based cancer pathology solution, Deep Bio envisions a suite of AI-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device) for diagnosis and prognosis prediction of multiple cancers. Deep Bio is actively engaged in the research space and participating in ongoing collaborations with top US medical centers.

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 group. Extensively tested at a US CLIA lab (>240k cores in 2020), 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.

2021.07.01
DeepBio

Deep Bio stands at the front and center of digital transformation with DeepDx® Prostate

Digital pathology is on the rise – and, with it, artificial intelligence’s role in the pathology workflow.

Many pathologists are embracing the change – often young pathologists who understand that progress is inevitable.

Dedication to the cause

Deep Bio is among the companies leading the charge by developing deep learning algorithms tailored for pathologists. A biotechnology startup based in South Korea, Deep Bio was established in 2015 with the vision of integrating artificial intelligence (AI) into cancer diagnostics. Now with 34 employees, Deep Bio boasts a multidisciplinary team of medical experts, machine learning engineers, data scientists, and entrepreneurs – all working to harness the AI-driven transformation in pathology.

Deep Bio first made waves in the medical AI-space by taking first place in CAMELYON17, a global competition to assess the performance of algorithms in localizing breast cancer metastasis in the sentinel lymph node. Since then, it has continued to build on its deep learning technology to engineer algorithms for various cancer types – producing 13 registered patents and 14 pending. Through its diverse software offering, Deep Bio empowers pathologists and supports real-time clinical decisions.

Its flagship product, DeepDx ® Prostate, is an AI-powered software that automatically detects prostate cancer. Once the pathologist uploads digitized whole-slide images of H&E-stained prostate biopsy specimens, the tool generates automatic cancer detection, colored overlays of Gleason scoring, and tumor quantification within seconds. Notably, DeepDx® Prostate made headlines when it became the first AI-based cancer diagnostic support software to receive MFDS (Korean FDA) approval. “The Korean pathology community has been at the forefront of adopting AI to improve the quality of patient care,” says Sunwoo Kim, CEO and founder of Deep Bio.

What were the drivers behind this medical AI adoption? Kim explains that a clinical validation study of the algorithm, published in Cancers, played an instrumental role. “Our clinical validation study showed high diagnostic concordance between DeepDx® Prostate and the reference standard of three pathologists (0.907 quadratic-weighted Cohen’s kappa coefficient).” He continues, “This shows that our model can provide pathologist-level diagnostic support or second opinions.”

But it is not just the performance of Deep Bio’s technology that sets it apart; it goes above and beyond for its customers, too. “When we first implemented DeepDx® Prostate, Sunwoo took the initiative to bring his team with him to the US to meet our lab. When someone makes that kind of effort, it makes it much easier to work together,” says Matthew Leavitt, CEO of PathNet, a network of independent pathology practices.

Moving forward
Deep Bio shows no signs of slowing down. “There has been a high demand in the US for our software. We have already processed more than 244,000 cores from CLIA labs for testing purposes,” says Kim. “We have more AI models in the pipeline for the diagnosis of breast cancer, bladder cancer, and lymph node metastasis of breast cancer. More excitingly, our technology can quantify clinically meaningful data, such as the proportion of Gleason pattern 4, which has prognostic significance.”

Tried and tested
With Deep Bio’s years of experience behind it, DeepDx® Prostate offers a seamless process for the pathologist, bringing value to its users. “We have been using DeepDx® Prostate for a couple of years now,” says Leavitt. “Deep Bio’s initial willingness to integrate into our workflow and laboratory information system means that, after I have analyzed tissue, I can instantly check the results from DeepDx® Prostate with a simple click of a button – sometimes revealing small areas of concern that I would have missed had I not had the tool running in the background.”

DeepDx® Prostate’s speed and analytic features enable pathologists to confidently make diagnostic decisions in real time, but Leavitt understands that the company behind the algorithm is an integral part of the partnership. “DeepDx® Prostate is truly revolutionary, but it takes a lot of trust, experience, and feedback between the user and the AI developers. That’s why we have formed such a nice relationship with Deep Bio – because it handles that interaction between the user and AI developer so well.”

Min-Sun Jin – a pathologist at South Korea’s Bucheon St. Mary’s Hospital with experience using DeepDx® Prostate – eagerly agrees. She says, “DeepDx® Prostate helps pathologists diagnose cancer with increased accuracy and speed. In particular, it reduces interand intra-observer variability. In hospitals without pathology residents, using DeepDx® Prostate for screening will allow pathologists to spend more time and energy on their research.”

Sunwoo Kim is CEO and Founder of Deep Bio, Inc., Seoul, Korea.

Matthew Leavitt is CEO of PathNet, Little Rock, Arkansas, USA.

Min-Sun Jin is a pathologist at Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon, Korea.

Original Article: https://thepathologist.com/inside-the-lab/embracing-pathologys-digital-revolution-with-deep-bio

Seoul, South Korea- Deep Bio announced today that it had officially commenced clinical trial on ‘DeepDx-Prostate,’ a prostate biopsy AI-based diagnostic software. Deep Bio has recently received clinical trial plan approval from the Ministry of Food and Drug Safety for ‘DeepDx-Prostate’ and its clinical validation plan on AI-based diagnosis using prostate biopsy based H&E stained digital images.

Deep Bio will go through a verification and validation of the AI-based diagnostic software on patients who have undergone prostate biopsy using H&E stained digital images. The clinical trial will be conducted at two academic hospitals (Seoul National University Hospital, Korea University Guro Hospital) and will compare the diagnostic results between clinicians and the DeepDx-Prostate. In addition, the trial will evaluate the effectiveness of the diagnostics using AI-based software.

Pathologists confirm the diagnosis of prostate cancer through examining the prostate tissue H&E slides under a microscope. While the current examination process is pathologists visually interpreting & measuring the slides, on DeepDx-Prostate, it can analyze and calculate the percentage of cancer in the entire tissue based on pixel level. These analysis results automatically generate in the form of a pathology report. The report includes the patient’s cancer staging based on the Gleason grading system. “DeepDx-Prostate is an AI-software that assists pathologists in making decisions on cancer diagnosis, and it can further help them with selective precision readings,” Deep Bio officials said. Deep Bio is expecting approval as early as this year.

Deep Bio is pursuing to expand in the global market. In 2018, they had granted compliance on ISO13485:2016, and will soon commence on receiving European CE certification and FDA approval. The founder and CEO of Deep Bio, Kim Sun Woo said, “we are continuously expanding our global network by participating in international conferences such as USCAP, AACR and introducing our products. We plan to speed up the development process in other cancer types, such as breast cancer diagnosis.”
2019.04.11
DeepBio

The Deep Bio research team set the record in the Camelyon Challenge 17’ currently positioning them in first place. The Camelyon17 Grand Challenge is a global competition organized by the Diagnostic Image Analysis Group (DIAG) and the Radboud University Medical Center to evaluate algorithms that perform automated detection of breast cancer metastases in whole-slide images of lymph node sections.

The Deep Bio research team used their own unique artificial intelligence training method to detect metastasis and predict pN-stage from lymph node histological slides. Their proposed method achieved a kappa score of 0.9570, setting them in first place of the challenge.

2019.02.12
DeepBio

Deep Bio announced today that it had released its artificial intelligence (AI) diagnostic products for the first time in the domestic press. The company’s first AI software product ‘Deep Dx’ detects prostate cancer using H&E stained prostate biopsy WSI images.

The founder & CEO of Deep Bio, Sun Woo Kim proposed that the company has completed the preparations to enter the domestic approval process by granting ISO13485:2016 (Quality Management System on Medical Device) and KGMP (Korean medical device manufacturing and quality control standard). He additionally commented that the company is officially ready to step into the overseas market.

◇ DeepDx “ Cancer detection with 10-seconds..includes an automatic pathology report.”

Deep Bio ‘DeepDx’ AI-diagnostic software uses digitally scanned prostate biopsy image to diagnose prostate cancer. Despite the size of the high-resolution image, DeepDx can detect cancer on a WSI image and generate an automatic pathology-like report within 10 seconds.

Kim mentioned, “The pathology reporting guidelines have recommended to particularly include the percentage of Gleason pattern four as it provides clinically significant information on predicting patients prognosis.” The company’s product ‘DeepDx’ can automatically calculate the proportions of each Gleason pattern and further captures the main cancerous areas on images which are included in the report. Deep Bio’s first products were launched at the DPA (Digital Pathology Association) 2018 held in San Diego, USA and will further launch at USCAP & AACR Annual Meeting 2019.

Deep Bio CEO, Kim said, “Many pathologists are surprised at the accuracy of our products performances, and have shown significant interest.” 2019 is expected to become an important year for Deep Bio and its commercialization to expand globally. Kim added, “We are also considering attracting investment from global venture capital companies, and we will extend our service offerings to multinational pharmaceutical companies.

For more information:

http://www.biospectator.com/view/news_view.php?varAtcId=6777

2018.12.13
Biospectator

Deep Bio, an AI-powered medical service startup company, today announced that it had granted ISO 13485:2016 certification for its Quality Management System (QMS).

ISO 13485 is an internationally recognized standard for companies involved in the medical industry to obtain compliance with the quality management system.

Deep Bio emphasized achieving compliances like ISO 13485 is crucial for them to ensure the products are designed and manufactured with quality and safety for patients. The medical startup company will continue to move forward to maintain its compliance under applicable standards and receive regulatory approvals including the Food and Drug Administration (FDA) to bring their AI-medical device tools closer to the market worldwide.

2018.09.17