Deepbio – Page 5

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.

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

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.

Five abstracts in prostate and breast cancers, Deep Bio’s main research areas, are presented during the online sessions.

SEOUL, SOUTH KOREA (PRWEB) APRIL 11, 2022 – Deep Bio, a pioneer in medical AI for pathologic cancer diagnostics, presented five abstracts in regards to cancer diagnosis and prognosis of multiple cancer types using deep learning-based algorithms at the American Association for Cancer Research (AACR) 2022 which took place both in-person and virtually in New Orleans.

These studies showed notable findings when the algorithms were used for prognosis, including recurrence risk prediction and survival analysis. Particularly, a study that aimed to find out the relationship between histomorphological features of adenocarcinoma lesions and patients’ survival using a deep learning model was highlighted, drawing attendees’ attention. In the study, the deep learning-based pancreatic adenocarcinoma survival model discovered that histomorphological features show correlations with patient survival. Also, the study brought into light the possibility of applying the survival analysis to other diseases such as rectum adenocarcinoma and breast adenocarcinoma. In another study, Deep Bio’s breast cancer survival analysis model was able to distinguish between the low-risk group and the high-risk group to some extent, suggesting it can be used as a screening tool prior to the 21-gene test which classifies patients in early-stage breast cancer for whom chemotherapy can be effective.

Deep Bio also shared meaningful study results in prostate cancer, its core research area. In the study, researchers sought to detect cancerous regions and grade their severity on a whole slide image (WSI) of prostate frozen sections with deep learning-based cancer diagnosis support software. The model demonstrated high performance, achieving 98%in sensitivity for detecting malignant cases and 99% sensitivity for detecting clinically significant risk cases*.

Tae-Yeong Kwak, the CTO of Deep Bio, said, “Prognosis analysis of cancer is crucial in that it directly affects patients’ treatment and care plans. The studies presented imply that deep learning algorithms can be a great help to predict the prognosis of cancer more precisely. Deep bio will continue its efforts to make these technologies for real clinical settings.”

“By presenting significant research results at this year’s AACR, Deep Bio not only showcased its commitment to AI-based cancer diagnosis and digital pathology but also expanded its presence globally. With the proven and tested technologies, we will lead digital pathology and AI through close partnerships with clinics, research institutes, and digital pathology platform providers,” said Sun Woo Kim, the CEO of Deep Bio.

Deep Bio continues to focus on not only AI diagnostics but also R&D and presenting the results at 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.
Abstracts Presented Included (E-Posters):

Breast cancer survival analysis with the size of the infiltrative cancer area
Automated Gleason grading of digitized frozen section prostate tissue slide images
Recurrence risk prediction based on automatic histopathologic analysis of breast cancer using whole slide images
A deep learning based pancreatic adenocarcinoma survival prediction model applicable to adenocarcinoma of other organs
Molecular mapping of prostate cancer on whole mount prostatectomy specimens using deep neural networks to quantify genotypic heterogeneity

(* clinically significant risk cases: Grade group 2 or over)
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.

Join Deep Bio at AACR 2022! At this year’s AACR, Deep Bio will present both on-site and virtually!

Visit us at booth #1461 to share your thoughts on the role of digital pathology and AI in cancer research. Also, don’t forget to see the latest version of DeepDx® Prostate, our innovation in cancer diagnostics.

For a meeting and a live demo, please send an email to sales@deepbio.co.kr or visit www.deepbio.co.kr.

While we have a booth exhibition in person, there will be 5 abstracts from our latest research, which will be presented during the online sessions.

▶ E-Poster Presentation schedule: Apr 8 2022 12:00PM – 1:00 PM

#5054 Breast cancer survival analysis with the size of the infiltrative cancer area / Presenter: JunYoung Choi

#5056 Automated Gleason grading of digitized frozen section prostate tissue slide images / Presenter: Joonyoung Cho

#5058 Recurrence risk prediction based on automatic histopathologic analysis of breast cancer using whole slide images / Presenter: Geongyu Lee

#5060 A deep learning based pancreatic adenocarcinoma survival prediction model applicable to adenocarcinoma of other organs / Presenter: Joonho Lee

#5061 Molecular mapping of prostate cancer on whole mount prostatectomy specimens using deep neural networks to quantify genotypic heterogeneity / Presenter: Joonyoung Cho

Author: Deepbio

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

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

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

[Posters] AACR 2022 – Breast Cancer Survival Analysis with the Size of the Infiltrative Cancer Area

[Posters] AACR 2022 – Automated Gleason Grading of Digitized Frozen Section Prostate Tissue Slide Images

[Posters] AACR 2022 – A Deep Learning based Pancreatic Adenocarcinoma Survival Prediction Model Applicable to Adenocarcinoma of Other Organs

[Posters] AACR 2022 – Recurrence Risk Prediction Based on Automatic Histologic Analysis of Breast Cancer Using Whole Slide Images

[Posters] AACR 2022 – Molecular Mapping of Prostate Cancer on Whole Mount Prostatectomy Specimens Using Deep Neural Networks to Quantify Genotypic Heterogeneity

Deep Bio Presents Research Results of AI-based Cancer Diagnosis and Prognosis at the AACR Annual Meeting 2022

Join Deep Bio at AACR 2022!

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