Regulatory barriers surrounding the use of whole slide imaging in the United States of America

Parwani, Anil V.; Hassell, Lewis; Glassy, Eric F.; Pantanowitz, Liron

doi:10.4103/2153-3539.143325

Cited by 43 publications

(33 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Going forward, proposed technical performance parameters and regulation of digital imaging have been outlined by the FDA and discussed by others. [113637] One potential limitation to this study is that each pathologist completed the histology evaluation remotely using their own microscope and computer, with no standardization. We do not have information on their workstation and monitor specifications or internet and bandwidth capabilities.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Elmore

Longton

Pepe

et al. 2017

Journal of Pathology Informatics

View full text Add to dashboard Cite

Background:Digital whole slide imaging may be useful for obtaining second opinions and is used in many countries. However, the U.S. Food and Drug Administration requires verification studies.Methods:Pathologists were randomized to interpret one of four sets of breast biopsy cases during two phases, separated by ≥9 months, using glass slides or digital format (sixty cases per set, one slide per case, n = 240 cases). Accuracy was assessed by comparing interpretations to a consensus reference standard. Intraobserver reproducibility was assessed by comparing the agreement of interpretations on the same cases between two phases. Estimated probabilities of confirmation by a reference panel (i.e., predictive values) were obtained by incorporating data on the population prevalence of diagnoses.Results:Sixty-five percent of responding pathologists were eligible, and 252 consented to randomization; 208 completed Phase I (115 glass, 93 digital); and 172 completed Phase II (86 glass, 86 digital). Accuracy was slightly higher using glass compared to digital format and varied by category: invasive carcinoma, 96% versus 93% (P = 0.04); ductal carcinoma in situ (DCIS), 84% versus 79% (P < 0.01); atypia, 48% versus 43% (P = 0.08); and benign without atypia, 87% versus 82% (P < 0.01). There was a small decrease in intraobserver agreement when the format changed compared to when glass slides were used in both phases (P = 0.08). Predictive values for confirmation by a reference panel using glass versus digital were: invasive carcinoma, 98% and 97% (not significant [NS]); DCIS, 70% and 57% (P = 0.007); atypia, 38% and 28% (P = 0.002); and benign without atypia, 97% and 96% (NS).Conclusions:In this large randomized study, digital format interpretations were similar to glass slide interpretations of benign and invasive cancer cases. However, cases in the middle of the spectrum, where more inherent variability exists, may be more problematic in digital format. Future studies evaluating the effect these findings exert on clinical practice and patient outcomes are required.

show abstract

Section: Discussionmentioning

confidence: 99%

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Elmore

Longton

Pepe

et al. 2017

Journal of Pathology Informatics

View full text Add to dashboard Cite

show abstract

“…The US FDA, arguably the most influential regulator in the world, has previously considered digital slide scanners a class III medical device. These are considered to be a new technology, meaning that a rigorous clinical trial of validity must be submitted to obtain approval [so‐called ‘pre‐market approval’ (PMA)], implying that full‐scale clinical trials are required to prove their safety . The FDA has proposed requirements for any trial of a whole slide imaging device .…”

Section: The Regulatory Environmentmentioning

confidence: 99%

Digital pathology in clinical use: where are we now and what is holding us back?

2016

View full text Add to dashboard Cite

Whole slide imaging is being used increasingly in research applications and in frozen section, consultation and external quality assurance practice. Digital pathology, when integrated with other digital tools such as barcoding, specimen tracking and digital dictation, can be integrated into the histopathology workflow, from specimen accession to report sign-out. These elements can bring about improvements in the safety, quality and efficiency of a histopathology department. The present paper reviews the evidence for these benefits. We then discuss the challenges of implementing a fully digital pathology workflow, including the regulatory environment, validation of whole slide imaging and the evidence for the design of a digital pathology workstation.

show abstract

“…Only our approach does not change the pathologist’s medical practice from the microscope. The microscope is a class I device appropriate for primary diagnosis according to the United States Food and Drug Administration, while whole slide imaging devices are class III [20]. …”

Section: Scientific Backgroundmentioning

confidence: 99%

DeepScope: Nonintrusive Whole Slide Saliency Annotation and Prediction from Pathologists at the Microscope

Schaumberg

Sirintrapun

Al‐Ahmadie

et al. 2017

Computational Intelligence Methods for Bioinformatics and Biostatistics

View full text Add to dashboard Cite

Modern digital pathology departments have grown to produce whole-slide image data at petabyte scale, an unprecedented treasure chest for medical machine learning tasks. Unfortunately, most digital slides are not annotated at the image level, hindering large-scale application of supervised learning. Manual labeling is prohibitive, requiring pathologists with decades of training and outstanding clinical service responsibilities. This problem is further aggravated by the United States Food and Drug Administration’s ruling that primary diagnosis must come from a glass slide rather than a digital image. We present the first end-to-end framework to overcome this problem, gathering annotations in a nonintrusive manner during a pathologist’s routine clinical work: (i) microscope-specific 3D-printed commodity camera mounts are used to video record the glass-slide-based clinical diagnosis process; (ii) after routine scanning of the whole slide, the video frames are registered to the digital slide; (iii) motion and observation time are estimated to generate a spatial and temporal saliency map of the whole slide. Demonstrating the utility of these annotations, we train a convolutional neural network that detects diagnosis-relevant salient regions, then report accuracy of 85.15% in bladder and 91.40% in prostate, with 75.00% accuracy when training on prostate but predicting in bladder, despite different pathologists examining the different tissues. When training on one patient but testing on another, AUROC in bladder is 0.79±0.11 and in prostate is 0.96±0.04. Our tool is available at https://bitbucket.org/aschaumberg/deepscope

show abstract

Regulatory barriers surrounding the use of whole slide imaging in the United States of America

Cited by 43 publications

References 11 publications

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Digital pathology in clinical use: where are we now and what is holding us back?

DeepScope: Nonintrusive Whole Slide Saliency Annotation and Prediction from Pathologists at the Microscope

Contact Info

Product

Resources

About