FDA Guidance for Pathology Peer Review
The FDA guidance for pathology peer review has recently been released (July 2019) as a draft version for industry feedback. The guidance for industry, when finalized, will represent the current thinking of the Food and Drug Administration (FDA), but is not binding. While alternative approaches are allowed if they satisfy the requirements of the applicable statutes and regulations, the majority of instances will seek to follow the FDA draft guidance.
Background to Peer Review
The histopathological assessment of tissue samples is a key component of GLP-compliant toxicology studies, and includes an initial read of tissue slides by the study pathologist and may include a subsequent review (referred to as pathology peer review) by a second, or peer-review pathologist. Pathology peer review can be particularly useful in situations where unique or unexpected findings are noted or when the peer-review pathologist has a particular expertise with a class of compounds.
While pathology peer review can be valuable when performed during the conduct of a GLP study, pathology peer review is not specifically addressed in the GLP regulations. This FDA guidance is intended to provide information to sponsors and nonclinical laboratory staff who choose to undertake pathology peer review during the conduct of a GLP study.
Where Does Telepathology Fit in GLP Pathology Peer Review
“Yes, it is possible to conduct a pathology peer review outside of a GLP-compliant site for a GLP-compliant study provided certain safeguards are in place to protect the integrity of study data. It is preferable that the peer-review pathologist perform the review at the GLP-compliant testing facility after receiving the appropriate training on GLP principles and relevant internal standard operating procedures (SOPs); however, if the peer review is conducted at a non-GLP compliant site, that fact should be recorded and justified within the study protocol and final study report.
Regardless of where the peer review is conducted, the name, affiliation, and location (i.e., address) of the peer-review pathologist should be clearly stated in the final study report. Also, the name, qualifications (including GLP training), affiliations, and address of the peer-review pathologist should be documented in the study file. The portions of the study that were not conducted under GLP compliance should be explicitly stated in a study director-signed GLP compliance statement and included in the final study report.”
Augmentiqs Real-Time Telepathology
Providing the technological platform for conducting GLP pathology peer review in nonclinical studies
Utilizing telepathology for peer review in glp nonclinical studies
The following statement has been prepared with the assistance of a Contract Research Organization currently utilizing Augmentiqs telepathology for GLP peer review in nonclinical/preclinical studies. For the full statement, download the paper from the link on this page.
“The histopathology primary evaluation and peer review are evaluated using the appropriate Standard Operating Procedures (SOP), respecting the GLP regulations. The study pathologist (SP) and peer review pathologist (PRP) evaluate the glass slide specimens which provides the basis for data entry, the pathology report, and peer review statement (Morton et al, 2010).
The use of the Augmentiqs system for live histopathology sessions by the SP and PRP serves for illustrative purposes, without any QA audit or regulatory issues. Digital images may be taken for illustrative purposes (Tuomari et. al, 2007). These images are not used for data generation or interpretation, and will not be archived or included in the final report.
Protocol for using Augmentiqs telepathology in GLP Peer Review
Upon completion of the slide review, the peer review pathologist may prepare a LIVE-TELEPATHOLOGY REVIEW REPORT, which documents the procedure of the review of slides, use of the live telepathology technology, and may include representative photos of microscopic fields of the slides which were shared.
This unofficial report serves as study notes, and is shared between the pathologist/s that took part in the review. This is not part of any formal study record. Eventually, the study pathologist and peer reviewer pathologist will sign a FORMAL PEER REVIEW STATEMENT, indicating that there is consensus on all study diagnoses that were peer reviewed. This document is eventually included in the formal study report.
Charles River Experience with Augmentiqs
Charles River Laboratories (CRL) performed an in-depth ROI analysis on the Augmentiqs telepathology solution and realized a complete ROI within several months of routine use.
CRL also compared Augmentiqs to WSI and 3rd ocular cameras for telepathology, and found Augmentiqs outperformed WSI and 3rd ocular cameras for quality, ease of use, innovation and speed.
CRL is now using Augmentiqs telepathology for GLP nonclinical peer review.
Advantage of Augmentiqs for GLP nonclinical pathology studies
Augmentiqs is a low-cost telepathology solution that meets the requirements of GLP compliant pathology peer review.
Easy Integration in any Microscope
Augmentiqs operates from the existing microscope.
By retrofitting the pathologist’s microscope, Augmentiqs keeps the cost of peer review low.
High-Resolution Image Quality
Augmentiqs utilizes a a high-resolution camera to capture and share a live view of the tissue.
The peer review and study pathologist may perform annotations, morphometric calculations, utilize quantitative toolsets such as nuclei or color segmentation, or compare digital images to the existing slide.
Augmentiqs ensures remote pathologists receive a full-resolution image – regardless of their Internet bandwidth.
Augmentiqs further enhances the telepathology experience by projecting an augmented overlay of digital information on top of the optical field of view within the microscope eyepiece.
Unlimited Number of Participants
Augmentiqs supports a theoretically unlimited number of remote viewers for a simultaneous connection.
Augmentiqs a combined hardware & software solution that is easily integrated in the existing microscope.
Augmentiqs includes a complete annotation and morphometric software suite that can be viewed and manipulated by all remote viewers.
Click here to learn more about annotation software.
Real-time telepathology can be used in GLP pathology peer review
Telepathology for Pathologists
When compared to other telepathology solutions, Augmentiqs enables multi-directional communication while not forfeiting image quality. It is ideal for pathology peer review, maintaining the real-time aspect of the microscope with a low-cost platform .
Click here to read a peer reviewed article on Augmentiqs telepathology.