The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics development.
Digital Pathology is a new technology, a new industry, where organizations like CLIA, CAP and the FDA provide limited guidance, and the manufacturers still have to learn what it means to provide instruments into a clinical laboratory.
With Digital Pathology now entering the clinical laboratories, it is crucial for physicians and laboratory professionals to understand the regulatory requirements and how to best implement Digital Pathology in their clinical laboratories.
For the past 4-5 years I have worked for a leading Digital Pathology manufacturer. I was responsible for their first product in the clinical market – a digital IHC workflow solution, and their portfolio of FDA clearances. Now I have put together a presentation that summarizes my experience in the clinical market. I hope it will help many physicians and laboratory professionals to quickly get up to speed on how to deal with the implementation of Digital Pathology in their clinical laboratories.
These are the subjects that are covered in the presentation:
Clinical Laboratory Regulations
A discussion on how the CLIA standard and the CAP checklist apply to Digital Pathology. A review of the new ASCO/CAP guidelines for HER2 and ER/PgR for the latest thoughts on standardization and validation in clinical laboratories.
Medical Device Manufacturer Regulations
An overview of the existing US Food and Drug Administration (FDA) clearances for Digital Pathology with an example of a successful study design. A discussion on the FDA advisory panel meeting on Digital Pathology Whole Slide Imaging (WSI) for the latest thoughts on what it takes to validate Digital Pathology systems for primary diagnosis.
Digital Pathology Systems
Practical tips on how to implement a digital pathology system in a clinical laboratory and how digital pathology manufacturers could make it easier. A demo of how a digital pathology system can help with the logistics of its own validation. A discussion on how going digital could be a game changer for the standardization of pathology, looking at the example of the automatic standardization of staining, using standard controls and automatic image analysis.
Go to the Flagship Biosciences product page for digital pathology regulatory products.
You get an 1½ hour video presentation on a DVD and the presentation transcript.
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