Modern technology could change how pathologists examine tissue samples

The days of pathologists viewing tissue samples on glass slides under a microscope might be drawing to an end. New technology granted marketing rights on the day of April 12 by the Food and Drug Administration enables the review and interpretation of digital surgical pathology slides prepared from biopsied tissue.

Philips Medical Systems got the FDA approval for its Philips IntelliSite Pathology Solution, or PIPS.

“The system enables pathologists to view and read tissue samples digitally in case to make diagnoses, instead of looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” Albert Gutierrez, director of FDA’s Office of In Vitro Diagnostics and Radiological Health stated.

The approach has the possibility to bring efficiencies to healthcare agencies by digitizing pathology procedures that have relied extensively on physical storage of specimens.

“Because the system digitizes slides that would otherwise be stored in physical files, it also gives a streamlined slide storage and retrieval system that may finally assist to make critical health information available to pathologists, other healthcare professionals and sufferers faster,” Gutierrez states.

Pathologists are scientists practicing the research of disease and making diagnoses by viewing tissues, organs, body fluids and autopsies. In contrast to the present practice of mounting tissue on a slide and applying stain to ease viewing and evaluation, PIPS scans and digitizes conventional slides with resolution of as much as 400 times magnification.

By utilizing PIPS, pathologists yet must put a tissue sample on a slide, but then a digital image is taken, enabling the corresponding increase in resolution.

When slides are digitized, they are available for query in a database, as opposed to current practices of slides placed in a physical filing system that the pathologist thumbs through to find the right slide.

Readings, the FDA warns, do not change because the tissue samples are on a digital platform.

In clearing PIPS to enter the market, FDA utilized a recently adopted accelerated review and decision procedure that quickens approval of new low or moderate risk innovations not substantially equivalent to already-marketed devices in an effort to speed medical innovation.

FDA approval came after the organization evaluated data from about 2,000 pathology cases using tissues from several parts of the body. Results discovered that diagnoses made using PIPS images were comparable to findings using glass slides. Risks of utilizing PIPS are similar to those of traditional microscope findings.