New immunohistochemistry image analysis application brings pathologistsa step closer in the fight against breast cancer.
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The U.S. Food and Drug Administration (FDA), Rockville, Md., has given Aperio Technologies, Inc., Vista, Calif., the green light to market the HER2 (human epidermal growth factor receptor 2) complete image analysis application—the ScanScope XT digital slide system. The FDA-cleared immunohistochemistry (IHC) image analysis application enables pathologists to detect and quantify HER2 protein expression from digital slide images created by Aperio’s slide scanning systems.
The HER2 gene is part of a family of genes that plays a part in regulating cell growth. For reasons yet unknown, some breast cancers, as part of their development, undergo a gene amplification. Instead of having two gene copies of the HER2 gene in a normal cell, there are multiple copies. As a result, there is far more expression of the HER2 protein on the cell surface, resulting in aberrant cell growth regulation.
“FDA approval for the HER2 image analysis application provides clinical customers with access to powerful quantitative image analysis algorithms for breast cancer pathology,” says Dirk Soenksen, CEO and founder of Aperio, “while allowing them to benefit from the most advanced digital pathology system available today.”
Scan, view, and collaborate
Time is of the essence when dealing with cancer, and Aperio’s ScanScope XT digital slide scanner can scan an entire glass slide in a matter of minutes. The scan time is proportional to the area of the slide that is scanned and the resolution. Generally a 15 mm x 15 mm slide will scan at 20x in under 2 min. High numerical aperture 20x or 40x objectives produce full color, high-resolution giga-pixel digital images of cells, tissues, and tissue arrays.
All aspects of slide scanning are fully automatic. Once a slide has been loaded, the ScanScope scanner automatically finds the areas of the slide containing tissue and determines the tissue contour information necessary to maintain accurate focus during scanning. The images can then be analyzed using image analysis software or stored and cataloged as a searchable image data base.
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The ScanScope XT uses a linear-array scanning technique that generates digital slide images that have no tiling artifacts and are essentially free from optical aberrations along the scanning axis. The data are immediately viewable. Pathologists can rapidly zoom in and pan the slide images to any desired magnification at any point on the slide. A reference macroscopic (thumbnail) image on the screen pinpoints the spot being looked at on the slide.
The system also enables side-by-side coordinated viewing of multiple slides, something that cannot be done with traditional glass slides. In addition, Aperio’s SmartSync feature makes it easy to compare different sections from the same tissue block, even when sections are rotated or translated with respect to one another.
Spectrum, the freely downloadable software used to run the system, includes a Web application and services which encapsulate database and digital slide image access for other computers. This allows live, interactive conferences/collaboration sessions where several parties in multiple locations can navigate a digital slide, and every party can see the same portion of the digital slide simultaneously. The graphical annotations from the session leader (which can be passed to any session attendee) are visible on all participants’ monitors, as is the leader’s mouse location—visible as a “pointer”.
Resources
• Aperio Technologies, Inc., Vista, Calif., 866-478-4111,
www.aperio.com
• FDA, Rockville, Md., 888-463-6332,
www.fda.gov
Published in R & D magazine: Vol. 50, No. 1, February, 2008, p.38.
