Applied Imaging (San Jose, California) showed off its new multistain analysis assay to operate on the company’s flagship Ariol imaging analysis platform during last week’s annual meeting of the American Society for Cell Biology (Bethesda, Maryland) in San Francisco.

Multistain analysis is based on the company’s core expertise in research, and the assay allows clinicians to “stain a slide with more than one marker,” according to Brandon Steele, Applied Imaging’s director of commercial operations for the Americas.

Speaking by telephone from the conference, Steele told Diagnostics & Imaging Week: “We have a lot of core expertise in using tissue microarrays for research that we think we can extend on in the clinical environment.”’

The Multistain assay is designed to allow pathologists to evaluate all of the markers simultaneously. “That speeds the throughput on the system because you can look at multiple markers at the same time,” he said. “It also allows you to pull more data out of one tissue sample.”

Applied Imaging’s technical product manager for pathology, Iqbal Habib, said that while “the technology is there” for technicians individually to prepare two stains, or three stains in a traditional laboratory setting, there is also “a lot of hesitation from the practical level, because it’s hard to sort of evaluate all these markers at the same time with the human eye.”

Habib added: “With this particular [multistain anaylysis] algorithm ... [it’s easier] because it allows you to colorize” the results and “visualize it a lot easier and keep track of that information.”

The Ariol system is approved for the clinical lab for a breast cancer panel that includes Ariol Her-2/neu FISH (fluorescence in situ hybridization) assays which is designed to detect Her-2/neu gene amplification in breast cancer biopsy with that method of analysis.

That approval, which came in May, “complements and completes the breast cancer panel” on the Ariol system, which also includes 510(k)-cleared assays for Her-2/neu immunohistochemistry, estrogen receptor and progesterone receptor, the latter two approvals having being granted by the FDA in March 2004.

The system involves in the front an interface for data entry, and every slide is given a unique bar code, Habib said, noting that the bar code contains information such as patient demographics, tissue type and the particular assay of interest. The system then reads the barcode and “pulls that information from the database, and therefore the system understands how best to handle that slide, [i.e.], the analysis data, the images.”

Initially, the system scans the slide at a lower magnification to offer what Habib termed a “bird’s-eye view of where the tissue resides on the slide.” The assay also has algorithms that “detect the perimeter of the tissue.”

Once the Ariol system identifies these aspects of the slide, it transitions to a higher magnification, which, depending on the type of assay being used, could go to 20x or 200x magnification. At this point, the technician either automatically applies an analysis algorithm to identify staining, such as what concentration, percentage or intensity, or uses “drawing tools” on the monitor to select a “sub-area, or a specific area of the tumor that they really want to hone in on and identify.”

Because cancers vary from ductal or infiltrating or some other type, “Sometimes the user wants to specify a specific area of invasive cancer,” Habib said. “The system doesn’t automatically say this is invasive [and] that’s where the user sort of drives a direction to the system.”

According to Steele, “Part of the FDA clearance we have for these products is that we’re not allowed to substitute for the opinion of the pathologist, but the Ariol is an aid to the pathologist in the sense that it provides quantitative analysis of the amount of staining in the results.“

Ultimately, Ariol is designed to enable pathologists to have a greater intensity image, Habib said, taking it to the “granular” level.