Medical Device Daily

If “automation” is the key word in the modern testing laboratory, then Ikonisys (New Haven, Connecticut) is spelling it out in terms of bladder cancer.

Earlier this week the company reported FDA clearance for the first test in its bladder cancer pipeline, the second of its two product lines, and will now promote its automated features as offering a high level of automation to improve speed and accuracy.

Called the oncoFISH bladder test, this assay was given the go-ahead for both screening and monitoring in bladder cancer, the fifth most common cancer in the U.S. In conjunction with the company’s Ikoniscope robotic digital microscopy platform, oncoFISH bladder is designed to enable automated testing of cells found in urine specimens to aid in the detection of bladder cancer.

Paul White, CFO and VP of business development, told Medical Device Daily:

“We’re excited about it, because it secures us with one in each of our product lines” — the other line being the Fast FISH auto-amniocyte application — “and we believe this nicely will position us for more adoption of the platform.

“And when [technicians] become more comfortable with the platform, they’re also likely to put more applications on it, which we have in development.” In a statement, the company said that oncoFish bladder is expected to “significantly reduce the time required to process test results.”

The product is available now, White said.

The software and Ikoniscope together provide a product suite designed to automate a standard but time-consuming, laboratory technique, fluorescence in situ hybridization (FISH), which identifies chromosome aberrations associated with various diseases, the company said. oncoFISH bladder detects aberrations for chromosomes 3, 7, 9 and 17 in cells found in urine sediment to aid in the initial diagnosis of bladder cancer in patients who have hematuria, that is, blood in the urine.

It will also be used for subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

White, citing information from the American Cancer Society (Atlanta) and the National Cancer Institute, said that currently there are about 600,000 people with bladder cancer. The recurrence rate is about 70%.

The oncoFISH bladder is designed to work in concert with UroVysion, a test distributed by Abbott Molecular Diagnostics (Des Plaines, Illinois), which provides the reagents for the test.

To do this, a lab technician views slides under a manual microscope and then loads the slides into the Ikonisys instrument, which then performs digitalization of the images and analysis on the images “to reach an initial conclusion,” White said.

Ikonisys received its first test application clearance in September, when the FDA cleared the fastFISH auto-amniocyte application, providing automated identification and enumeration of chromosomes 13, 18, 21 X and Y in amniotic fluid in pregnant women, to detect any aberrations associated with common birth defects, such as Down syndrome (MDD, Sept. 29, 2006).

The company said at that time that it had several tests in the development pipeline, including a fetal cell assay, a rare cell detection test that allows for studying fetal cells through maternal blood, making it noninvasive.

White told MDD that the company expects to have more FDA submissions for additional test applications by the end of this year.

He said the company is looking to expand its product lines and is “looking at other tests around cancer.”

“Most of them are tests that exist today, and we would look to automate them,” he said. “Most of them are tests that we would sell both components — the reagent part, as well as the application part on our instrument.”

The company has said that systems like the Ikonisys Ikoniscope are necessary as consumers increasingly want genetic tests.

And the robotic/automation component is important to labs as they increasingly face labor shortages, a major issue of concern in the field.

Ikonisys was founded in 1999, and it has grown from about 35 employees in September to 43 employees currently, White said.