Diagnositcs & Imaging Week

Ikonisys (New Haven, Connecticut), a developer of cell-based technologies, reported FDA clearance of its fastFISH (Fluorescence In Situ Hybridization) auto-amniocyte application for marketing, giving the company the first cleared test application for its Ikoniscope microscopy instrument.

The fastFISH auto-amniocyte application is designed to allow for the automated identification and enumeration of chromosomes 13, 18, 21, X and Y in amniotic fluid in pregnant women. Ikonisys said that "numerical aberrations" of those chromosomes are associated with common birth defects, including Down syndrome.

Paul White, vice president and CFO for Ikonisys, told Diagnostics & Imaging Week that the FDA clearance of its first test is "absolutely" a milestone for the company.

"Our goal is to become a standard in digital robotic microscopy, and so we've got an instrument platform that is a standalone, walkaway-type microscopy platform that's high-throughput," White said. "And we believe it will enable labs to do a lot more of the types of tests that consumers are looking for."

The demand for, in particular, genetic testing is only going to increase, he said, and this first FDA-cleared product from the company indicates that its technology is "not only viable, but helpful in expanding these lab markets."

Ikonisys has two product lines: fastFISH, geared toward prenatal and postnatal testing, and oncoFISH, directed toward cancer diagnostics and monitoring.

The company has several tests in the development pipeline, including a fetal cell assay that is a rare cell detection test that allows for studying fetal cells through maternal blood, making it non-invasive.

"It will yield the same results as the [auto-amniocyte test] that was just cleared, but it will do it in a non-invasive way," White said.

The high-throughput Ikoniscope begins operation with a lab tech preparing slides "in the way that they do today," White said. But instead of viewing the slides using an optical microscope, the lab tech can load the slides onto the instrument, which White said will take up to 175 slides per run.

The machine loads the slides, scanning them in low magnification to "target cells that read scientific protocols of the artificial intelligence application" that is contained in the device.

The instrument then scans slides in high magnification to "capture cell images" so that a diagnosis can be made regarding whether or not there is an abnormality and "generate a preliminary diagnostic result." The pathologist still has to read the result.

"Essentially, we've taken out all the grunt work, if you will, finding the cells that are of interest that are used to make a diagnosis," White said.

White said that Ikonisys has had "a lot of interest" from labs which are facing a "central challenge."

"The consumer base wants to do more and more sophisticated testing, specifically at the genetic level," he said. Futhermore, "the people who are doing the tests [apparently] like the fact that you can see the structure results in a cell, as opposed to a molecular quantified type of result," which would be found in a microarray.

Lab personnel and technicians are "being stressed," he said, because more tests require more people who can perform such tests and there are "scarce resources to go around."

"Our focus is on leveraging the resource so that they can in fact do more tests," he said.

Another test in its fastFISH development pipeline is one to be conducted prior to implantation of an embryo following in vitro fertilization in a woman for "pre-implantation genetic diagnosis," or fastFISH PGD.

According to Ikonisys, "recent studies have shown that selection of chromosomally normal embryos, through chromosome FISH analysis, almost doubles the term birth rate, from 10% to [about] 20%."

In its cancer diagnostic product line, for example one test is oncoFISH bladder for bladder cancer detection "to be used as an initial diagnosis of bladder carcinoma and subsequent monitoring for tumor recurrence." That test is currently used in the U.S. for research use only.

Another test in its oncoFISH product pipeline is for quantification of the Her 2/Neu gene, which is a prognostic indicator in breast cancer.

In March, the company raised $10 million in a Series D private equity financing. That round was led by Trevi Health Ventures, with a syndicate of existing and other new investors, including St. Simeon LDA, New Science Ventures, WHI Group and Lakeview Capital Management.

At the time, the company said it expected to "rapidly advance" its prenatal diagnostics program to FDA submission and further develop its oncology program.

"This financing will facilitate the completion of the clinical development of the fetal cell detection test, a test that could significantly impact the healthcare of its intended users and help position Ikonisys in the center of an exciting segment of the diagnostic market," said Petros Tsipouras, MD, CEO and chairman.

The company was founded in 1999 by three individuals: CEO Tsipouras; Triantafyllos Tafas, PhD who is the company's current chief technology officer; and Michael Kilpatrick, who is the vice president of biology.

Ikonisys has "about 35" employees, White said, noting that it is looking to grow that number.