Ikonisys’s Automated Cell Assay System Could Open the Door to New Diagnostic Tests

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could lead to a non-invasive alternative to amniocentesis or chorionic villus sampling to check fetuses for chromosomal abnormalities that could indicate Downs Syndrome or other problems. Instead of taking a sample out of the uterus, doctors merely draw a blood sample from the mother and look for the rare fetal cell than may have been shed by the placenta into the maternal bloodstream. Those usually occur at a rate of only two to five cells per milliliter of maternal blood. It’s simply not practical to do such a scan manually, but the automated system can do it, thus removing the risks, such as miscarriage, of the more invasive tests. “It’s trading a long needle that goes into a place you don’t really want to see it go for taking a tube of blood,” White says.

Another thing the system could look for would be cancer cells shed by a tumor and circulating in the bloodstream, even when the tumor’s too small to image. “It pushes the window of diagnostic detection much earlier,” Tsipouras says.

Such a test could be a useful backup to the prostate specific antigen (PSA) tests given to men to look for prostate cancer. If doctors find an elevated PSA level, they then do a prostate biopsy to see if there’s cancer. But 80 percent of the tests that first show elevated PSA turn out to be false positives, Tsipouras says. “PSA is a famously inaccurate test.”

With a test Ikonisys is developing, doctors could perform the PSA test, and in the event of a positive result they could run the Ikonisys test to cut down on the number of unnecessary biopsies.

The company began marketing the automated system last year, starting with a test for bladder cancer and another for abnormalities on amniocytes that would indicate birth defects. Both of those use chemical reagents developed by Abbott Laboratories. Later this year, it plans to introduce another test, based on a third-party reagent, to look for signs of breast cancer.

But Ikonisys is also developing its own testing reagents and plans to introduce two this year, one for the circulating fetal cells, and one to look for cervical cancer. Though the company’s major product right now is the microscope system and associated software, White says in the long run the reagents will be the main focus.

Earlier this month, Ikonisys launched a clinical laboratory for its rare-cell-based tests. Under Food and Drug Administration “home brew” rules, the company can use its tests in-house before it receives FDA approval to sell to others. That allows the firm to sell testing services, instead of testing products, while helping to validate its technology. The company doesn’t plan to become a clinical testing service, however. White says as tests receive FDA approval, they’ll be moved out into the marketplace.

Tsipouras founded Ikonisys in 1999, along with Triantafyllos Tafas, a professor of biology at the University of Athens, Greece; and Michael Kilpatrick, a biologist at the UConn Health Center. Though it’s based in Yale Science Park, Ikonisys is not a spinoff of either UConn or Yale, and the company owns all its intellectual property. Tsipouras says the firm has filed about 65 patent applications, about 15 of which have been issued.

The company has 85 employees, and closed a Series E financing round last October for $30 million, with investments from Goldman Sachs, Trevi Health Ventures, Palisade Capital, and others. “It’ll carry us for quite some time,” White says, adding that, with sales already ongoing in both the U.S. and Europe, revenues should cover more and more of the budget. Total funding, including that round, is $67.5 million.

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