Investors Commit $30M to Rare-Cell Detection Tests

Ikonisys, a New Haven, CT, company that makes cell-based diagnostics for women’s health and oncology, has closed $30 million in Series E funding. The financing follows FDA clearance of two diagnostic applications for use in conjunction with Ikonisys’ Ikoniscope digital microscopy platform.

The Ikoniscope is a fully automated microscopy platform that provides walk-away functionality, enabling real-time scanning and preliminary analysis of slide samples. Based on Ikonisys’ CellOptics technology, which fuses cell and molecular biology, microscopy, artificial intelligence and informatics, the Ikoniscope supports the automation of existing tests and Ikonisys’ own rare-cell detection tests.

The company anticipates releasing the first two of its rare-cell detection tests — fastFISH, for the prenatal detection of chromosome abnormalities in the fetus, and oncoFISH, for cancer detection — in 2008.

In 2006, Ikonisys obtained FDA clearance for fastFISH, which enables automated identification, enumeration and analysis of chromosomes 13, 18, 21, X, and Y in amniotic cells. Numerical aberrations of these chromosomes are associated with common birth defects including Down syndrome.

FDA clearance for oncoFISH bladder came in early 2007. The test 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 with hematuria (blood in the urine) and the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

In the pipeline now is oncoFISH breast, which is being developed for the automated analysis of chromosome FISH signals associated with the amplification of the HER-2/neu gene in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.

This latest round — in which new investor Goldman Sachs joined existing investors Trevi Health Ventures, Palisade Capital, Everfin, Lakeview Capital Management, New Science Ventures, Promark Holdings SA, Saint Simeon – e Investimentos, Lda, and WHI Group — nearly doubled the amount of money Ikonisys had raised to date. Prior to completing the Series E, the company had raised $37.5 million total. Ikonisys’ Series D round was for $15.5 million and led by Trevi Health Ventures.