NEW HAVEN, Conn.--(BUSINESS WIRE)--Ikonisys, Inc. a leading provider of next-generation, cell-based diagnostic solutions, announced today that it has achieved two milestones in the commercialization of their oncoFISH cervical test: the receipt of New York State certification to offer oncoFISH cervical and the company’s first customer.
The test, which launched in September, recently received New York State certification allowing Ikonisys to offer the test to New York State customers through its CAP accredited, fully licensed clinical laboratory. In addition, Ikonisys has signed its first customer, New England Pathology Associates, P.C., which will offer the test to physicians. The test will be performed at the Ikonisys Clinical Laboratory located in New Haven, Conn.
“Until now, physicians had no tool to help assess cervical disease risk for women diagnosed with low grade squamous lesions. oncoFISH cervical is an advancement in risk stratification, which will result in improved patient management for a woman diagnosed with an abnormal Pap. We are pleased to be the first to offer oncoFISH cervical to our physicians,” said Dr. Bruce Dziura, Chief of Cytopathology of New England Pathology Associates at Mercy Medical Center, Springfield. Mass.
The oncoFISH cervical test is a fluorescence in situ hybridization (FISH) test for determining the acquisition of specific chromosomal aberrations in cytological specimens. oncoFISH cervical provides physicians with additional information that can assist them in making more informed clinical management decisions.
“This is an exciting time for Ikonisys,” said Dr. Petros Tsipouras, CEO of Ikonisys. “We are generating significant momentum for our new signature test with our first customer and New York State certification. However, even more exciting is the potential clinical value that oncoFISH cervical provides to patients and their physicians.”
About oncoFISH cervical
oncoFISH cervical is a laboratory developed test, intended to be run subsequent to a Pap smear in patients identified to have Low Squamous Intraepithelial Lesions (LSIL). Test results can be used as a differentiator for medical professionals seeking to identify which patients may regress or progress to cervical cancer. Based on this information, physicians and patients can work together to develop early, personalized treatment plans that better address individual needs and ultimately increase chances of survival.
About New England Pathology Associates
NEPA, a seven-member pathology practice, is located on the Springfield, Mass. campus of Mercy Medical Center. NEPA utilizes newly expanded histology and cytopathology laboratories, which it co-owns in an innovative joint venture with Mercy Medical Center.
Founded in 1999, Ikonisys, Inc. is a privately-held, next generation diagnostic company specializing in non-invasive, cell-based diagnostics. Ikonisys has developed the CellOptics® platform, a robotic microscopy technology for fully-automated, high-throughput identification and analysis of rare cells by fluorescence in situ hybridization (FISH). A pipeline of applications is being developed for cancer diagnosis and management (oncoFISH®) and prenatal detection of genetic disorders (fastFISH®) to be run on the Ikoniscope® using the CellOptics technology. Ikonisys’ first proprietary test, oncoFISH cervical, is offered as a Laboratory Developed Test through the company’s CAP accredited clinical laboratory. In addition to oncoFISH cervical, the company offers three FDA-cleared applications that automate certain commercially available FISH tests.
To learn more visit www.ikonisys.com.
Alex Salvi/Renee Viola, 203-776-0791
Louise Mawhinney, 203-776-0791
Source: Ikonisys, Inc.