A Medical Device Daily

Xenomics (New York), a developer of next-generation medical DNA technologies, has executed a contract with North Shore-Long Island Jewish Health System (LIJ), one of the nation’s largest healthcare institutions, to begin conducting human clinical studies in the next development phase of the company’s Transrenal-DNA (Tr-DNA) technology.

The study will test the technology’s ability to non-invasively detect Down syndrome in unborn babies using a simple urine collection from the mother. Under the research agreement, which is subject to institutional review board approval, Xenomics and North Shore-LIJ will collaborate to begin human clinical studies of the company’s safe, inexpensive and non-invasive medical tests to detect Down syndrome.

North Shore-LIJ, a 14-hospital network serving Long Island, Queens and Staten Island that treats a large population of high-risk pregnancy patients, will provide Xenomics scientists with anonymous urine samples from expectant mothers carrying children identified with Down syndrome. That will enable Xenomics to conduct the next phase of clinical studies as it develops its technology for the diagnostic marketplace.

“The agreement with North Shore-LIJ will give us access to human clinical samples and outcome data, which are required by the FDA in the development of any new commercial diagnostic product. As such, it represents a critical turning point in our timeline to develop commercially available prenatal genetic tests for Down syndrome using our Tr-DNA technology,” said Dr. Randy White, CEO of Xenomics.

Ohio State University College of Medicine (Columbus, Ohio) and BioImagene (San Mateo, California) said they have signed an agreement to engage in numerous collaborative activities, including joint research proposals at the state and national levels, joint projects “with profit potential,” and other mutually beneficial activities.

The collaborative program is to be undertaken by the department of pathology, under the leadership of Sanford Barsky, MD, professor and Senhauser chair in the department, who has teamed up with BioImagene to develop digital pathology as both a research as well as a diagnostic tool.

“This collaboration combines the pathology experience of Ohio Sate and its unique patient database with the computer software imaging expertise of BioImagene to develop and validate imaging algorithms that can be applied to various areas of anatomical pathology, including tissue microarray interpretation, immunocytochemistry, in situ hybridization, and hematoxylin and eosin-based diagnosis,” Barsky said.

“In order to develop a comprehensive solution, we needed access to a vast number of tissue samples, clinical data, outcome data and the deep domain knowledge with the experts to validate our result,” said Mohan Uttarwar, president and CEO of BioImagene.