PreCyte Announces $300k SBIR Phase I Funding for the Application of the Indicator Cell Assay Platform (iCAP) for the Classification of Indeterminate Pulmonary Nodules

SEATTLE, WA, Jan. 05, 2016 – PreCyte, Inc. a developer of innovative diagnostic tests for neurodegenerative and other diseases, and the Institute for Systems Biology (ISB) announced today that the National Cancer Institute of the National Institutes of Health (NIH) has awarded PreCyte a Small Business Innovation Research (SBIR) grant to support application of the company's targeted diagnostic technology, based on the Indicator Cell Assay Platform (ICAP) applied to serum, for classification of benign pulmonary nodules. The award will provide PreCyte with approximately $300k over one year. In the previous studies performed by PreCyte and its collaborators at ISB, and supported in part by the National Institute of Aging and Washington State’s Life Sciences Discovery Fund (LSDF), prodromal Alzheimer’s, MCI, and Alzheimer's disease were differentiated from healthy controls. The present award will support application of the iCAP and analysis of archived and prospectively collected serum samples; the analysis will be conducted in collaboration with ISB and leading academic centers. 

"There is a great clinical need to develop minimally invasive and effective methods to identify individuals, who present with indeterminate pulmonary nodules (too large to ignore and too small to be obvious surgical candidates), whose nodules are not lung cancer,” said Robert Lipshutz, PhD, CEO of PreCyte. “Accurate identification of patients with benign nodules would enable them to avoid costly and risky follow-up procedures including resection or trans-thoracic biopsies.  We greatly appreciate the additional support of the NIH. This funding strengthens our ability to collaborate with key opinion leaders in the field of lung cancer, and to further demonstrate the broad applicability of the iCAP assay. We look forward to our continued collaboration with ISB and other leading clinical centers.” 

“We are thrilled about the opportunity to make an impact in lung cancer and other neurodegenerative diseases, and look forward to working with PreCyte on this exciting project, said Prof. John Aitchison, Ph.D., founding faculty member at ISB.

About iCAP. 

The indicator cell assay platform (iCAP) is analogous to the early pregnancy test in which, without knowing what to look for, the patient’s blood or urine was injected into a rabbit and readout was the response of the rabbit’s ovaries to the sample. In the iCAP, patient serum is applied to specifically selected standardized indicator cells. The response of the cell provides the readout. The indicator cell assay will succeed where other methods have failed by exploiting cells’ natural capability to amplify and integrate multi-analyte signals. The assay has been demonstrated to be >90% sensitive and specific for the detection of early stage AD in human samples in a murine model.

About PreCyte

PreCyte is a privately held molecular diagnostics company focused on developing minimally invasive tests for the early detection and monitoring of neurodegenerative disease and cancer.   PreCyte was previously awarded a direct to Phase II SBIR by the National Institute of Aging for the optimization and validation of an iCAP assay for the early detection of Alzheimer’s disease.

Please Note: This news release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the results, timing, costs and regulatory review of our studies and clinical trials; the results of studies of our product candidates conducted by others; our ability to obtain future funding on acceptable terms; our ability to obtain regulatory approval of our product candidates; the possible impairment of, or inability to obtain, intellectual property rights; and innovation by our competitors. The content is solely the responsibility of the company and does not necessarily represent the official views of the National Institutes of Health.