COMPANY:

DiaCarta

"DiaCarta, Ltd...announced the successful completion of the validation study of Oncuria^® multiplex bladder cancer immunoassay as a laboratory developed test ('LDT'). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California."

"DiaCarta...announced that the company, under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, will collaborate on the evaluation and development of DiaCarta's proprietary xeno-nucleic acid (XNA) molecular clamping technology. NCI and DiaCarta will collaborate on the following projects: (1) the investigation of low frequency mutation events in cancers and rare diseases using DiaCarta's proprietary xeno-nucleic acid (XNA) molecular clamping technology, and (2) the development of XNA probes for in situ cancer cell detection. The duration of the CRADA will be 2 years from the effective start date."

"In this study, a total of 380 clinical samples, including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC, were analyzed with the ColoScape™ assay. With liquid biopsy the preliminary assay clinical specificity for CRC was 100% and the clinical sensitivity was 92.2%; for precancerous lesions clinical specificity was 95% and clinical sensitivity was 62.5%. With FFPE samples the preliminary assay clinical specificity for CRC was 96% and the clinical sensitivity was 92%, making this assay robust, specific and highly sensitive."