COMPANY:

DiaCarta

"DiaCarta...announced that Florida Health Department selected 'using plasma DNA concentration (DiaCarta’s RadTox™ test) for early detection of treatment response and resistance' through the Casey DeSantis Florida Cancer Innovation Fund. This fund supports deployment of the RadTox™ test throughout the State of Florida to be performed between Radiotherapy or Chemotherapy doses for real time detection of treatment response or resistance. The results will be as a real time predictor of imaging data."

"DiaCarta proudly announced that the Oncuria Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024...Oncuria-Detect: Designed for the detection of bladder cancer, providing accurate and reliable results to aid in early diagnosis and treatment planning; Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance; Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies."

"DiaCarta...today announced that it has established a strategic collaboration with OncoAssure...The focus of the collaboration is to commercialize OncoAssure’s groundbreaking Prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment."

"DiaCarta...announced that its revolutionary RadTox™ test, designed for tumor response monitoring, is now eligible for reimbursement from Medicare, effective January 1, 2024."

"DiaCarta...announced today that DiaCarta received US FDA 510(k) clearance for it’s over the counter (OTC) at home iColon Fecal Occult Blood Test (FOBT) that enables early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer."

"AnchorDx said Monday that it has entered into a long-term collaboration with DiaCarta aimed at product development and global commercialization in the cancer screening space...Under the agreement, AnchorDx and DiaCarta will leverage proprietary technologies for DNA methylation and mutation detection that each company has developed...The firm is currently conducting a registrational and prospective clinical trial for the urine-based assay, dubbed UriFind, and Pleasanton, California-based DiaCarta will serve as one of the clinical testing laboratories."

"DiaCarta...announced that it has received accreditation by the College of American Pathologists (CAP) for its CLIA certified lab. This accreditation is awarded to facilities that meet the high standards of quality, accuracy, and consistency in laboratory services required by CAP and underscores DiaCarta’s leadership and commitment to excellence."

"The presentations will focus on how XNA can be used to improve the assay sensitivity of different technology platforms such as Sanger sequencing, qPCR, and Next Generation Sequencing (NGS). DiaCarta’s XNA technology has demonstrated improvements to the sensitivity of traditional Sanger sequencing to comparable sensitivity levels of NGS, with much broader clinical utility and lower cost. The XNA-based Sanger sequencing and qPCR are used for sensitive companion diagnostics (CDx) assay development for identification of KRAS G12C mutation."

"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."