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DiaCarta, a precision molecular diagnostics company, is set to present five data posters at the AACR Annual Meeting 2023 in Orlando, Florida. The focus will be on its innovative XNA technology, which enhances assay sensitivity for various platforms, including Sanger sequencing and NGS, at lower costs. The technology supports companion diagnostics for the KRAS G12C mutation, relevant for targeted therapies LUMAKRAS™ and KRAZATI™ approved for NSCLC patients. DiaCarta aims to leverage its XNA technology for early cancer detection and monitoring minimal residual disease (MRD), addressing challenges faced with current ultra-deep sequencing methods. The posters will be accessible on DiaCarta’s website post-presentation.
DiaCarta, a precision molecular diagnostics company, received Emergency Use Authorization (EUA) from the FDA for its QuantiVirus MPXV test, designed to detect monkeypox virus DNA in lesion swabs. This PCR test can be utilized on several popular qPCR instruments and targets two regions of the MPXV genome, enhancing its mutation resistance. The high-throughput solution facilitates lab adoption, ensuring quick and accurate results for patients. DiaCarta's CEO emphasized their rapid response to the monkeypox outbreak, underscoring the test's reliability and accessibility.
DiaCarta, a precision molecular diagnostics company, has successfully validated its Oncuria bladder cancer test, now receiving patient samples in its CLIA lab. This multiplex immunoassay demonstrates 93% sensitivity and 93% specificity in detecting bladder cancer. Oncuria aims to enhance early detection and treatment monitoring, particularly for low-grade tumors. It received Breakthrough Device Designation from the FDA in 2021. The American Medical Association has established CPT codes for Oncuria effective January 1, 2023, as DiaCarta works towards regulatory approvals in the U.S. and China.
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