'HH&L Acquisition Co SPAC Merger Company DiaCarta Gets FDA Emergency Use Authorization For Its Quantivirus Monkeypox Test Kit' - FDA
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PLEASNTON, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- DiaCarta, Ltd. ("DiaCarta"), a novel molecular diagnostic test developer for cancer and infectious diseases, today 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. "This CAP Accreditation is a tremendous accomplishment that signifies DiaCarta's commitment to excellence and I am proud of our team's dedication in support this major milestone," said Zheng
Abstracts demonstrating XNA technology's improvements to assay sensitivity across different technology platforms and support for use in companion diagnostics (CDx) assay developmentAdditional abstracts to further support XNA technology's potential for use in minimal residual disease (MRD) monitoring of residual cancer cells PLEASANTON, Calif., April 16, 2023 (GLOBE NEWSWIRE) -- DiaCarta, Ltd. ("DiaCarta"), a precision molecular diagnostics company, today announced that it will present five data posters at the American Association of Cancer Research (AACR) Annual Meeting 2023, which convenes in Orlando, Florida from April 14-19, 2023. The presentations will focus on how XNA can be used to
PLEASANTON, Calif., Jan. 12, 2023 (GLOBE NEWSWIRE) -- DiaCarta, Ltd. ("DiaCarta"), a precision molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its QuantiVirusTM MPXV test, which is a PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection. The test is designed for use by authorized laboratories on the most popular qPCR instruments, including the Thermo Fisher (ABI) QuantStudio5, Thermo Fisher (ABI) 7500 Fast Dx, Bio-Rad CFX384, and Roche LightCycler 480 II Systems. QuantiVirusTM MPXV test targets two di
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- SEC Filing
https://www.fda.gov/media/164470/download