DiaCarta Launches OTC at Home Fecal Occult Blood Test to Complement its ColoScape™ Test
DiaCarta, Ltd. (“DiaCarta”), a leading innovator in precision medicine diagnostic biomarker assays, 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.
Colorectal cancer is the third most frequent cancer worldwide, emphasizing the critical need for early and effective diagnostic screening methods. DiaCarta is at the forefront of meeting this challenge with the introduction of its advanced iColon FOBT, offering a non-invasive product for early detection of blood in stool at home. The iColon FOBT complements DiaCarta’s highly sensitive ColoScape™ Test for qualitative early detection of colorectal cancer-associated mutation and methylation diagnostic biomarkers in circulating blood. The ColoScape test can be used to identify patients at high risk for colorectal cancer that generally require follow-up diagnostic evaluations by colonoscopy and imaging.
“We are excited to introduce our Fecal Occult Blood Test as a significant leap forward in the field of colorectal cancer screening,” said Adam (Aiguo) Zhang CEO of DiaCarta. “Our commitment to advancing healthcare through innovation is evident in the development of this FOBT, which has the potential to save lives by enabling early detection and intervention.
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. DiaCarta’s novel Xeno Nucleic Acid (XNA) qPCR technology provides a high level of sensitivity, as the XNA tightly binds and blocks amplification of wild-type sequence, which enables only the mutant target sequence to be amplified. Using XNA technology, DiaCarta has developed its ColoScape™ colorectal cancer mutation test that is highly sensitive to Advanced Adenomas. Powered by its isobDNA™ technology that provides a high level of detection as it amplifies the signal and requires no RNA/DNA extraction or amplification, the company has developed its RadTox™ test that monitors circulating cell-free DNA. This revolutionary test personalizes radiation and chemotherapy by enabling assessment of tumor response, mitigation of adverse events thereby enhancing patient care. Based in Pleasanton, California, DiaCarta is ISO13485 certified, GMP-compliant, and offers CLIA certified, CAP accredited laboratory services to its customers. www.diacarta.com
DiaCarta, a leading molecular diagnostics company personalizing patient care through liquid biopsy, proudly announced that its revolutionary RadTox™ test, designed for tumor response monitoring, is now eligible for reimbursement from Medicare, effective January 1, 2024.
DiaCarta and HMC/HML Team up for Customizing Lab Development Test Validations and Compliances in the US Market
DiaCarta announced that the company has formed strategic partnership with Hopkins MedTech Compliance and Hopkins MedTech Lab Services.
DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced the termination of its Business Combination Agreement with HH&L Acquisition Co.
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.
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.