DiaCarta, Inc. announced that DiaCarta received US FDA 510 clearance for it’s over the counter at home iColon Fecal Occult Blood Test that enables early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer.
PLEASANTON, Calif., Dec. 5, 2023 /PRNewswire/ -- DiaCarta, Inc., 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.
About DiaCarta
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
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SOURCE DiaCarta Inc
