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.
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
Contacts
DiaCarta:
Dr. Anne Vallerga
VP, External Affairs
Anne.k@diacarta.com
www.diacarta.com
Florida Selects DiaCarta’s cfDNA Test (RadTox™) for Statewide Use to Detect Early Response of Cancer Treatment
DiaCarta, a leading molecular diagnostics company specializing in personalized patient care through liquid biopsy, proudly 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 Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024
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.
DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test
DiaCarta, Inc. (“DiaCarta”), a pioneer in molecular diagnostic test development for cancer and infectious diseases, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company. 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’s RadTox™ Test to Monitor Tumor Response Receives Medicare Coverage
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.