Universal Diagnostics S.A. ha compartido esto
Universal Diagnostics S.A. announces the completion of the funding required for the Signal-C® FDA premarket approval with existing investors, including Quest Diagnostics, and new investors, including Olympus Innovation Ventures. The clinical trial for Signal-C® (https://lnkd.in/dVxuMvxj) is well underway and recruited its first patient in January 2024. The study is on target to reach its recruiting goal of enrolling at least 15,000 patients across 100 investigator sites. Quest Diagnostics operates an oncology center of excellence in Lewisville, Texas, that will serve as the single site for testing for the trial. The parties announced a collaboration in November 2023 under which Quest will have exclusive rights to provide clinical laboratory services in the U.S. assuming FDA approval for the test. UDX is the provider of the results of the assay through its proprietary cloud solution. Once FDA approved, both parties will commercialize the test. “We are thrilled to announce the start of our FDA validation for Signal-C®,” said Juan Martinez-Barea, Chairman of UDX. “After securing the funding required, and having operationally launched our collaboration with Quest, UDX is one step closer to reaching the market with a non-invasive, highly accurate blood test for screening for colorectal cancer. Early detection is crucial, and our technology has the potential to significantly reduce the mortality of this disease.” #liquidbiopsy #FDA #PROMISE #SignalC #colorectalcancer #screening #earlydetection