Universal DX Initiates Clinical Trial for FDA Approval of Signal-C® Colorectal Cancer Screening Blood Test

Completes funding required for the Signal-C® FDA premarket approval with existing investors, including Quest Diagnostics, and new investors, including Olympus Innovation Ventures

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Universal DX (“UDX”), a biotech company dedicated to transforming cancer into a curable disease by detecting it early, today announced closure of the Series B which funds the clinical trial for its colorectal cancer screening blood test, Signal-C®, aimed at achieving FDA premarket approval.

The clinical trial for Signal-C® (https://clinicaltrials.gov/study/NCT06059963) is well under way 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.”

Signal-C® uses next-generation sequencing (NGS) and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the bloodstream. The UDX Signal-C® test has repeatedly demonstrated high accuracy as shown in studies presented at ASCO GI 2023 and Digestive Disease Week 2023.

Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the U.S. In 2023, an estimated 153,020 people were diagnosed with colorectal cancer in the U.S., and 52,550 died from the disease, according to the American Cancer Society. Screening can help detect the disease in its early, more treatable stages. However, according to a 2021 National Health Interview Survey, only 59% of individuals aged 45 years and older were up to date on colorectal cancer screening mainly due to relatively low compliance rates of existing screening techniques. It is expected that simple and non-intrusive blood tests will significantly increase the percentage of individuals screened, reduce the mortality rate and, consequently, help save more lives.

About Universal DX

Universal DX is a biotech company headquartered in Spain with its US office in Cambridge (Boston). Its mission is to transform cancer into a curable disease by detecting it early. Utilizing multi-omics, computational biology, and AI tools, UDX is deciphering the unique cfDNA sequences that capture cancer’s earliest signals. UDX’s most advanced assay is for colorectal cancer screening with high accuracy for pre-cancer and cancers. The company’s technology can also be applied to other high-burden cancers. UDX has presented data on lung, pancreatic, liver, and esophageal cancers.

For more information about the company, visit www.universaldx.com.