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Universal DX Closes Series B Round to Begin Clinical Trial for CRC Screening Test

NEW YORK – Spanish diagnostic firm Universal DX announced Thursday that it has closed a Series B financing round that will be used fund the clinical trial for US Food and Drug Administration approval of its blood-based colorectal cancer screening test.

The financing round, which was an extension of the $70 million Series B round the firm announced in November, raised an undisclosed amount and included new investors, such as Olympus Innovation Ventures, and existing investors like Quest Diagnostics. Quest's oncology center in Lewisville, Texas, will be the single testing site for the clinical trial, and if the test, called Signal-C, receives FDA approval, both Quest and Universal DX will commercialize the test.

The trial recruited its first patient in January and is on target to reach its goal of enrolling at least 15,000 patients across 100 investigator sites, Universal DX said in a statement.

The Signal-C test leverages next-generation sequencing and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in a patient's bloodstream.

"After securing the funding required, and having operationally launched our collaboration with Quest, UDX is one step closer to reaching the market with a noninvasive, highly accurate blood test for screening for colorectal cancer," Universal DX Chairman Juan Martinez-Barea said in a statement. "Early detection is crucial, and our technology has the potential to significantly reduce the mortality of this disease."