The Signal-C test leverages NGS and bioinformatics to detect methylated DNA patterns and fragments shed by colorectal cancer tumours circulating in the blood stream. Credit: Tatiana from Pixabay.

Universal DX (UDX) and Quest Diagnostics have signed a commercial agreement for an advanced colorectal cancer screening blood test in the US.

Under the collaboration, Quest plans to conduct and offer clinical laboratory services to healthcare providers and patients using UDX’s Signal-C colorectal cancer screening blood test upon receiving premarket approval in the country.

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Leveraging next-generation sequencing (NGS) and bioinformatics, the Signal-C test will detect methylated DNA patterns and fragments released by colorectal cancer tumours that circulate in the bloodstream.

UDX will conduct a study with 15,000 patients across more than 100 investigator sites to gather clinical evidence for the test in preparation for submitting it to the US Food and Drug Administration (FDA) for premarket approval.

Quest’s oncology centre of excellence, located in Lewisville, Texas, will be the single site for conducting tests related to the study.

Quest will hold exclusive rights to offer clinical laboratory services in the US after the FDA approves the test.

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The collaboration intends to integrate UDX’s liquid biopsy screening technology with Quest’s expertise and national scale in the country, which comprises a wider electronic health record connectivity and health plan relationships and roughly 2,100 patient service centres for blood draws.

UDX chairman Juan Martinez Barea said: “At UDX, we believe that early detection is the key to create a future where cancer is curable.

“This collaboration will make it more likely that patients in the US will, over time, have a convenient, quality and accessible option to screen for colorectal cancer.”

UDX has also completed the initial phase of its series B financing, securing approximately $70m from investors, with Quest Diagnostics among them.