Quest, Universal DX Collaborate to Advance Colorectal Cancer Screening

On November 20, 2023, Universal DX (UDX), a biotechnology company, announced its collaboration with Quest Diagnostics, one of the two most significant lab services in the United States, to study, submit, and launch a blood-based screening test for colorectal cancer.

The companies are collaborating to submit data to the US Food and Drug Administration (FDA) for premarket approval. The submission will include data from a clinical trial that UDX is conducting. The company plans to gather data from 15,000 patients across 100 clinical trial sites to support premarket approval for the biotechnology. 

According to the press release, the two companies have entered a commercial agreement which, upon premarket approval from the FDA, will allow Quest to perform colorectal cancer screenings for providers and patients using the UDX Signal-C colorectal cancer screening blood test.

The Signal-C test is a next-generation sequencing and bioinformatic examination that detects methylated DNA from circulating colorectal cancer tumors. Although large-scale studies are needed to confirm the test’s usability, UDX conducted a study on 1,000 patients that indicated a 93% sensitivity rate for colorectal cancer detection and a 92% specificity. However, the sensitivity for advanced adenomas was remarkably lower at 54%.

As the researchers gather more data on the test and its validity, the companies anticipate that this tool will have significant public health benefits.

Recent insights into colorectal cancer have indicated rising rates of the condition, making it the third deadliest cancer in the US. According to a report published in CA: A Cancer Journal for Clinicians by the American Cancer Society, colorectal cancer rates in individuals under 55 have grown by 1–2% annually since the 1990s. 

Currently, the gold standard for colorectal cancer screening is a colonoscopy; however, the procedure is invasive, which deters patients from getting screened on time. Although other screening methods exist, such as stool-based and radiological screenings, colonoscopies are more reliable.

Adding a new test to the arsenal of diagnostic tools for colorectal cancer may improve early diagnosis and contribute to scientific advancements for reliable, minimally invasive colorectal cancer screenings.

"Quest Diagnostics has the leading expertise in oncology and national scale to harness our Signal-C technology to make it broadly accessible in the United States," said Juan Martinez Barea, Chairman of UDX, in the press release. "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 United States will, over time, have a convenient, quality, and accessible option to screen for colorectal cancer."