Universal DX nabs $70 million, inks deal with Quest for colorectal cancer screening

Universal DX (UDX) on Monday announced it has closed a roughly $70 million Series B funding round. Investors backing the financing include Quest Diagnostics, which has teamed up with the Spanish liquid biopsy company to improve colorectal cancer screening in the US.

"UDX has created a promising method of screening for colorectal cancer with a simple blood test that includes the ability to detect advanced adenomas," remarked Kristie Dolan, vice president and general manager of oncology at Quest. She said the company looks forward to working with UDX "to bring this innovation to the large population of people in the US who are eligible for colorectal cancer screening but currently fail to be screened given the inconvenience of conventional methods."

Under the deal, Quest will perform and provide clinical laboratory services to providers and patients in the US based on UDX's advanced colorectal cancer screening blood test, Signal-C, assuming it receives premarket approval in the country. The agreement will combine UDX's liquid biopsy screening technology with Quest's expertise and national scale in the US, which the partners say includes broad electronic health record connectivity and health plan relationships, along with approximately 2100 patient service centres for blood draws. 

93% sensitivity

Signal-C works by using next generation sequencing and bioinformatics to detect methylated DNA patterns and fragments shed by colorectal cancer tumours circulating in the bloodstream. In a 1,000-patient study presented at Digestive Disease Week in May, Signal-C demonstrated 93% sensitivity when detecting colorectal cancer, and 54% sensitivity for detecting advanced adenomas at 92% specificity overall. 

UDX will use the funding to pursue FDA premarket approval for Signal-C. To support its submission to the regulator, the company will conduct a 15,000-patient study which will involve over 100 investigator sites to develop clinical evidence for the blood test. Quest's oncology centre in Lewisville, Texas will serve as the single site to support testing for the study. If cleared by the FDA, Quest will gain exclusive rights to provide clinical laboratory services in the US.

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