UDx is the one to watch in Blood based CRC screening not Guardant which sits at 83% sensitivity and 91% specificity !

Signal-C has 93% sensitivity and 92% specificity and it raised US$70M in Q3 2023 to fund its 15,000-patient prospective registration study with FDA.

Labcorp have invested and recently signed a deal for exclusive rights to Genoscopy's ColoSense CRC Dx. Although ColoSense is a stool-based test its clinical performance is outstanding at 94% sensitivity and 88% specificity. It is expecting FDA approval very soon (eg. this current quarter) and this is why Exact Sciences recently tried to sue it to keep it out of the market. ColoSense has better clinical performance than Cologuard (92.3% and 89%)!

Universal DX Announces Strategic Collaboration with Quest Diagnostics to Bring Advanced Colorectal Cancer Screening Blood Test to Patients and Providers in the United States

11/20/2023

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UDX also announces the initial closing of its series B financing of approximately $70 million with investors, including Quest Diagnostics

Financing to support UDX's pursuit of FDA premarket approval for its colorectal cancer screening blood test

CAMBRDIGE, Mass. and SECAUCUS, N.J., Nov. 20, 2023 /PRNewswire/ -- Universal DX ("UDX"), a biotech company on a mission to transform cancer into a curable disease, today announced a strategic collaboration with Quest Diagnostics ("Quest") (NYSE: DGX), the nation's leading provider of diagnostic information services, designed to improve colorectal cancer screening in the United States – for which more than 110 million people may be eligible.ⁱ

Under the commercial agreement between UDX and Quest, Quest plans to perform and provide clinical laboratory services to providers and patients in the United States based on UDX's Signal-C®, an advanced colorectal cancer screening blood test, assuming premarket approval of the test in the United States.

To support a submission to the U.S. Food and Drug Administration for premarket approval, UDX will enroll patients in a 15,000-patient study involving more than 100 investigator sites to develop clinical evidence for the test. Quest's oncology center of excellence in Lewisville, TX, will serve as the single site to support testing for the study. Assuming FDA approval, Quest will have exclusive rights to provide clinical laboratory services in the U.S.

UDX also announced the initial closing of its series B financing of approximately $70 million from investors, including Quest Diagnostics.

The collaboration aims to combine UDX's innovative liquid biopsy screening technology with Quest's expertise and national scale in the United States, which includes broad electronic health record connectivity and health plan relationships as well as approximately 2,100 patient service centers for blood draws. A leader in advanced oncology diagnostics, Quest specializes in testing for inherited genetic disorders and tumor sequencing for colorectal and other cancers.

Signal-C® uses next generation sequencing (NGS) and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the blood stream. In a 1,000-patient study presented at Digestive Disease Week in May 2023, Signal-C® demonstrated 93% sensitivity for colorectal cancer detection, and 54% sensitivity for detection of precancerous lesions (called advanced adenomas) at 92% specificity overall. The ability to identify advanced adenomas in the precancerous stage may help reduce colorectal cancer incidence and mortality.

"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. "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."

"Quest is continually exploring opportunities to serve large unmet clinical needs with new innovations, developed both organically and with third parties," said Kristie Dolan, Vice President and General Manager, Oncology, Quest Diagnostics. "UDX has created a promising method of screening for colorectal cancer with a simple blood test that includes the ability to detect advanced adenomas. We look forward to collaborating with UDX to bring this innovation to the large population of people in the U.S. who are eligible for colorectal cancer screening but currently fail to be screened given the inconvenience of conventional methods."

The Freenome pivotal study results will be the one to watch for blood-based CRC assays. Roche has invested US$250M in Freenome and they have undertaken the largest ever prospective registrational (PREEMPT) study in history which soon reads out

PRESS RELEASE - MAY 10, 2022

Largest Clinical Study Validating a Blood-based Colorectal Screening Test Completes Enrollment

– PREEMPT CRC is Freenome’s registrational study to validate its test for the early detection of cancer

– More than 35,000 participants enrolled and completed with a diverse range of racial, ethnic, and socioeconomic backgrounds

Freenome, a privately held biotech company, announced the completion of enrollment for PREEMPT CRC, the company’s large, prospective study to validate its blood test for colorectal cancer (CRC) screening among average-risk adults.