• 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."

Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the U.S. In 2023, an estimated 153,020 people will be diagnosed with colorectal cancer in the U.S. and 52,550 people will die from the disease, according to the American Cancer Society. Screening can help detect the disease in early, treatable stages. However, according to a 2021 National Health Interview Survey, only 59% of individuals aged 45 years and older were up to date on colorectal cancer screening in 2021.

About Quest Diagnostics

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.

About Universal DX

Universal DX is a biotech Company incorporated in Spain in 2012, with headquarters in Madrid (Spain), and main offices in Liubliana (Eslovenia), and Cambridge (Boston). Its mission is to transform Cancer into a curable disease by detecting it early.

With its multi-omics + computational biology + AI tools, it is cracking the code to "true" early Cancer detection, having identified the specific cfDNA sequence regions that capture Cancer's earliest signal.

The company's is currently focused on Colorectal-Cancer, but its technology and platform allow to identify the unique DNA sequence regions associated with other high-burden Cancers, such as Lung, Pancreatic, Liver or Esophagus, with high sensitivity and tissue-of-origin specificity.

For more information about the company, visit https://www.universaldx.com/.

ⁱ Based on U.S. Census population estimates and colorectal cancer screening eligibility as characterized by the USPSTF.