Universal DX, a Spanish biotech company aiming to make cancer curable with early screening, made two significant announcements last month.
First, its strategic partnership with Quest Diagnostics, America’s leading provider of diagnostic services, to enter the US market.
Second, it closed the series B funding round by raising $70 million from Quest Diagnostics and other investors.
Let’s dive into how these will help Universal DX establish itself in the US market.
Universal DX and Signal-C
Universal DX (UDX) is transforming how cancer is screened by developing a cancer platform using minimally invasive liquid biopsy screening technology to detect cancer in the early stages.
The company combines multi-omics, computational biology and machine learning to capture the signals of high-burden gastrointestinal cancers. Its first proprietary tool is Signal-C.
Signal-C is UDX’s advanced blood test to screen colorectal cancer. It can detect colorectal cancer with 93% sensitivity and 92% specificity. Colorectal cancer, also known as colon cancer, is the third most commonly diagnosed cancer in the US. It is also the third leading cause of death in men and women in the US.
How does Signal-C work?
Colorectal cancer tumours shed methylated DNA patterns and fragments in the bloodstream. Signal-C uses next-generation sequencing and bioinformatics to detect these fragments from a patient’s blood.
As a result, colorectal cancer can be detected in the early stages, when there are several treatment options available. Cancer treatment options reduce as the cancer stage advances. Early detection helps in making cancer curable and reducing its burden.
Universal DX and Quest Diagnostics partnership
As a part of their strategic collaboration, Quest Diagnostics will provide clinical laboratory services to patients in the US based on UDX’s Signal-C.
Once UDX receives premarket approval from the FDA, Quest Diagnostics will collaborate with UDX to perform a 15,000-patient study to develop clinical evidence for the test. Quest’s oncology centre in Lewisville, TX, will be the single site to support testing for the study.
After the FDA approves the test, Quest will hold exclusive rights to provide UDX’s Signal-C in the US.
“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.
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.”
– Juan Martinez Barea, Chairman of UDX.
This collaboration will combine UDX’s innovative blood-based cancer screening technology with Quest’s experience and national scale in the US. Quest is America’s leading oncology diagnostics company specialising in testing for genetic disorders and cancer tumour sequencing.
Way ahead for Universal DX
UDX offers one-of-its-kind blood-based cancer screening tests, which can be accessible and affordable across populations. The initial 1000-patient study conducted by UDX for its colorectal cancer screening test, Signal-C, demonstrated excellent results.
However, to gain FDA approval and demonstrate the test’s effectiveness across the global population, UDX plans to conduct a larger 15,000-patient study involving over 100 investigator sites.
By joining hands with Quest Diagnostics, UDX has paved its way into the US market. Quest’s expertise in cancer testing, broad health record connectivity, health plan relationships and 2100 patient service centres for blood draws will ensure UDX’s innovative cancer screening reaches the wider US population.
Once UDX’s Signal-C gets approval, it will work on bringing its gastrointestinal cancer screening tests, including Signal-P (pancreatic), Signal-L (liver), Signal-LU (lung), and Signal-G (gastric/stomach), to the market.
With innovative tests in its arsenal and experienced associate to guide the way forward, UDX is bound to transform the way we look at cancer diagnostics and treatment.
“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.” .
–Kristie Dolan, Vice President and General Manager, Oncology, Quest Diagnostics
What do you think? Let us know in the comments.
