Universal Diagnostics S.L. (UDX) is a European diagnostics company developing blood-based solutions for detecting cancer early when treatment options are more plentiful. The assays rely on a curated set of proprietary methylation marker panels; a simple blood sample collected as part of a routine check-up, can be processed using standard equipment. The Company’s first test will be a screening test able to detect colorectal cancer and the pre-cancer stage, thus avoiding cancer. The company has raised $30M and has 25 employees.
Current Status
Universal DX is about to finish its colorectal cancer and advanced adenoma screening test. The test will reduce incidence from and mortality of colorectal cancer at massive global scale. We have presented our results at various leading conferences in the US (e.g. AACR 01/2020) and Europe (e.g. ESMO GI 07/20, ESMO Annual 09/20), are support by >80 hospitals in 6 countries (incl. US) and a world-class scientific board. In addition, we have just presented at ESMO Annual in 09/20 data for lung, pancreatic, and breast cancer tests. This shows the potential of one day taking a simple blood sample and test for various types of cancer. We have raised roughly $30M so far.
Market
Men and women >50 years old worldwide; we estimate that this is 350M people only in US/Europe/Middle East
Problem or Opportunity
Our mission is to make cancer a curable disease by detecting it early or preventing it in the first place. Our total addressable market is conservatively speaking >350MK people.
Solution (product or service)
Our Tests will detect - the pre-cancer stage of cancer, therefore preventing the development of cancer - and the early (and late) stage of cancer, when treatment options are more plentiful and much more likely to succeed
We will do this via a simple blood based test that can be analyzed with commercially available equipment.
Competitors
Commercially available tests are Cologuard (fecal test by Exact Sciences) and EpiProColon (blood based test by Epigenomics) . Cologuard reaches high accuracy, but is a fecal test and hence suffers from low patient compliance. . EpiProcolon has low accuracy, hence is not successfully commercialized The UDX test is significantly more accurate than both of these tests
Exact Sciences, as 1 colorectal cancer screening test company with inferior accuracy than UDX and a fecal test (lower patient compliance) is valued US$>13B. This underlines the Unicorn Potential of Universal DX
Advantages or differentiators
Our colorectal cancer and advanced adenoma test as two main advantages . Colorectal cancer detection accuracy is higher than any commercially available test . Advanced Adenoma (pre-cancer) detection accuracy is unique, no one else has that. . Blood based test (e.g. not fecal test or colonoscopy) . The health economics of the UDX makes it a clear business case . Scaleable as commercially available equipment is used . UDX technology platform applicable for other cancers, too
Finance
Revenues will come by numbers of tests sold. 2022: $3M 2023: $4M ... 2026: $200M (with reimbursed sales) EBITDA margin ~50%
Business model
We will sell the test in the . private market (starting point) with the help of clinical labs, private hospitals, private insurance companies as well as companies that offer their employees an annual health check . private market (build up in parallel) where we will work with public health systems to integrate the UDX test into the existing public screening programs in order to have the test reimbursed. The test will be delivered via a . commercial blood draw . that will be analyzed in a clinical lab with commercially available equipment . the raw data fr om the lab will be uploaded in the UDX cloud wh ere the algorithm will analyze the biomarkers detected . and provide the test result.
Money will be spent on
Finalization of colorectal cancer and advanced adenoma test Commercialization Development other cancers Company building
. Clinical trial risk due to COVID19 - we mitigate by rigorous site selection . Competitive environment risk - we differentiate with Advanced Adenoma detection
Incubation/Acceleration programs accomplishment
Johnson & Johnson Incubator Program San Francisco 2015-17
Won the competition and other awards
"Most disrupted startup" at Singularity University Health Conference in San Diego
Invention/Patent
Universal DX has 2 approved patents and 6 pending patent applications.