Revenue for OneTest, our patented multi-cancer blood test, increased significantly in the first half of 2024 compared to the same period from last year, rising from $360,000 in 1H'23 to $867,000 in 1H'24. Approximately 60% of test orders came from new customers, with the remaining 40% being reorders from previous purchasers. Notably, over one-third of entities that purchased OneTest for their employees re-ordered within about 18 months.

Earlier this year, we participated in a blinded evaluation of our MCED conducted by the U.S. National Cancer Institute (NCI) using blood specimens from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. These specimens, collected from asymptomatic individuals, are considered a gold standard for assessing a test's real-world screening performance in healthy people.

The bar graph below, prepared by NCI scientists, shows that our test correctly identified half of early-stage pancreatic, ovarian, and prostate cancers, and nearly one-third of early-stage lung cancers. In contrast, published data from Grail suggest their Galleri test has considerably lower sensitivity with early-stage cancer.

(Click Graph To Enlarge)

In July, we secured our first major software-as-a-service (SaaS) license agreement with HealthLeader of Taiwan. HealthLeader collaborates with several TAF-certified medical laboratories that serve approximately 3,000 clinics in Taiwan, reaching over 3 million people. Under this agreement, HealthLeader will integrate 20/20 GeneSystems' OneTest™ technology into its offerings. This partnership will expand access to early cancer detection in Taiwan through advanced algorithms and multi-biomarker analysis and help grow our international business.

Click here to view our press release about this exciting news.

Legislation to permit eventual Medicare coverage of multi-cancer tests like 20/20’s OneTest cleared a key hurdle in the House of Representatives. H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act, was marked up and passed by the House Ways and Means Committee on June 27 by a unanimous, bipartisan vote of 38-0. A press release describing this development may be viewed here.  

OneTest is one of only two Multi-Cancer Early Detection (MCED) tests currently being actively marketed in the U.S. Significant bipartisan support for these tests in Congress gives us confidence that they will be widely adopted and paid for over the years to come. We plan to leverage data such as that supplied by the U.S. National Cancer Institute (presented above) to eventually convince payers to cover our MCED.

Last month, a second U.S. patent issued covering our MCED. The claims broadly cover AI or machine learning approaches used with various protein tumor markers with an algorithm developed or trained with large numbers of patient records from a clinical study or real-world use. Patents are also expected to issue over the coming months in China, Japan, and Canada covering our MCED or our lung cancer test panel.