At FDIC International 2023, we met with OneTest™ Cancer’s David Lees as he introduces this incredibly important early-detection cancer test.
OneTest™ is a multi-cancer early detection (MCED) blood test that predicts an individual’s risk of being identified as having cancer in the coming 12-month period.
For most cancers, early detection can save lives. OneTest™ is one of the most affordable tool to help detect cancers early.
Recent studies have demonstrated that genetics only accounts for around 5% of cancers.
Those concerned about their risk of cancer, even with little or no family history may benefit from routine cancer marker testing. This approach has become standard practice in Japan, Korea, China and throughout East Asia where nearly all adults receive checkups that include many of the biomarkers in OneTest™.
An MCED is a blood test that detects and analyzes the levels of multiple biomarkers (DNA or protein) that signal the presence of many types of cancer. The goal of an MCED is to detect a cancer early, before symptoms appear as earlier intervention often results in better outcomes.
In 2022 MCEDs became a key component of President Biden’s “Cancer Moonshot” program. As a result, the U.S. National Cancer Institute plans to support large population studies of MCEDs beginning in 2024. (https://prevention.cancer.gov/major-programs/mcd).
How is OneTest™ different from other MCEDs?
MCEDs are a relatively new type of cancer screening approach that began to enter the market in 2019 and 2020. Most MCEDs measure circulating tumor DNA (ctDNA). 20/20’s OneTest for Cancer, in contrast, measures tumor antigens, proteins that tumor cells release in the bloodstream or present on their surface that are recognized by the immune system
These protein biomarkers have FDA-approved in-vitro diagnostic (IVD) test kits available through major US diagnostic manufacturers. The use of FDA-approved tests, run in a CLIA certified laboratory, ensures the analytical performance of these tests. Furthermore, by using these off-the-shelf individual tests, the costs of OneTest™ can be kept to a minimum making it one of the most affordable MCEDs on the market.
Unlike most other available MCEDs, OneTest™ was developed in an entirely asymptomatic, real-world cohort of individuals, meaning that at the time of testing patients were not known to have cancer and all identified cancers were detected in the post-test period.
Most developers use known cases of disease for test development which allows them to use smaller study cohorts. This later approach may result in biomarker signatures that have greater ability to differentiate between cancer and non-cancer (greater sensitivity and specificity), but less overall utility, as they do not detect cancer as early.
OneTest™ measures a panel of tumor markers including AFP, CEA, CA19-9, CYFRA21-1, and PSA for males and AFP, CEA, CA19-9, CYFRA21-1, CA125, and CA15-3 for females. These biomarkers are well known and established in the oncology field, yet with the exception of PSA for prostate cancer, are generally considered insufficient for cancer diagnosis on their own and are primarily used only for monitoring effectivity of cancer therapy and/or for detecting disease recurrence. Each of the markers are known to be elevated in specific cancer types, yet their levels are not always consistent and may vary from patient to patient. The cancers associated with these markers include over 20 of the most commonly occurring cancers (e.g. lung, liver, colon, prostate, breast, etc.).
Learn more at https://onetestforcancer.com.
