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An increasing number of blood-based single cancer early detection (SCED) tests are being developed to provide a convenient and accessible means of screening with the potential to improve the early detection of an individual cancer, including lung cancer. The 18th annual Next Generation Dx Summit held August 24-26, 2026, in Washington, DC, featured a program dedicated to SCEDs, providing a venue for the presentation of performance data, multistakeholder discussions on considerations for their appropriate validation and clinical implementation, and key differences between SCED and multi-cancer early detection (MCED) tests.
Advancing Personalized Cancer Detection
Throughout the meeting, representatives from diagnostics companies presented data on the performance of various SCED tests being developed for different types of cancer and leveraging a variety of different analytes including circulating tumor DNA (ctDNA), RNA, proteins, and methylation patterns. Presenters noted the importance of matching the right analyte with the right cancer, similar to personalized medicine’s goal of getting the right drug to the right patient, as not every cancer will be associated with the same blood-based biomarkers. For example, ctDNA is shed more in pancreatic cancer than prostate cancer.
The Push to Improve Early Lung Cancer Detection
Several companies are developing SCED tests for lung cancer detection, with many industry and clinician attendees underscoring the need to improve early lung cancer detection, particularly given poor screening adherence in the eligible population. Over half of the lung cancer cases detected through LDCT-based screening are found at stage I, when it is most treatable, and lung cancer screening has been shown to reduce lung cancer mortality by over twenty percent. However, only about ten to twenty percent of eligible individuals utilize lung cancer screening.
Blood-based SCED tests for lung cancer may have the potential to “enhance the current screening paradigm” and improve early detection of lung cancer. Key to this potential is their adequate clinical validation, for which attendees highlighted several important considerations, including adequate representation across validation samples to ensure generalizability to the intended use population. The performance of lung cancer SCED tests must be assessed across lung cancer stages and histological subtypes, as well as demographic characteristics including race/ethnicity and age.
While some SCEDs are becoming available as laboratory-developed tests (LDTs), several companies are ultimately aiming for FDA authorization. Industry representatives noted, however, that this is not the final step. Further obstacles to widespread adoption of these tests beyond FDA approval include incorporation into clinical guidelines and reimbursement, key to which is evidence of clinical utility.
SCEDs versus MCEDs
In addition to SCED tests, diagnostic companies are also developing MCED tests to assess blood-based biomarkers across more than one cancer type. Participants noted the laudable goal of having a single test to detect multiple types of cancer, but also key challenges to MCED development and implementation. Developers noted the difficulty in appropriately dialing sensitivity and specificity of MCED tests compared to SCED tests. The high evidentiary bar needed to demonstrate clinical utility of MCED tests was also highlighted. Stakeholders noted practicality challenges with MCEDs, particularly the lack of clarity for clinicians on how to handle next steps for a patient with a positive MCED test result, and underscored the importance of facilitating rather than complicating clinical decision-making.
LUNGevity’s Perspective
LUNGevity remains a strong advocate for the robust validation of diagnostic tests, including lung cancer SCEDs and MCEDs becoming increasingly available in the clinic. We also advocate for the conduct of clinical utility studies to instill confidence that their use will facilitate clinical decision-making and improve patient outcomes. LUNGevity also strongly encourages clinicians to review test performance claims and the clinical validation study designs supporting those claims to guide the appropriate clinical use of these tests.