What is Trucheck?
Trucheck is a multi-cancer early detection (MCED) blood test that claims to detect multiple cancer types simultaneously, but it lacks peer-reviewed validation in average-risk screening populations and should not be used for cancer screening in asymptomatic adults without a recent cancer diagnosis.
Test Characteristics and Performance Claims
Trucheck is a blood-based multi-cancer early detection test developed by Datar Cancer Genetics that claims to detect cancer signals from multiple cancer types in a single blood sample 1.
In one case-control study, Trucheck reported a sensitivity of 90.0% and specificity of 96.4% for cancer detection 1.
However, this single study had a high overall risk of bias, primarily due to limited follow-up of participants with negative test results, and the study design (case-control) does not reflect real-world screening performance 1.
Critical Evidence Gaps and Lack of Validation
No randomized controlled trials have evaluated whether Trucheck or any other MCED test reduces cancer mortality or improves patient outcomes 1, 2, 3.
MCED tests like Trucheck have not been evaluated for safety and effectiveness in randomized controlled trials, and most insurance companies do not currently cover MCED testing 4.
None of the currently available MCED tests, including Trucheck, are approved by the FDA or endorsed by any clinical practice guideline or recommendation 4.
Potential Harms Without Proven Benefit
False-negative results from unvalidated multi-cancer blood tests can give patients false reassurance, delay diagnosis of symptomatic cancers, and lead to later-stage disease and increased mortality 5.
False-positive results may trigger unnecessary invasive diagnostic procedures and cause significant patient anxiety 5.
Critical gaps exist regarding the diagnostic workup to confirm cancer presence at any organ site, appropriate follow-up for positive results without definitive diagnosis, and potential harms such as overdiagnosis of indolent disease 3.
Expert Recommendations Against Use
Experts advise against prescribing or recommending multi-cancer blood tests that lack peer-reviewed validation in average-risk populations, due to insufficient evidence of benefit and safety 5.
Clinicians should not replace guideline-endorsed, evidence-based cancer screening modalities with unvalidated blood-based tests 5.
Promotion of multi-cancer blood tests without peer-reviewed evidence misleads clinicians and patients and creates clear potential for harm 5.
What Clinicians Should Do Instead
The American Cancer Society recommends a cancer-related check-up every three years for asymptomatic individuals between ages 20-39, and annually for asymptomatic men and women ages 40 and older 6.
Clinicians should offer and help patients complete age- and sex-appropriate guideline-recommended cancer screenings, such as mammography for breast cancer, colonoscopy or stool-based tests for colorectal cancer, and PSA testing with shared decision-making for prostate cancer 6, 4.
If patients inquire about MCED tests like Trucheck, clinicians should engage in shared decision-making discussions explaining the lack of evidence for benefit, potential for harm, and absence of FDA approval or guideline endorsement 4.
Common Pitfalls to Avoid
Do not confuse FDA clearance with evidence-based effectiveness—FDA clearance of a test does not equate to evidence-based effectiveness for cancer screening 5.
Do not allow patients to substitute unvalidated MCED tests for proven screening modalities, as this could result in missed opportunities for early detection of cancers with established screening benefits 5, 4.
Clinicians should not feel obligated to initiate discussions about MCED testing with their patients, but should be prepared to respond if patients ask 4.