Beyond intended use: PSA, hCG as tumor markers
June 2025—At Corewell Health William Beaumont University Hospital in Royal Oak, Mich., the PSA test volume for men ages 40 to 49 is significant—about 150 samples per month, or 10 percent of the laboratory’s total PSA testing volume. But with no PSA assay approved for men under age 50, the laboratory set out to validate its Abbott Architect assay for this age group as a laboratory-developed test. Qian (Katie) Sun, PhD, D(ABCC), technical director of automated chemistry and urinalysis, explained how it was done in an ADLM session last year on designing validation protocols for off-label use of tumor markers in diverse patient populations. She also spoke about the use of hCG immunoassays as a tumor marker in gestational trophoblastic disease and select germ cell tumors.