Clinical Chemistry

June 2025—Patients who present to the ED with an elevated cardiac troponin above the 99th percentile and suspected acute coronary syndrome but in whom myocardial infarction is not diagnosed are at risk for future cardiac events. But how much risk? Last fall, the Food and Drug Administration cleared Siemens Healthineers’ Atellica IM High-Sensitivity Troponin I assay for prognostic risk stratification, an expanded intended use claim. Now, with this newly cleared use, “novel information is created from traditional indications,” said Christopher deFilippi, MD, who was recently director of the Biocore research laboratory and vice chair of academic affairs, Inova Schar Heart and Vascular in Fairfax, Va., and is now, since June 1, at the University of Maryland.

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.