Why exactly is pregnancy a contraindication for OncuraKit?

Pregnancy causes profound, predictable alterations in circulating miRNA. The placenta is one of the most abundant sources of extracellular miRNAs in the body — it actively secretes large quantities of miRNAs (including miR-21) into maternal circulation throughout pregnancy. These pregnancy-specific miRNAs are measurable in maternal blood and urine from early in the first trimester and rise throughout pregnancy. Because OncuraKit's 1.5× HL threshold was calibrated on non-pregnant healthy individuals, the dramatically elevated miRNA levels present in normal pregnancy would likely push most pregnant women's results above the threshold, producing a false positive — a result indicating cancer risk when none exists. Using OncuraKit during pregnancy could cause unnecessary anxiety and lead to invasive diagnostic testing in a vulnerable population.