Why is the fact that this test requires no amplification so important?

Amplification (PCR) is required in most molecular assays because detection systems lack the sensitivity to measure the tiny quantities of DNA or RNA directly present in a sample. PCR makes millions of copies of the target molecule, creating enough material to measure. But this process introduces exponential variation — small differences in amplification efficiency get magnified into large measurement differences. The result is wide data spread, overlapping distributions for cancer and healthy populations, and the inability to set a clean threshold. Yenos's nanopore single-molecule counting achieves femtomolar sensitivity without amplification. Each molecule is measured exactly once, as-is, with no copying errors. The result is the tight, non-overlapping data distributions that enable zero data overlap and a clean 1.5× HL threshold.