Neopath is conducting clinical trials in the United States for a primary screening indication. PapNet is approved to detect abnormal cells that are not detected in manual screening as a supplementary test in addition to manual inspection, explains NSI president and CEO Mark Rutenberg. It is no more a QC of manual screening than a mammogram is a QC of a breast examination. There is good evidence that false negative smears of clinical significance are due to a small number of high-grade cells on a slide that are not detectable manually. PapNet was designed to detect those cases.
Patients are willing to pay and labs have quite high collection rates.