HPV DNA testing replaces cytology in cervical screening (2000s)
For decades, cervical cancer screening relied on the Pap smear, a subjective microscope examination of cells. The FDA approved the first HPV DNA test for co-testing in 2003, and by 2014 an HPV test was approved as a primary screening option.
Clinics could triage women by infection status, cutting unnecessary procedures and repeat tests.
Molecular testing became the standard of care, showing that objective DNA-based tests can outperform subjective cytology in population screening.
GALEAS Bladder follows the same arc: an objective DNA test replacing a subjective, invasive procedure, with triage as the initial use case.
