AmniSure® is the first FDA-cleared rapid immunoassay that detects Rupture Of [fetal] Membranes (ROM), a major cause of pregnancy complications. It is also the first test of its kind that received reimbursed status in the US (CPT 84112). AmniSure® is the only ROM test that does NOT require speculum examination and is ~99% accurate. AmniSure® International LLC works to establish AmniSure® test as a standard of care for ROM diagnosis worldwide.