Intraamniotic infection is one of the most common causes of preterm labor, occurring in 17%- 34% of all cases of preterm labor.¹⁶ IAI is responsible for a disproportionate share of aggregate prenatal healthcare costs (estimated in the United States to be $4 to $6 billion annually).²¹

Untreated IAI is associated with significant clinical complications and associated health care costs. As indicated in the table below, untreated IAI is associated with 2.7 - 3.4 times higher likelihood of serious complications such as neonatal sepsis, respiratory distress syndrome and periventricular leukomalacia / cerebral palsy, as compared to when IAI is not present.



The cost to the healthcare system associated with the complications of IAI are also significant: the average hospital costs per case of neonatal sepsis is $63,000²² and the average lifetime cost of cerebral palsy is estimated at over $500,000.¹⁷

When IAI is diagnosed and treated, it’s clinical consequences/and related healthcare costs can be significantly reduced. For example the incidence of neonatal sepsis associated with IAI is reduced by 4 times from 9.3% to 2.1%, when IAI is treated with antibiotics prior to delivery.¹⁸

The challenge today is that IAI is difficult to diagnose because 80 — 90% of cases have no clinical signs or symptoms and definitive diagnosis requires amniocentesis and laboratory testing of amniotic fluid.¹⁹ Amniocentesis is an invasive procedure and currently available laboratory tests to detect IAI in amniotic fluid have limitations. Due to the limitations of currently available diagnostic tests for IAI, a significant percentage of cases remain undiagnosed and untreated.

The graphic below indicates, of the estimated ~ 195,000 cases of IAI in the US per year, amniocentesis is performed to allow potential diagnosis of IAI in ~50% of cases.²⁰ Correspondingly, the remaining 50% of cases can remain undiagnosed and untreated.



A comprehensive and sophisticated pharmacoeconomic model has been developed in conjunction with leading clinical experts and health economists that rigorously quantifies the clinical outcomes and related hospital costs resulting from the current standard of care for the diagnosis and treatment of intraamniotic infection in preterm labor.

Modeling results show for every 1,000 preterm labor patients managed according to the current standard of care, 169 IAI cases go undetected and therefore are untreated. This under diagnosis and under treatment of IAI results in 107 cases of neonatal sepsis, 48 neonatal deaths and 175 mothers who receive suboptimal treatment.

Total hospital costs of treating the clinical outcomes associated with the current diagnosis and treatment paradigm for IAI in preterm labor are $25,170,238. In addition, there are incremental, long-term health care costs associated with the clinical sequelae of IAI, such as cerebral palsy, beyond the ~$25,000,000 hospital costs described above.

ProteoGenix’ new, diagnostic tests for IAI overcome critical limitations of currently available diagnostic tools and therefore allow for more comprehensive and accurate diagnosis of IAI; therefore enabling treatment that significantly reduces the clinical complications and associated healthcare costs as compared to the current standard of care.