¹ Gonçalves LF, Chaiworapongsa T, Romero R. Intrauterine infection and prematurity. Ment Retard Dev Disabil Res Rev. 2002;8(1):3-13; Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm birth. N Engl J Med. 2000 May 18;342(20):1500-7

² Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm delivery. N Engl J Med. 2000;342(20):1500-1507.; Romero R, Sirtori M, Oyarzun E, et al. Infection and labor. V. Prevalence, microbiology, and clinical significance of intraamniotic infection in women with preterm labor and intact membranes. Am J Obstet Gynecol. 1989;161(3):817-824.

³ Hitti J, Tarczy-Hornoch P, Murphy J, Hillier SL, Aura J, Eschenbach DA. Amniotic fluid infection, cytokines, and adverse outcome among infants at 34 weeks’ gestation or less. Obstet Gynecol. 2001;98(6):1080-1088. ;Yoon BH, Romero R, Moon JB, et al. Clinical significance of intraamniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001;185(5):1130-1136. ;Jacobsson B, Mattsby- Baltzer I, Andersch B, et al. Microbial invasion and cytokine response in amniotic fluid in a Swedish population of women in preterm labor. Acta Obstet Gynecol Scand. 2003;82(2):120-128. ;Figueroa R, Garry D, Elimian A, Patel K, Sehgal PB, Tejani N. Evaluation of amniotic fluid cytokines in preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2005;18(4):241-247. ;Gomez R, Romero R, Nien JK, et al. A short cervix in women with preterm labor and intact membranes: a risk factor for microbial invasion of the amniotic cavity. Am J Obstet Gynecol. 2005;192(3):678-689. ; Buhimschi IA, Zhao G, Pettker CM, et al. The receptor for advanced glycation end products (RAGE) system in women with intraamniotic infection and inflammation. Am J Obstet Gynecol. 2007;196(2):181.e1-181.e13.

⁴ DiGiulio DB, Romero R, Amogan HP, et al. Microbial prevalence, diversity and abundance in amniotic fluid during preterm labor: a molecular and culture-based investigation. PLoS One. 2008;3(8):e3056. ; Han YW, Shen T, Chung P, Buhimschi IA, Buhimschi CS. Uncultivated bacteria as etiologic agents of intraamniotic inflammation leading to preterm birth. J Clin Microbiol. 2009;47(1):38-47. ; Markenson GR, Martin RK, Tillotson-Criss M, Foley KS, Stewart RS Jr, Yancey M. The use of the polymerase chain reaction to detect bacteria in amniotic fluid in pregnancies complicated by preterm labor. Am J Obstet Gynecol. 1997;177(6):1471-1477.

⁵ Alexander JM, Gilstrap LC, Cox SM, McIntire DM, Leveno KJ. Clinical chorioamnionitis and the prognosis for very low birth weight infants. Obstet Gynecol. 1998;91(5 Pt 1):725-729.

⁶ Gravett MG, Thomas A, Schneider KA, et al. Proteomic analysis of cervical-vaginal fluid: identification of novel biomarkers for detection of intraamniotic infection. J Proteome Res. 2007;6(1):89-96.

⁷ Gravett MG, Thomas A, Schneider KA, et al. Proteomic analysis of cervical-vaginal fluid: identification of novel biomarkers for detection of intraamniotic infection. J Proteome Res. 2007;6(1):89-96.

⁸ Wu YW, Colford JM Jr. Chorioamnionitis as a risk factor for cerebral palsy: A meta-analysis. JAMA. 2000;284(11):1417-1424.

⁹ Gravett MG, Novy MJ, Rosenfeld RG, et al. Diagnosis of intraamniotic infection by proteomic profiling and identification of novel biomarkers. JAMA . 2004;292(4):462-469.

¹⁰ Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm delivery. N Engl J Med. 2000;342(20):1500-1507. ; Romero R, Sirtori M, Oyarzun E, et al. Infection and labor. V. Prevalence, microbiology, and clinical significance of intraamniotic infection in women with preterm labor and intact membranes. Am J Obstet Gynecol. 1989;161(3):817-824.

¹¹ Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm delivery. N Engl J Med. 2000;342(20):1500-1507.

¹² Han YW, Shen T, Chung P, Buhimschi IA, Buhimschi CS. Uncultivated bacteria as etiologic agents of intraamniotic inflammation leading to preterm birth. J Clin Microbiol. 2009;47(1):38-47.

¹³ DiGiulio DB, Romero R, Amogan HP, et al. Microbial prevalence, diversity and abundance in amniotic fluid during preterm labor: a molecular and culture-based investigation. PLoS One. 2008;3(8):e3056.; Han YW, Shen T, Chung P, Buhimschi IA, Buhimschi CS. Uncultivated bacteria as etiologic agents of intraamniotic inflammation leading to preterm birth. J Clin Microbiol. 2009;47(1):38-47.; Markenson GR, Martin RK, Tillotson-Criss M, Foley KS, Stewart RS Jr, Yancey M. The use of the polymerase chain reaction to detect bacteria in amniotic fluid in pregnancies complicated by preterm labor. Am J Obstet Gynecol. 1997;177(6):1471-1477.

¹⁴ Miralles R, Hodge R, McParland PC, et al. Relationship between antenatal inflammation and antenatal infection identified by detection of microbial genes by polymerase chain reaction. Pediatr Res. 2005;57(4):570-577.

¹⁵ Hitti J, Riley DE, Krohn MA, et al. Broad-spectrum bacterial rDNA polymerase chain reaction assay for detecting amniotic fluid infection among women in premature labor. Clin Infect Dis. 1997;24(6):1228-1232.

¹⁶ #2-7 from IAI Disease Awareness Brochure: Figueroa R, Garry D, Elimian A, Patel K, Sehgal PB, Tejani N. Evaluation of amniotic fluid cytokines in preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2005;18(4):241-247. (references: Yoon BH, Romero R, Moon JB, et al. Clinical significance of intraamniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001;185(5):1130-1136. Jacobsson B, Mattsby- Baltzer I, Andersch B, et al. Microbial invasion and cytokine response in amniotic fluid in a Swedish population of women in preterm labor. Acta Obstet Gynecol Scand. 2003;82(2):120-128. ; Figueroa R, Garry D, Elimian A, Patel K, Sehgal PB, Tejani N. Evaluation of amniotic fluid cytokines in preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2005;18(4):241-247. ; Gomez R, Romero R, Nien JK, et al. A short cervix in women with preterm labor and intact membranes: a risk factor for microbial invasion of the amniotic cavity. Am J Obstet Gynecol. 2005;192(3):678-689. ; Buhimschi IA, Zhao G, Pettker CM, et al. The receptor for advanced glycation end products (RAGE) system in women with intraamniotic infection and inflammation. Am J Obstet Gynecol. 2007;196(2):181.e1-181.e13.

¹⁷ Waitzman NJ, Romano PS, Scheffler RM. Estimates of the economic costs of birth defects. Inquire 1994; 31:188-203.

¹⁸ IAI disease Awareness brochure: 14. Gilstrap LC 3rd, Bawdon RE, Burris J. Antibiotic concentration in maternal blood, cord blood, and placental membranes in chorioamnionitis. Obstet Gynecol. 1988;72(1):124-125. 15. Sperling RS, Ramamurthy RS, Gibbs RS. A comparison of intrapartum versus immediate postpartum treatment of intraamniotic infection. Obstet Gynecol. 1987;70(6):861-865. 16. Gibbs RS, Dinsmoor MJ, Newton ER, Ramamurthy RS. A randomized trial of intrapartum versus immediate postpartum treatment of women with intraamniotic infection. Obstet Gynecol. 1988;72(6):823-828

¹⁹ IAI disease Awareness brochure:: 1. Goldenberg RL, Hauth JC, Andrews WW. Intrauterine infection and preterm delivery. N Engl J Med. 2000;342(20):1500-1507. 3Hitti J, Tarczy-Hornoch P, Murphy J, Hillier SL, Aura J, Eschenbach DA. Amniotic fluid infection, cytokines, and adverse outcome among infants at 34 weeks’ gestation or less. Obstet Gynecol. 2001;98(6):1080-1088.

²⁰ Primary market research: 98 OB/GYN's, May 2008, 79 Maternal Fetal Medicine specialists, April 2009, 98 Maternal Fetal Medicine specialists February 2008. Data on file with ProteoGenix.

²¹ Gravett MG, Novy MJ, Rosenfeld RG, et al. Diagnosis of intraamniotic infection by proteomic profiling and identification of novel biomarkers. JAMA . 2004;292(4):462-469.

²² Alexander, 1998.

²³ Reference number 13 and 14 from IAI disease awareness brochure.

²⁴ References from IAI disease awareness brochure # 14, 15 and 16.

²⁵ Ogunyemi , Eur J Obstet Gynecol Reprod Biol. 2007.

²⁶ #1) Kenyon, “Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomized trial”, Lancet 2001. #2) Kenyon, “Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial ORACLE II trial. Lancet 2008.