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novel test to assess the risk of preterm birth
A major diagnostic challenge until now

1. Grobman et al. Am J Obstet Gynecol. 2004 Jul; 191(1): 235-40.

of patients presenting with signs and symptoms of threatened preterm labour may be admitted to the hospital.1

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1. Grobman et al. Am J Obstet Gynecol. 2004 Jul; 191(1): 235-40.
A major diagnostic challenge until now

Clinical evaluation alone, including the measurement of cervical length and dilatation, is not sufficiently predictive of imminent delivery among patients with signs of threatened preterm labour.

Similarly, currently available biomarker tests, such as that which is based on the detection of fetal fibronectin (fFN), have extremely poor positive predictive values for imminent delivery.2

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2. ACOG Committee on Practice Bulletins-Obstetrics. Obstet Gynecol 2012; 119: 1308-1316.
2. ACOG Committee on Practice Bulletins-Obstetrics. Obstet Gynecol 2012; 119: 1308-1316.

PAMG-1 detection by PartoSure is the single best predictor of imminent spontaneous delivery within 7 days compared to fFN and CL. 3Nikolova et al., 2015

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3. Nikolova et al. J Perinat Med. 2015 Jul; 43(4): 395-402.
3. Nikolova et al. J Perinat Med. 2015 Jul; 43(4): 395-402.
A superior test for assessing preterm birth risk

The PartoSure Test is a rapid, non-invasive strip test for the detection of placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labour.

PartoSure’s unique features include:
  • High Positive and Negative Predictive Value
  • May be used shortly after vaginal exam
  • Speculum examination optional
  • Results in 5 minutes or less
  • No special equipment or training needed
  • Wide gestational age range from 20 to 37 weeks
Prediction of spontaneous preterm delivery within 7 days in patients with threatened preterm labour 3
chart

PPV
NPV
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Decreased costs by potentially reducing unnecessary interventions

4. Alfirevic et al. Ultrasound Obstet Gynecol. 2007; 29: 47-50
5. Van Baaren et al. Am J Obstet Gynecol 2013; 209: 436.e1-8.

of patients admitted to the hospital for threatened preterm labour (PTL) do not deliver within the next 7 days.4
Average charges for threatened preterm labor management can cost up to $20.3K.5

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4. Alfirevic et al. Ultrasound Obstet Gynecol. 2007; 29: 47-50
5. Lucovnik et al., Am J Obstet Gynecol. 2013 Sep;209(3):217.e1-3.

Decreased costs by potentially reducing unnecessary
interventions
The high accuracy of the PartoSure test may therefore contribute to reducing costs by:
  • Reducing the length of stay of high risk patients
  • Decreasing unnecessary admissions and acute interventions
  • Minimizing unnecessary patient transfers
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Improved confidence when
cervical length is equivocal

The PartoSure test is most useful in cases where cervical length is between 15 and 30 mm where the predictive value of cervical length is lowest. While a cervical length-cutoff of 25 mm is often utilized, up to 1 in 8 women with a cervical length between 25-30 mm will deliver within the next 7 days.6

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6. Nikolova et al. J Perinat Med. 2014 Jul; 42(4): 473-7.
6. Nikolova et al. J Perinat Med. 2014 Jul; 42(4): 473-7.

Consistent performance across studies and geographies

 

Comparing PAMG-1 to Fetal Fibronectin7

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 Women
7. Heverhagen et al. J. Perinat. Med.  2015; 43(S1): 240.

The novel bedside PAMG-1 test has a higher positive predictive value compared to other commercially available bedside tests for preterm birth such as fetal fibronectin or IGFBP-1. 8

-Heverhagen et al., 2015
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7. Heverhagen et al. J. Perinat. Med.  2015; 43(S1): 240.
Improved confidence when assessing risk of preterm delivery in symptomatic women

The PartoSure Test is intended to be used as an aid to rapidly assess the risk of preterm delivery in ≤7 or ≤14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labour, intact amniotic membranes and minimal cervical dilatation (≤3 cm), sampled between 20 weeks, 0 days and 36 weeks, 6 days gestation.

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September 26, 2017

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Parsagen Diagnostics, Inc
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Tel: +1 (857) 816-3361