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Novel test to predict the risk of preterm birth

Recently recognized by
the European Guidelines
Journal

Journal

September 26, 2017

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

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

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

Nikolova et al., 2015

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A superior test for
assessing preterm birth risk

PPV
NPV

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
An average admission
during which the
patient is treated can
cost up to 8000 €.4
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
Decreased costs by potentially reducing
unnecessary interventions
%

of patients admitted to the hospital for threatened preterm
labour (PTL) do not deliver within the next 7 days.5

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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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PPV
NPV

See Studies  
 
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.

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. 7

-Heverhagen et al., 2015

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  1. Grobman et al. Am J Obstet Gynecol. 2004 Jul; 191(1): 235-40.
  2. ACOG Committee on Practice Bulletins-Obstetrics. Obstet Gynecol 2012; 119: 1308-1316.
  3. Nikolova et al. J Perinat Med. 2015 Jul; 43(4): 395-402.
  4. Van Baaren et al. Am J Obstet Gynecol 2013; 209: 436.e1-8.
  5. Alfirevic et al. Ultrasound Obstet Gynecol. 2007; 29: 47-50
  6. Nikolova et al. J Perinat Med. 2014 Jul; 42(4): 473-7.
  7. Heverhagen et al. J. Perinat. Med.  2015; 43(S1): 240.
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© 2017 PartoSure Test. © 2017 Parsagen Diagnostics, Inc. The PartoSure Test is CE marked and is currently investigational use only in the United States.

Parsagen Diagnostics GmbH
Louise-Dumont-Str. 25
D-40211 Dusseldorf
Tel: +49 (211) 54 22 49 49
info@partosure.com

Parsagen Diagnostics, Inc
Harvard Innovation Launch Lab
114 Western Avenue,
Boston, MA 02134 USA
Tel: +1 (857) 816-3361