Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

The study population will include pregnant women who may be at risk for preterm delivery and
require the fFN test, as determined by their doctor to aid in patient management. The
subjects may or may not present with symptoms related to preterm labor and must satisfy the
device's approved labeling and the eligibility criteria.

For pregnant women with signs of labor, the Fetal Fibronectin (fFN) test is approved for use
as an aid to assess the risk of preterm delivery in ≤ 7 or ≤ 14 days from cervicovaginal
sample collection that have intact amniotic membranes and minimal cervical dilation (< 3 cm)
and are sampled between 24 weeks, 0 days and 34 weeks, 6 days. It is also approved for use
with additional clinical information in asymptomatic women with singleton pregnancies when a
sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6
days of gestation.

The fFN test is run on The Rapid fFN for the TLiIQ® System and a positive fFN result occurs
with concentrations ≥50ng/mL and a negative fFN test with concentrations <50ng/mL.

The current FDA-approved labeling for the collection of the fFN specimen requires a speculum
examination; however, the collection of the fFN specimen is often needed when the women
first arrives at the hospital labor and delivery unit, where nurses often are not trained or
credentialed to perform speculum examinations and a physician may not be readily available
to perform the collection. Therefore, there is an unmet need for a simpler collection
method.

The test article in this study is the collection of cervicovaginal samples for fFN
determination using a standardized collection method without a speculum. The control
article in this study is the collection of a cervicovaginal sample for fFN determination
using the approved collection method requiring a speculum examination. Both the test and
control fFN specimen samples will be collected and evaluated using the approved Rapid fFN
for the TLiIQ® System.

The primary objective of this study is to determine whether the proposed method of fFN
specimen collection without a speculum is substantially equivalent to the approved method
with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6
days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days
in asymptomatic women. A finding of substantial equivalency would support a modification to
the labeling to allow the collection of specimens for fFN determination with or without a
speculum examination.

Hypothesis: The method of fFN specimen collection without a speculum is not inferior to
collection with a speculum within a 5% margin of non-inferiority.