u2795 How is the PreTRM Test administered?

The PreTRM Test is performed via a single blood draw between 18 and 20 6/7 weeks of gestation (126-146 days).

u2795 What does the PreTRM Test tell you?

PreTRM provides both your patientu2019s percentage of risk for delivering her baby prematurely with a validated threshold, and her risk of spontaneous premature birth relative to the population risk.

u2795 Who are candidates for the PreTRM Test?

The PreTRM Test is appropriate for all singleton pregnancies in women who are asymptomatic for preterm labor.u00b9

u2795 How do I order the PreTRM Test?

The PreTRM Test must be ordered by a licensed healthcare provider. Orders can be placed online for a more efficient ordering process, faster report delivery, and enhanced patient support for sample collection. You can also use a paper test requisition form.

u2795 How will I get the PreTRM Test Report?

If you ordered through our online portal, the PreTRM Test Report will be available to view and download through the portal. You will also receive an email notifying you that the report is ready to be accessed online. If you ordered with a paper test requisition form, the PreTRM Test Report will be faxed to your practice.

u2795 How is the single blood sample collected after I order the PreTRM Test?

Serau2019s Customer Support Team will assist the patient with scheduling sample collection between 18 and 20 6/7 weeks of gestation (126-146 days). It is critical that the patientu2019s contact information be included with the test order. There is a broad network of phlebotomists that are equipped to perform the specimen collection and handling requirements for the PreTRM Test. Once the sample is collected and processed, the phlebotomist will ship it to Sera to run the PreTRM Test. If a patient needs assistance with sample collection, they can contact our Patient Support Team at: (801) 990-6605.

u2795 How much does the PreTRM Test cost?

Most patientsu2019 out-of-pocket cost for the PreTRM Test is less than $100*. We believe cost should not be a barrier to information that can help you deliver a healthy baby. With or without insurance, our Customer Support Team is ready to help. We have financial support options to help those with higher than expected out-of-pocket cost including a patient assistance program, prompt pay discount, or interest-free monthly payment plan options. Your patient may receive an explanation of benefits (EOB) from their insurance company. This is not a bill. We will work with their insurance company to manage the appeals process. *The amount you pay for PreTRM can depend on a number of factors, including the type of insurance you have, and even the level of coverage your insurance may provide. Call: (801) 990-6605; Email: billing@pretrmaccess.com

u2795 What is the CPT PLA code for the PreTRM Test?

The American Medical Association (AMA) has assigned a new, dedicated Current Procedural Terminology (CPTu00ae) Proprietary Laboratory Analysis (PLA) code, 0247U, to facilitate Sera billing and payment for the PreTRM Test. This code is included in the revised set of PLA codes the AMA released on December 30, 2020, with an effective date of April 1, 2021.

u2795 What testing methodology is used to run the PreTRM Test?

The PreTRM test identifies biomarkers in maternal serum that have been clinically validated to be predictive of spontaneous preterm birth. Serum samples are analyzed via chromatographic separation followed by Multiple Reaction Monitoring (MRM) multiplex mass spectrometry. An algorithm combines the resulting biomarker relative abundances with individual clinical parameters to calculate the individualized patient risk prediction for spontaneous preterm birth.

u2795 Is Sera Clinical Laboratory Improvement Amendments (CLIA) certified?

Yes. Our CLIA ID number is 46D2064326.

u2795 Is Sera College of American Pathologists (CAP) accredited?

Yes. Our CAP number is 8715460 and our AU-ID is 1685065.

u2795 Is Sera approved in all 50 U.S. states?

Yes. NYS Department of Health approved laboratory performing the PreTRM Test for all 50 US states.

Most spontaneous preterm births occur in patients with no known risk factors.³ The PreTRM Test helps providers identify that risk early, allowing for proactive care.

Question not answered?

Are you unable to find what you are looking for? We are here for you. Send us an email at Support@pretrm.com or call us at 801-990-6600. We will get back to you promptly.

References

Considerations for use: The PreTRM Test for Risk Management predicts the risk of spontaneous preterm birth (before 37 weeks) in asymptomatic women (no signs or symptoms of preterm labor with intact membranes) ≥18 years old with a singleton pregnancy. The PreTRM Test is performed via a single blood draw between 18wk – 20wk/6d (126 – 146 days) gestation. It is not intended for use in women who have a multiple pregnancy, have a known or suspected fetal anomaly, or are on any form of progesterone therapy after the first trimester. If the PreTRM Test was ordered for a patient outside of intended use for this test, caution should be exercised when interpreting the personalized risk results.
Hoffman MK, Kitto C, Zhang Z, Shi J, Walker MG, Shahbaba B, Ruhstaller K. Neonatal Outcomes after Maternal Biomarker-Guided Preterm Birth Intervention: The AVERT PRETERM Trial. Diagnostics. 2024; 14(14):1462. https://doi.org/10.3390/diagnostics14141462
Iams, JD. Clinical Practice. Prevention of preterm parturition. N Engl J Med. 2014;370:254-61.

What is the PreTRM® Test?

Most spontaneous preterm births occur in patients with no known risk factors.3 The PreTRM Test helps providers identify that risk early, allowing for proactive care.

How is the PreTRM Test administered?

What information does the PreTRM Test provide?

Which patients are appropriate for the PreTRM Test?

How do I order the PreTRM Test?

How will I receive the PreTRM Test report?

How can PreTRM results inform patient care?

What is the cost of the PreTRM Test?

What is the CPT® PLA code for the PreTRM Test?

What testing methodology is used?

Is Sera CLIA certified?

Is Sera CAP accredited?

Is the PreTRM Test available in all 50 U.S. states?

Question not answered?

References

What is the PreTRM^® Test?

Most spontaneous preterm births occur in patients with no known risk factors.³ The PreTRM Test helps providers identify that risk early, allowing for proactive care.