What is the PreTRM® Test?
The PreTRM Test is the only broadly clinically validated test that provides an accurate, early, and individualized prediction of premature birth risk.
The PreTRM Test is administered as a single blood draw between 19wk/1d-20wk/6d (134-146 days) gestation.
PreTRM provides both your patient’s percentage of risk for delivering her baby prematurely with a validated threshold, and her risk of spontaneous premature birth relative to the population risk.
The PreTRM Test is appropriate for all singleton pregnancies in women aged 18 or older who are asymptomatic for preterm labor, not on progesterone therapy after the first trimester, and in which there are no confirmed genetic abnormalities and/or structural anomalies associated with shortened gestation.
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.
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.
Sera’s Customer Support Team will assist the patient with scheduling sample collection between 19wk/1d-20wk/6d (134-146 days) gestation. It is critical that the patient’s 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 directly at: (801) 990-6600.
Sera is actively engaging with private and government insurance programs to increase access for the PreTRM® Test. Some commercial health plans are paying for the PreTRM Test for eligible members. Sera will make every attempt to obtain payment for the PreTRM Test from your patient’s health plan. If a patient wants more information about their benefits eligibility, they can contact our Patient Access Team directly at: (800) 291-1046.
Sera offers financial assistance for eligible patients who qualify. Our financial assistance program offers reduced-cost testing for the PreTRM Test and is available to U.S. based, income qualified patients enrolled in eligible health plans. Uninsured or under-insured patients may also be eligible. Patients with health insurance through a government program (e.g. Medicaid, Medicare, Tricare, Veterans Affairs) are not eligible for the Financial Assistance Program.
If a patient will have difficulty paying out-of-pocket costs associated with the PreTRM Test, Sera Prognostics offer interest-free monthly payment plan options. If patients are interested in this option they should contact our Patient Access Team directly at: (800) 291-1046.
The American Medical Association (AMA) has assigned a new, dedicated Current Procedural Terminology (CPT®) 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.
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.
Yes. Our CLIA ID number is 46D2064326. A copy of our license can be viewed here.
Yes. Our CAP number is 8715460 and our AU-ID is 1685065. A copy of our license can be viewed here.
Yes. NYS Department of Health approved laboratory performing the PreTRM Test for all 50 US states. A copy of our license can be viewed here.
Question Not Answered?
Are you unable to find what you are looking for? We are here for you. Send us an email at Support@www.pretrm.com or call us at 801-990-6605. We will get back to you promptly.