For the First Time in Israel: New Blood Test Assesses Preterm Birth Risk Mid-Pregnancy

One of the greatest challenges in obstetric medicine is that a significant portion of preterm births occurs in women whose pregnancy appears completely normal. They do not suffer from contractions, pain, or warning signs, are not classified as being in a risk group, and continue their pregnancy routine until a preterm birth develops unexpectedly.

In Israel, one in every 15 babies is born premature, and preterm birth is considered a leading cause of morbidity and mortality in newborns. Beyond the medical significance, it often involves prolonged hospitalization in the NICU, complex treatments, and years of subsequent medical and developmental follow-up.

Now, a new blood test called preTRM is being introduced in Israel, providing doctors with an additional tool for the early identification of pregnancies at increased risk for preterm birth, even before symptoms appear. The test is intended for women with a single-fetus pregnancy and is performed between weeks 18 and 20 via a simple blood sample. It measures the ratio between two proteins and, combined with a dedicated algorithm, provides an individual risk assessment.

This is a risk assessment tool, not a diagnostic one. A result indicating an increased risk does not mean the woman will give birth early, but rather provides the physician with additional information to assist in decision-making regarding follow-up and treatment based on the clinical picture.

The test has been examined in several large-scale international studies. In the PRIME study, where women identified as having an increased risk underwent a course of treatment and adapted follow-up, a 53% reduction in births before week 32 was recorded, along with a 35% reduction in births before week 35 and a 22% reduction in the number of newborns requiring NICU hospitalization.

At this stage, the test is offered privately at the Ichilov Medical Center. Simultaneously, Sharafim Diagnostics, which holds the distribution rights in Israel, is promoting research collaborations with other medical centers and Clalit Health Services to examine its contribution within the local healthcare system.

Dr. Asaf Gertler, CEO of Sharafim Diagnostics, states:

"Beyond the medical innovation, the dramatic significance of this test is a conceptual change. For years, obstetric medicine focused on identifying women who were already in a risk group or those who developed clinical signs. Today, for the first time, we can receive a biological indication at an early stage, even in women whose pregnancy looks completely normal, and provide them with more accurate treatment and follow-up. Beyond the medical aspect, early detection has dramatic economic implications, as prematurity is one of the most expensive areas for public health. If we manage to reduce even a small part of the severe cases, it represents a potential saving of hundreds of millions of shekels a year, alongside a real improvement in the quality of life for families."

Prof. Simcha Yagel, a leading expert in maternal-fetal medicine in Israel and former director of the Department of Obstetrics and Gynecology at Hadassah Medical Center, who advises the company, adds:

"The earlier pregnancies at increased risk can be identified, the better the method of monitoring and managing the pregnancy can be adapted. It is important to emphasize that this is a tool for risk assessment that integrates into the set of clinical considerations, not a substitute for a medical decision."