We saw a problem and said we can do better.

Approximately 4,000,000 births occur in this country each year. According to the Center for Disease Control (CDC), the preterm birth rate in the U.S. was 9.8% in 2016, or about 1 in 10 pregnancies — one of the highest rates in the developed world — resulting in approximately 400,000 premature births each year.

At Sera Prognostics we recognize the continuously rising pre term birth costs and health care cost, not to mention the emotional and financial burden it puts on families, and the immediate and life-long health challenges premature babies face.

We assembled a team of extremely qualified experts to find a solution for the problem of prematurity that could help address this major public health challenge.

The result is the PreTRM® test — the first and only broadly clinically-validated blood test that provides an early and individualized prediction of preterm birth risk. This knowledge gives the mother and her doctor the ability to manage her risk with the goal of giving her baby the best start in life. 

The PreTRM test also enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health.

The following interview with Dr. Jay Boniface, the Chief Scientific Officer of Sera Prognostics, developer of the PreTRM test, explains the Science behind the test.

Interviewer: Dr. Boniface, how was the PreTRM test developed?

Dr. Boniface: We began development of the PreTRM test looking at hundreds of proteins broadly across pregnancy.

Interviewer: Why proteins?

Dr. B.: Proteins carry out the most important functions in life. They’re the worker bees of cells and tissues and organisms and if there is a disturbance of some sort, a condition or a disease, proteins are impacted, so they’re the logical biomarker that one should look at.

Interviewer: Which proteins did you select for the PreTRM test?

Dr. B.: Sera discovered two very important proteins that are diagnostic of preterm birth. Those proteins are IBP4, which stands for insulin-like growth factor binding protein four, and SHBG, which stands for sex hormone binding globulin.

Interviewer: Why protein IBP4?

Dr. B:  IBP4 is a regulator of growth factor pathways, namely insulin-like growth factors, or IGF's. IGF's are profoundly important for the development and growth of both the fetus and the placenta. IBP4 sits at a crossroad where it regulates this growth response pathway. If there is anything wrong with placental or fetal development, IBP4 may be responding to that.

Interviewer: Why protein SHBG?

 Dr. B:  SHBG, or sex hormone binding globulin, regulates the levels of estrogens and androgens, or in other words sex steroid hormones. Estrogens tend to drive pregnancy towards labor, or in other words they oppose the action of progesterone, which is known to maintain pregnancy. Sera sees SHBG levels decreased in women destined to give birth prematurely. Low levels of SHBG would correspond to higher levels of estrogen, which would drive the pregnancy toward labor and explain pre-term birth

Interviewer:  How does the test work?

Dr. B: Sera takes the measures of these two proteins, IBP4 and SHBG, and combines these results in a proprietary, mathematical algorithm or predictor. The score that we derive for each individual patient corresponds to an individual risk of preterm birth, for that patient.

Interviewer: What is the benefit of the PreTRM test?

Dr. B.: The benefit of the PreTRM test is that, until now it was not possible for a woman to know her individual risk of delivering her baby prematurely. With the availability of our test, a pregnant woman and her doctor can be given this information, and together they can better manage the pregnancy.

NOTE:

The full scientific study supporting the PreTRM test was published in the June 2017 issue of Clinical Mass Spectrometry. The study details the strong science and rigorous analytical process discipline behind the PreTRM test. 

“It further demonstrates the robustness of our LC/MS technology platform,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics, developer of the PreTRM test. 

The test’s validation was published as the Editors’ Choice lead article in the American Journal of Obstetrics & Gynecology. It can also be found in the May 2016 issue of AJOG.