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BYU-U. research key in premature birth prevention test

Preterm birth predictor inching closer to marketability

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Mari Cuthbert (not pictured) holds her son, Jaden, a premature baby, at a local hospital while talking about a BYU/University of Utah study that uses a blood test to predict preterm delivery.

Mari Cuthbert (not pictured) holds her son, Jaden, a premature baby, at a local hospital while talking about a BYU/University of Utah study that uses a blood test to predict preterm delivery.

Julie Walker, BYU

SALT LAKE CITY — A women's healthcare company has just completed a new round of funding to support commercialization of a blood test that could identify which pregnant women are at high risk of delivering their babies too soon.

Utah-based Sera Prognostics Inc. said Tuesday that it had closed a $19.3 million financing round to develop the test, which is based on a research collaboration between BYU and the University of Utah.

If all goes well, said Sera's new CEO and chairman, Dr. Gregory C. Critchfield, the study could be completed in late 2012, with availability of the test itself in 2013.

"It's hugely important for families," said Critchfield, who had retired as president of Myriad Genetics. He noted that the complications of preterm birth are sometimes life-altering, including respiratory, neurological, visual and other medical debilities. Sometimes, babies born prematurely don't survive; prematurity is the leading cause of infant death.

The goal of the preterm birth predictor is to identify women at risk of having their babies too early so care providers can intervene and positively impact the outcome. "Hopefully, those babies would be born at a state of more full development," he said.

March of Dimes said more than $26 billion is spent each year to manage the complications of preterm birth, defined as being born before 37 weeks' gestation.

As many as 13 percent of all pregnancies — about a half-million in the United States alone — end in early deliveries and 80-plus percent of preterm births are unanticipated. Being able to predict that and change outcomes would be of great interest and benefit to every woman who is pregnant or will be, said Steven Graves, Ph.D., a professor of chemistry and biochemistry at Brigham Young University, who oversaw the lab work that led to development of the test. He collaborated with Dr. Sean Esplin, obstetrician and associate professor of maternal-fetal medicine at the U., who oversaw the clinical side.

The U. and BYU hold patents and have licensed the testing to Sera Prognostics. The preterm birth test includes examining three proprietary peptides and six different proteins that indicate increased risk of preterm birth.

When physicians know a woman is at risk of delivering early, "there are therapeutic options for the doctor to help prolong the pregnancy and prepare the infant for life outside the mother," said Graves, who noted that three-fourths of health problems in newborns are from prematurity. Even if preterm birth couldn't be prevented, doctors might be able to help the baby in utero so there would be fewer problems. But routine efforts to determine who might be at risk are thwarted because a woman who delivers preterm once may not again. And someone who has always delivered full-term babies in the past may deliver early, Graves said.

"With preterm birth, if we could even prolong a pregnancy by one or two weeks, we could make a very big impact on the number of babies that survive and make sure that those that survive are healthy," said Esplin last year when the BYU-Utah collaboration had a study published in the American Journal of Obstetrics and Gynecology. "With just one intervention, we could have a really huge impact," he said.

In that study, the test showed sensitivity of 86.5 percent and specificity of 80.6 percent for preterm birth at 28 weeks of pregnancy. At the Society for Maternal-Fetal Medicine meeting in February, the test predicted preterm birth at 24 and 28 weeks gestation with 94 percent sensitivity and 85 percent specificity, Sera told ProteoMonitor.

"The test is predictive," said Graves, who noted that the early studies found an ability to identify women four to five weeks before there was any indication something was wrong with the pregnancy — and sometimes even earlier. He called it promising, but not yet verified, which is why there's need for the ongoing multicenter studies before it can be marketed. In the meantime, the Utah-BYU research partnership is conducting and planning other studies related to pregnancy complications, he said.

The funding round was led by venture capital firms InterWest Partners, Domain Associates, and Catalyst Health Ventures. It included Osage University Partners and Sera founder UpStart Life Sciences Capital.

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