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Sera Prognostics, Anthem Partner on Preterm Delivery Risk Test to Improve Outcomes, Reduce Costs


NEW YORK — Sera Prognostics is collaborating with insurer Anthem and its subsidiary HealthCore on a study investigating Sera's PreTRM test for preterm birth risk as the company works to build evidence of its effectiveness that it hopes will drive insurer coverage.

The study's goal is to determine whether the PreTRM test can improve patient outcomes and reduce healthcare spending when used with various Anthem plans.

The partnership is part of Salt Lake City-based Sera's effort to line up payor coverage for the test before launching a serious commercialization effort. The company currently sells the assay as a laboratory-developed test run out of its CLIA laboratory but has to date invested relatively little in driving sales.

Called Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME), the study will help Sera generate "the kind of evidence that will be appealing to any payor," said Gregory Critchfield, the company's chairman and CEO. "If you're able to show health improvements and, as a result, show that there are economic savings as a result, all payors are interested in something like that."

The study, which began enrolling in November at 10 centers around the country, will follow roughly 5,600 women in Anthem health plans, including individual, employer, commercial, and Medicaid plans to investigate whether screening patients with the PreTRM test and treating patients identified as being high risk for preterm delivery with established interventions lowers costs and improves outcomes.

The PreTRM test measures the ratio of two proteins, insulin-like growth factor-binding protein 4/sex hormone-binding globulin (IBP4/SHBG), that are markers of placental dysfunction. In Sera's initial validation study, the Proteomic Assessment of Preterm Risk (PAPR) study, the test was able to identify women who gave birth at or before 35 weeks gestation with an area under the curve (AUC) of .93 and women who gave birth at or before 37 weeks with an AUC of .75.

In a more recent study, researchers found the test could identify women who gave birth prior to 32 weeks with an AUC of .71, which went up to .76 when body mass index was included as part of the score.

For Anthem, the PreTRM test offers the potential to address what is a major source of costs for health insurers. According to the March of Dimes, more than 1 in 10 babies in the US are born prematurely and annual health care costs to manage health issues due to prematurity are estimated to be more than $31 billion.

"Maternity itself is a big deal for us," said Marcus Wilson, president of HealthCore, noting that 1 out of every 9 babies born in the US is born under Anthem coverage.

"Preterm has always been something that is a concern, but the question has always been that while preterm is an issue, we haven't been able to do a lot about it," he said. "There are programs that we have that look at moms at risk using historical markers of risk, but the reality is that most preterm deliveries happen in moms where you don't know that they are at high risk."

Wilson said he first became aware of Sera when a friend of his in private equity who was considering an investment in the company asked him to take a look at it. This led to a review within Anthem and HealthCore of the test followed by work modeling its potential impact within the insurer's patient population.

These analyses led the company to believe the test could prove useful for reducing preterm birth among its members, Wilson said.

"Not only is this a big issue, it's something we might actually be able to do something about," he said. "If this works, and that is what this study is meant to prove out on a large scale, then we are going to be all in and we are going to figure out how we can get this used across out population in way that is really going to drive much better outcomes."

Wilson said that in the PRIME study, Anthem will be looking primarily for evidence that PreTRM results in a shift in the average length of gestation for women using the test. The study will also follow babies through hospital discharge and assess longer term outcomes and costs linked to preterm delivery at 180 days, one year, and three years of age.

Wilson said that one potential issue with the Sera test is that it must be administered within a fairly narrow window between 19 and 20 weeks into pregnancy.

"A lot of moms, especially in the Medicaid population, don't present to the healthcare system until after that time period," he said, adding that in addition to evaluating the test itself, Anthem was also look at what it actions it could take to make earlier contact with these women and their providers and to make them aware of what interventions they can take in cases where the Sera test indicates they are at elevated risk of preterm delivery.

He said that there are currently "good interventions" for women identified as being at risk of preterm delivery but not necessarily "great interventions."

In addition to Sera, companies like NX Prenatal and Nixxi are developing tests for assessing preterm delivery risk. Wilson said Anthem had evaluated other preterm risk assessment tools as part of the process of evaluating PreTRM but noted that most of the other entrants in the space were further from potential commercialization than the Sera test and that the insurer was not currently investigating any preterm tests aside from PreTRM. He said Anthem was also in discussions with Sera about other tests in its pipeline.

Critchfield said that the two parties aim to publish data from the study, which he noted will help Sera make the case for the PreTRM test not only with Anthem but also other insurers.

"We want people to look at the data and understand that there is a way to do things differently and better, and the studies are designed to answer the question how much better will it be," he said. "Having the results within [Anthem's] network will allow people to generalize those results widely."