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With Validation Data Published, Reimbursement the Next Hurdle for Sera's PreTRM Test

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NEW YORK (GenomeWeb) – With the publication this week of a validation study in the American Journal of Obstetrics & Gynecology, Sera Prognostics continues to move toward a wide launch of its PreTRM proteomic test for assessing women's risk of preterm delivery.

According to John Elliott, an OB-GYN and medical director at Valley Perinatal Services, in Phoenix, Arizona, the test is much needed addition to physicians' toolbox. However, he told GenomeWeb that while he was quite enthusiastic about its potential, the test would need to obtain coverage from insurers before it could make a significant impact in preventing and managing preterm deliveries.

The PreTRM test measuremes two proteins, insulin-like growth factors binding protein 4 (IBP4) and sex-hormone binding globulin (SHBG), to determine a patient's likelihood of preterm delivery. It is intended to be given at 19 weeks gestation and provides women and their doctors with their percent risk of giving preterm birth along with a comparison of their individual risk to that of the general population.

In the validation study published this week, the test was able to predict whether a woman would deliver before 37 weeks with 75 percent sensitivity and 74 percent specificity, and an area under the receiver operating curve of .75. It was able to predict delivery before 35 weeks with 100 percent sensitivity and 83 percent specificity and an AUC of .93.

"From a medical preventative perspective, this is a huge innovation," Elliot told GenomeWeb, noting that while doctors use certain criteria such as smoking status and obesity to identify women at high risk of preterm delivery, these are imperfect. Additionally, he noted, "there is certainly no test that can give us a risk on a first-time pregnant mom who is not a smoker, not obese, and doesn't have any other potential risk factors."

Elliot, who was an unpaid clinical advisor to Sera during the development of the test, was also part of an early-access program launched by Sera last year. Through that program he was given five tests to be billed to patients at price of no more than $100 per test (the test's regular list price is $945) and potentially less depending on whether or not their insurance decided to cover its use.

He said that he has used all five, selecting for its use patients he considered at elevated risk. All five patients were identified by the test as being at low risk for preterm delivery and all are currently still pregnant and have received no interventions, he said.

Elliot said that were the test covered by insurance he would use it as a general screening tool for all pregnant women in his practice. However, he said, at its current price it is too expensive for him to recommend to his patients.

"It's an incredibly important diagnostic test," he said. "Why I can't do what I would love to do, which is screen every patient that comes into my office, is the fact that it is not covered by insurance."

Key to convincing payors, he said, would be demonstrating not only that the test is able to identify women at high risk of preterm delivery, but also that doctors can then treat those women in a way that will improve outcomes and lower costs. He noted that among some in the field there is a sense of fatalism surrounding preterm delivery, in that the options for improving outcomes are somewhat limited, largely revolving around progesterone treatment.

He said he believed, though, that " if you can identify a problem you can find ways to modify that problem."

Sera Chairman and CEO Gregory Critchfield noted that a number of insurers have in place high intensity care management programs for high-risk women, which indicates that they see a value in identifying and managing such patients.

"Outcome studies, which measure impact on health and economics, are currently being designed, and we look forward to generating health economic data," he told GenomeWeb, adding that the company is currently "in discussion with a number of payors to establish coverage."

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