Sera Prognostics this week said it raised $1.4 million in a Series A-1 financing round that it will use to fund efforts to develop a protein-biomarker-based blood test for predicting preterm births.
In a study published in the November issue of the American Journal of Obstetrics and Gynecology, the company's test demonstrated sensitivity of 86.5 percent and specificity of 80.6 percent for preterm birth at 28 weeks of pregnancy. Furthermore, two other blinded, case-controlled studies achieved sensitivities of 90 percent and 94 percent and specificity of 85 percent, Kenneth Chahine, president and chief operating officer, told ProteoMonitor.
There are approximately 525,000 preterm births in the US each year. According to the March of Dimes, the annual public healthcare cost of caring for preterm infants is more than $26 billion. Currently there are no tests on the market for predicting whether an asymptomatic woman will go on to have an early delivery.
Such a test would primarily be useful as a way for doctors to single out women in need of increased monitoring, Chahine said. Additionally, it could be used to determine which women should be prescribed progesterone, which is commonly given to increase gestation periods. Current guidelines from the American Congress of Obstetricians and Gynecologists recommend progesterone treatment for all women who've previously had a preterm birth. Only one-third of these woman, however, go on to have another early delivery.
The biomarker panel is based on intellectual property that Sera has licensed from the University of Utah and Brigham Young University. According to Chahine, the company is "transitioning into the commercial phase" by still doing some of the work on the test in academic labs, "but increasingly doing more work independently through a contract [research] organization" that is aiding in the development of immunoassays to be used in the test.
The current panel consists of five previously identified proteins plus three proprietary peptides. It is a multiplatform test with immunoassays used to measure the five proteins and mass spec used for the proprietary peptides. The company is creating antibodies for the peptides in hopes of transitioning to an all-immunoassay test, but, Chahine said, the first-generation version of the diagnostic "could be offered commercially as a combination mass spec-immunoassay."
Sera plans to offer the test first as a CLIA diagnostic – hopefully by the end of the year or early 2012 – and then later to submit it for approval with the US Food and Drug Administration, he said. The company intends it to be useful as a screening test for the general population, but expects that its use will initially be concentrated in high-risk populations, he added.
"The trials are being conducted with a patient population that would support a general screening test, but more likely than not it will be adopted sequentially first by the maternal fetal medicine specialists, then by OB-GYNs, and eventually creep its way into the general population," he said.
Sera is also investigating peptides it has identified that appear to be predictive of preeclampsia, Chahine said, although that work is "really at an early stage right now and not ready for prime time until it's been confirmed more scientifically."
The company is also looking for funding in addition to the $1.4 million announced this week and hopes to hold another round in the first half of this year, he said.
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