|Sera Prognostics CEO Dr. Gregory Critchfield|
Prenatal screening tools are the trend du jour in the diagnostics industry, with companies such as Roche ($RHHBY), Sequenom ($SQNM) and Illumina ($ILMN) cashing in on the market with innovative DNA technology that screens for fetus abnormalities.
But Sera Prognostics is taking a different route, developing a product that identifies biomarkers early on during a pregnancy to predict a woman's risk of preterm birth. The Salt Lake City, UT-based company roped in $20 million in Series B funding earlier this month to further its PreTRM test, a diagnostic tool which uses a routine blood sample collected during the second trimester of pregnancy to screen for preterm birth. The company eventually plans to target its proteomic technology towards other conditions such as preeclampsia or high blood pressure.
"We're the only company in the space who has made a serious investment," Dr. Gregory Critchfield, Sera's chairman and CEO, told FierceDiagnostics. "No company is invested in collecting a U.S. population and doing the kind of discovery work that we're doing."
The hope is that eventually, the test could allow physicians to intervene earlier before complications arise. The public healthcare cost of caring for preterm infants in the U.S. has been estimated at $26 billion per year, Sera said on its website, and the company's PreTRM tool could save money while improving outcomes for the baby.
PreTRM also offers an advantage over current screening methods such as measuring cervical length or asking for a woman's medical history, as the test can identify women at risk for preterm birth as early as 17 weeks into pregnancy to help the baby remain in utero.
Sera recently completed enrollment for its Proteomic Assessment of Preterm Risk (PAPR) clinical study of the test that includes 5,500 patients from 11 U.S. clinical sites. Results are expected by the second quarter of 2015. Critchfield said that after the launch, the company hopes to sit down with regulators to discuss clinical intervention studies using PreTRM.
The company also plans to collect testing specimens in other countries besides the U.S. to expand its global reach. But for now, Sera's immediate work is completing validation for its test and making it available in the U.S., Critchfield told FierceDiagnostics.
"The whole area of functional proteomics is an area that is beginning to bear fruit, and we're going to see more of these kinds of tests in the future," Critchfield said. "Looking at the proteins gives you an idea of what's going on in the pregnancy that can't be measured with genetics. Our test is a novel way of looking at a problem and making predictions early on in a pregnancy in a way that hasn't been done before." -- Emily Wasserman (email | Twitter)