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preterm birth

PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients and is already being used in 35 countries in Europe, the Middle East, Asia, and Latin America.

Recently-funded research aims to develop a rapid test that combines immunoassay and miRNA detection with magnetic nanosensors.

They acknowledge that while the technical hurdles of proteomic test development have become manageable, commercialization is still a major challenge.

The researchers said that better diagnostics are needed to distinguish between false preterm labor and true preterm labor to prevent unnecessary treatment.

The researchers are developing a clinical assay that would use multiple biomarkers to analyze low-abundance peptides indicative of preterm risk. 

The study details the validation of the mass spec-based preterm birth test, which the company launched nationwide last month through its agreement with LabCorp.

The agreement will allow Sera to leverage LabCorp's sales force and networks, but similar deals have failed to deliver for proteomics firms in the past.

Sera plans to make the test for preterm birth available nationwide this year with LabCorp as the exclusive US distributor.

A health-economic model of the company's preterm birth test found it could lower infant mortality by 23 percent and yield annual savings of around $500 million.

The partners will evaluate new biomarkers that they both find, and will assess the possibility for a preterm birth prognostic panel.

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