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Key Proteo Submits De Novo Application for Newborn Screening Kit to FDA

NEW YORK – Proteomics firm Key Proteo announced Friday that it has submitted a de novo classification request to the US Food and Drug Administration for its newborn screening kit. 

The Key Proteo Newborn Screening Kit is a proteomics-based screening panel that helps identify four rare genetic disorders that current newborn screening programs do not typically test for: Wilson disease, Wiskott-Aldrich syndrome, X-linked agammaglobulinemia, and adenosine deaminase deficiency. 

The company's Immuno-SRM platform can perform targeted proteomic analysis of low abundance peptide biomarkers from a few drops of blood, the company said in a statement. The technology "expands the scope of detecting previously undetectable genetic disorders in newborns with high accuracy, effectiveness, and efficiency, and has demonstrated faster turnaround times and lower costs when compared to next-generation sequencing," it added. 

The Seattle-based company has screened more than 22,000 newborn samples in an ongoing pilot study in Washington and has completed a clinical study of 3,294 newborn samples at three sites across North America. The screening kit is currently available as a research-use-only test. 

The firm noted that nearly 100 genetic disorders have been identified that could potentially be adapted to its proteomics-based platform. 

In addition, Key Proteo said it is expanding its operations to include a CLIA-certified laboratory to address newborn screening needs among public health laboratories, reference laboratories, hospital laboratories, and other providers.