Key Proteo

Key Proteo is a Seattle-based proteomics diagnostics company focused on the early detection of rare but treatable genetic disorders through its Immuno-SRM technology. The company has submitted a de novo classification request to the FDA for its Newborn Screening Kit designed to detect Wilson Disease, Wiskott-Aldrich Syndrome, X-linked Agammaglobulinemia, and Adenosine Deaminase Deficiency—four disorders not typically screened for in current newborn screening programs. The technology enables highly accurate, scalable, and cost-effective detection of previously undetectable disorders using dried blood spot or buccal swab samples, potentially enabling timely intervention to avoid irreversible outcomes in newborns[1][5][8]. A recent pilot study screened over 22,000 newborns, and a clinical study analyzed 4,690 newborn samples across three North American sites[5][8]. The kit is currently available for research use only.