X-linked agammaglobulinemia

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

Retrieved on: 
Friday, March 29, 2024
Disease, WD, XLA, Infant, Patient, Classification, Mortality, Wiskott–Aldrich syndrome, RUO, IVD, Trial of the century, Proteomics, X-linked agammaglobulinemia, WAS, Hypogammaglobulinemia, FDA, DSM-IV codes, Food, Pharmaceutical industry

SEATTLE, March 29, 2024 /PRNewswire/ -- Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) for its first in vitro diagnostic Key Proteo Newborn Screening Kit. The novel proteomics-based screening panel addresses a critical, unmet need to aid in the early identification of four treatable rare genetic disorders that current newborn screening programs do not typically test for, including Wilson Disease (WD), Wiskott-Aldrich Syndrome (WAS), X-linked Agammaglobulinemia (XLA) and Adenosine Deaminase Deficiency (ADA). Early screening has the potential to enable timely intervention that can help change the clinical trajectory and relieve the burden of disease for patients and their families afflicted by these potentially devastating disorders.

Key Points: 
  • The submission of Key Proteo's Newborn Screening Kit 1 comes after screening over 22,000 newborn samples in an ongoing pilot study in Washington state.
  • Subsequently, Key Proteo successfully completed a clinical study that included 3,294 newborn samples analyzed at 3 sites across North America.
  • The in vitro diagnostic Key Proteo Newborn Screening Kit 1 will only be available for commercialization once the FDA has completed its process.
  • Currently, Key Proteo Newborn Screening Kit 1 is available as an RUO offering.