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. "We are excited to lead the charge towards changing the clinical course of treatable rare genetic disorders that are currently being missed," said Mark Willig, President and CEO of Key Proteo. "Enhanced early screening is key to enabling clinical interventions that can significantly help reduce morbidity and mortality. I am extremely proud of the tireless efforts that our team has made over the past five years to reach this important milestone not just for our company, but for the patients and their families that will benefit from these life-altering screening tools." With its initial focus on addressing unmet needs for WD, WAS, XLA and ADA in the newborn screening space, nearly 100 treatable genetic disorders have been identified that could potentially be adapted to Key Proteo's dynamic proteomics-based platform. 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. In parallel path, Key Proteo is also expanding its operations to include a CLIA-certified laboratory to serve unaddressed newborn screening needs among public health laboratories, reference laboratories, hospital laboratories and other providers associated with neonatal care that may prefer to send-out for these and other critically important newborn screening tests. Wilson Disease, affecting approximately 1 in 30,000 individuals, is characterized by excess copper accumulation in the liver, brain, and eyes, and can lead to liver disease, central nervous system dysfunction and death. Timely diagnosis and treatment are vital to prevent long-term disability and life-threatening complications. X-linked Agammaglobulinemia, impacting around 1 in 250,000 individuals, mainly males, is marked by severely low immunoglobulin levels. Typically, symptoms manifest as recurrent bacterial infections from around 6 months of age, with commonly diagnosed infections including lung, ear, sinus, eye, and skin infections, along with those linked to chronic diarrhea. Key Proteo is on a mission to save lives and relieve the burden of disease for patients and their families afflicted by rare but treatable genetic disorders through early screening. Many treatable genetic disorders are difficult to detect, but when found early, intervention can be enabled to help change the clinical course. With its initial focus on newborns, Key Proteo's dynamic proteomics-based platform can be adapted to screen for rare but treatable genetic disorders across other patient populations. Key Proteo's patent-pending Immuno-SRM platform and associated reagent kits can perform targeted proteomic analysis of extremely low abundance peptide biomarkers from a few drops of blood. This proprietary 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 (NGS). FORWARD-LOOKING STATEMENTS
Certain information contained in this press release constitutes forward-looking statements. These forward-looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated. Forward-looking statements represent the Company's estimates only as of the date such statements are made and the Company undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Readers are cautioned that forward-looking statements are not guarantees of future performance and are cautioned not to place undue reliance on any forward-looking statements.
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