Key Proteo Announces Clinical Laboratory Expansion Plans Including New CLIA-Certified Laboratory

Plans initiated to build new CLIA-certified laboratory for early detection of treatable genetic disorders in newborns

Expanding in-house clinical testing and research capabilities

SEATTLE – March 07, 2024 – Key Proteo, a pioneering proteomics diagnostics company specializing in the early identification of rare but treatable genetic disorders, announced it has initiated plans to build a new CLIA-certified laboratory as part of its initial commercialization and growth strategy to enhance newborn screening programs. The new larger facility and expanded scope of operations will allow Key Proteo to serve unaddressed newborn screening needs among public health laboratories, reference laboratories, hospital laboratories and other providers associated with neonatal care, while maintaining dedicated lab operations for ongoing clinical research and other collaborative opportunities.

Based in Seattle, the new 5,000-square-foot facility will include the addition of a state-of-the art CLIA-certified clinical laboratory alongside Key Proteo’s corporate headquarters and dedicated clinical research facilities. “Our new state-of-the-art CLIA-laboratory will allow us to bring critical, life-altering screening panels to market more quickly to help foster preemptive treatment for devastating but treatable genetic disorders in newborns,” said Mark Willig, Key Proteo’s President and Chief Executive Officer. “Additionally, it will enhance the capabilities of our service offerings that can be tailored to the specific needs of biopharma and research organizations conducting clinical research in support of global gene therapy development initiatives. Our initial focus is on newborn screening, and the novel technology can be adapted to screen for rare but treatable genetic disorders across other patient populations.”

Buildout of the lab has commenced, and, upon launch, Key Proteo’s first newborn screening panel will target four treatable genetic orders including Wilson’s disease, Wiskott-Aldrich syndrome, X-linked a-y-globulinemia and adenosine deaminase (ADA) deficiency. In parallel path, Key Proteo is pursuing FDA De Novo classification of an in vitro diagnostic (IVD) test kit for the same four disorders.

ABOUT CLIA CERTIFICATION

CLIA certification is part of a federal regulatory program (Clinical Laboratory Improvement Amendments) established in 1988 to ensure the accuracy and reliability of laboratory testing performed on humans. The CLIA certification process involves passing a series of inspections to ensure that the respective laboratory is properly staffed, equipped and quality-controlled. Additionally, all laboratory personnel must be properly trained and qualified to perform their tasks. CLIA standards are designed to ensure the accuracy and precision of laboratory testing, and all CLIA-certified laboratories must undergo periodic inspections to ensure they are in compliance with CLIA regulations.

ABOUT KEY PROTEO

Key Proteo is on a mission to relieve suffering and save lives 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 diagnostic 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.

For more information, visit www.keyproteo.com

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CONTACT

Sean Sandin

Director, Business Development

(206) 339-7515

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