Potential to be the first IVD for the screening of Wilson
Disease, Wiskott-Aldrich Syndrome, X-linked Agammaglobulinemia and
Adenosine Deaminase Deficiency
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.
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.
ABOUT WILSON DISEASE, WISKOTT-ALDRICH SYNDROME, XLA and
ADA
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.
Impacting 1 in 100,000, Wiskott-Aldrich Syndrome is
characterized by immunodeficiency and impaired blood clotting.
Symptoms include bruising, susceptibility to infections and immune
and inflammatory disorders, and heightened cancer risk. Eczema
often accompanies the syndrome. WAS patients face increased
vulnerability to infections, bleeding, and cancers, often leading
to premature mortality.
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.
Adenosine Deaminase Deficiency (ADA), impacting roughly 1 in
500,000 individuals, is a primary cause of severe combined
immunodeficiency (SCID), impairing the body's ability to combat
infections. Symptoms typically emerge before 6 months, ranging from
pneumonia to chronic diarrhea and delayed development. While most
symptoms surface early, some may manifest later in life.
ABOUT KEY PROTEO
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.
For more information, visit www.keyproteo.com.
#KeyProteo #DeNovoClassification #NewbornScreening #RareDisease
#WilsonDisease #WilsonDiseaseAssociation #WiskottAldrichSyndrome
#XLA #AdenosineDeaminaseDeficiency #ImmuneDeficiencyFoundation
#Proteomics #Biotech #VentureCapital #LifeSciences #HealthTech
#BioTechNews
CONTACT
Sean Sandin
Chief Operating Officer
info@keyproteo.com
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SOURCE Key Proteo