CENTOGENE N.V. (Nasdaq: CNTG) (the “Company”), the essential life
science partner for data-driven answers in rare and
neurodegenerative diseases, today announced data confirming the
utility of lyso-Gb1 (glucosylsphingosine) as a sensitive biomarker
for Gaucher disease (GD). The findings from this landmark study
which were published in Diagnostics in a paper titled, “Insights
into the value of lyso-Gb1 as a predictive biomarker in
treatment-naïve patients with Gaucher disease type 1 in the
LYSO-PROOF study,” also indicate lyso-Gb1 could help to predict the
clinical course of patients and improve personalized care of GD
patients in the future.
“Over the past decade, we have leveraged all our multiomic
technological know-how to establish and confirm lyso-Gb1 as the
best biomarker for Gaucher disease,” said Professor Peter Bauer,
CENTOGENE’s Chief Medical and Genomic Officer. “This landmark study
further advances our understanding of Gaucher disease patients –
demonstrating a significant correlation between lyso-Gb1 levels and
disease severity. The combination of state-of-the-art multiomic
testing with access to data from our diverse, real-world CENTOGENE
Biodatabank provides the essential link between genetic variants
and actionable clinical information.”
The study, which included 160 treatment-naïve GD patients from
Israel, Russia, Pakistan, Egypt, Iran, Morocco, Algeria, India,
Spain, Albania, Greece, Sweden, Columbia, and Tunisia, is one of
the largest studies to examine Gaucher patients who have never
received disease-specific treatment.
CENTOGENE utilized CentoCard®, the Company’s proprietary,
CE-marked dried blood spot (DBS) collection kit in combination with
state-of-the-art biochemical and sequencing technologies to screen
for mutations in the GBA1 gene and establish a GD diagnosis. The
insights gained were powered by the CENTOGENE Biodatabank, the
world’s largest real-world integrated multiomic data repository in
rare and neurodegenerative diseases.
The results of the study revealed a highly significant
correlation between lyso-Gb1 and disease severity in all Gaucher
patients, including those with novel rare GBA1 variants.
“This important international study has helped to set the
standard for Gaucher disease care – from diagnosis and prognosis to
treatment and monitoring,” said Tobias Böttcher, M.D., Director of
Clinical Neurogenetics at CENTOGENE. “The progressive increase in
lyso-Gb1 levels in untreated Gaucher patients suggests that these
patients could benefit from treatment, such as enzyme replacement
therapy. The biomarker, combined with diagnostic and sequencing
technologies, provides physicians with the tool to establish the
best therapeutic strategies for each individual patient, which
could significantly improve their quality of life.”
To read the full study, visit:
https://link.centogene.com/lyso-gb1-publication
About Gaucher Disease
Gaucher disease (GD) is a rare inherited lysosomal storage
disorder (LSD) that affects the body's ability to break down a type
of fat called glucocerebroside. This results in the accumulation of
this fat within cells, particularly in the liver, spleen, and bone
marrow. GD can cause a wide range of symptoms, including
enlargement of the liver and spleen, anemia, bone pain, and
increased susceptibility to fractures. There are different types of
GD, and the severity of symptoms can vary greatly. Treatment
options may include enzyme replacement therapy to help break down
the accumulated fat and manage the associated symptoms. Early
diagnosis and appropriate management are essential to improve the
quality of life for patients with GD.
About Lyso-Gb1
Lyso-Gb1, also known as glucosylsphingosine, is a biomarker
associated with Gaucher disease (GD). Elevated levels of lyso-Gb1
in the blood and other tissues can indicate the presence of GD and
help in its diagnosis and monitoring, as well as proactively
predicting disease course. This biomarker plays a crucial role in
assessing the severity of the disease and guiding treatment
decisions for affected individuals.
Due to its utility, lyso-Gb1 could be used as a particularly
valuable addition in Newborn Screening programs to shorten the
diagnostic delay in GD.
Lyso-Gb1 is one of CENTOGENE’s commercialized, proprietary
biomarkers, which has patents globally, including in the U.S.,
Europe, and Asia.
About CENTOGENE
CENTOGENE’s mission is to provide data-driven, life-changing
answers to patients, physicians, and pharma companies for rare and
neurodegenerative diseases. We integrate multiomic technologies
with the CENTOGENE Biodatabank – providing dimensional analysis to
guide the next generation of precision medicine. Our unique
approach enables rapid and reliable diagnosis for patients,
supports a more precise physician understanding of disease states,
and accelerates and de-risks targeted pharma drug discovery,
development, and commercialization.
Since our founding in 2006, CENTOGENE has been offering rapid
and reliable diagnosis – building a network of approximately 30,000
active physicians. Our ISO, CAP, and CLIA certified multiomic
reference laboratories in Germany utilize Phenomic, Genomic,
Transcriptomic, Epigenomic, Proteomic, and Metabolomic datasets.
This data is captured in our CENTOGENE Biodatabank, with over
750,000 patients represented from over 120 highly diverse
countries, over 70% of whom are of non-European descent. To date,
the CENTOGENE Biodatabank has contributed to generating novel
insights for more than 275 peer-reviewed publications.
By translating our data and expertise into tangible insights, we
have supported over 50 collaborations with pharma partners.
Together, we accelerate and de-risk drug discovery, development,
and commercialization in target & drug screening, clinical
development, market access and expansion, as well as offering
CENTOGENE Biodata Licenses and Insight Reports to enable a world
healed of all rare and neurodegenerative diseases.
To discover more about our products, pipeline, and
patient-driven purpose, visit www.centogene.com and follow us
on LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. federal securities laws. Statements
contained herein that are not clearly historical in nature are
forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” “plan,” “is
designed to,” “potential,” “predict,” “objective” and similar
expressions and future or conditional verbs such as “will,”
“would,” “should,” “could,” “might,” “can,” and “may,” or the
negative of these are generally intended to identify
forward-looking statements. Such forward-looking statements involve
known and unknown risks, uncertainties, and other important factors
that may cause CENTOGENE’s actual results, performance, or
achievements to be materially different from any future results,
performance, or achievements expressed or implied by the forward-
looking statements. Such risks and uncertainties include, among
others, negative economic and geopolitical conditions and
instability and volatility in the worldwide financial markets,
possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition
and consolidation in our industry, the expense and uncertainty of
regulatory approval, including from the U.S. Food and Drug
Administration, our reliance on third parties and collaboration
partners, including our ability to manage growth, execute our
business strategy and enter into new client relationships, our
dependency on the rare disease industry, our ability to manage
international expansion, our reliance on key personnel, our
reliance on intellectual property protection, fluctuations of our
operating results due to the effect of exchange rates, our ability
to streamline cash usage, our continued ongoing compliance with
covenants linked to financial instruments, our requirement for
additional financing and our ability to continue as a going
concern, or other factors. For further information on the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to CENTOGENE’s business in general, see CENTOGENE’s risk
factors set forth in CENTOGENE’s Form 20-F filed on May 16, 2023,
with the Securities and Exchange Commission (the “SEC”) and
subsequent filings with the SEC. Any forward- looking statements
contained in this press release speak only as of the date hereof,
and CENTOGENE specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
CONTACT
CENTOGENE
Melissa HallCorporate Communications Press@centogene.com
Lennart StreibelInvestor Relations IR@centogene.com
Centogene NV (NASDAQ:CNTG)
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