EYSINS, Switzerland,
July 29, 2024 /PRNewswire/ -- AliveDx
("Company") is proud to announce it has received IVDR CE mark for
its groundbreaking microarray immunoassay, designed for the
detection of a specific IgE directed to a protein allergen in human
serum. This is the Company's first product for the evaluation of
allergies, enhancing its portfolio of products beyond
autoimmunity.
This immunoassay, run on AliveDx's proprietary MosaiQ® platform,
is an important milestone for the current development of the
Company's multiplex immunoassay microarray, which aims to
simultaneously detect 30+ allergens, including inhalant and food
allergens.
The multiplex immunoassay microarray technology marks a
significant advancement in diagnostics by enabling simultaneous
testing for multiple conditions. This approach streamlines the
identification process, simplifies laboratory workflows, and
reduces the hands-on time required with singleplex methods. As a
result, both laboratories and clinicians save valuable time and can
detect and rule out various conditions more efficiently. For
patients sensitized to multiple allergens (polysensitized), this
technology targets a fast, thorough diagnosis and more targeted
treatment.
"The new multiplex immunoassay will provide a detailed analysis
of an individual's allergic sensitization by testing specific IgE
to a wide array of allergens in a single test. This comprehensive
approach will help optimize laboratory workflows, and help
clinicians obtain a complete picture of their patient's atopic
sensitization profile," said Christian
Fischer, Chief Scientific & Medical Officer at
AliveDx.
The MosaiQ platform is already CE marked for autoimmune disease
screening. Receiving a first IVDR CE mark in the Allergy category
reaffirms AliveDx's dedication to expanding its MosaiQ® offering
and aiding the millions of people worldwide who suffer from
allergies.
This milestone highlights the Company's commitment to
establishing itself as a key player in both the Allergy and
Autoimmune sectors. It also underscores the flexibility and
versatility of the MosaiQ platform. AliveDx anticipates expanding
its panels in both segments in the coming months and partnering
with distributors throughout the world.
"This is a memorable moment in the history of AliveDx. Patients
will soon be able to receive results for multiple allergens from a
single blood sample, reducing the need for multiple tests and
visits. For the medical community, this means having access to an
efficient and cost-effective solution, which consolidates multiple
tests into one. We look forward to supporting patients around the
world, and helping them get appropriate treatment sooner," said
Manuel O. Méndez, CEO of AliveDx.
About AliveDx
At AliveDx, our mission is to empower
diagnostic insights, transform patient care, and innovate for life.
With over 30 years in in-vitro diagnostics, we aim to advance the
future of diagnostics worldwide. We prioritize the health of
patients and create innovative solutions that enable laboratories
and clinicians to shorten the time to diagnosis. Our brands aim to
create both economical and clinical value. We achieve this by
simplifying laboratory workflows and delivering fast and accurate
results that streamline clinical decision-making. At AliveDx, we
innovate for life. We collaborate with laboratorians, clinicians,
patient advocacy groups, academic institutions, and industry
partners. When we feel 'alive', we do more than just live. Feeling
alive is giving purpose, meaning and energy to our communities, our
work and ourselves.
About the MosaiQ platform
MosaiQ® is a fully automated high-throughput platform that
streamlines multiplex testing for Autoimmune, Allergy, and beyond.
This intuitive platform delivers fast and accurate results using
advanced microarray panels to rapidly detect and identify disease
markers—maximizing workflow efficiencies, simplifying pathways, and
helping shorten time to diagnosis.
For more information about AliveDx and its IVD solutions, please
visit www.alivedx.com or connect with us on LinkedIn and X.
©AliveDx Suisse SA. 2024. The AliveDx logo, AliveDx and MosaiQ
are trademarks or registered trademarks of AliveDx group companies
in various jurisdictions. Menus and capabilities are subject to
change. Not all methods may be available in all territories.
Subject to regulatory clearance.
View original
content:https://www.prnewswire.co.uk/news-releases/alivedx-receives-ivdr-ce-mark-for-groundbreaking-microarray-immunoassay-in-allergy-diagnostics-302207844.html