Regulatory milestone validates the SOPHiA DDM™
Platform as diagnostic tool in select markets
BOSTON and ROLLE, Switzerland, Aug. 14,
2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq:
SOPH), a cloud-native healthcare technology company and a global
leader in data-driven medicine, today announced that its
SOPHiA DDM™ Platform is now CE marked under the European Union's In
Vitro Diagnostic Regulation (IVDR). IVDR certification is a
significant regulatory milestone that validates the powerful
analytical capabilities of the SOPHiA DDM™ Platform and allows
customers throughout the European Union and other markets
recognizing this certification to use the SOPHiA DDM™ Platform to
support patient diagnostics.
The transition from the In Vitro Diagnostic Directive (IVDD) to
the IVDR in the European Union marks an important advancement in
regulatory standards for genetic testing and analysis, including
software used for analysis. The new standards promote transparency
and traceability throughout genomic analysis processes, helping to
ensure the reliability and accuracy of diagnostic results and
ultimately patient safety. Users can save time and costs by
leveraging an IVDR compliant software platform, like SOPHiA
DDM™.
"At SOPHiA GENETICS, certification of our SOPHiA DDM™ Platform
under IVDR builds on our track record of offering a broad set of
CE-IVD applications and giving our customers confidence in knowing
they are using a cutting-edge, compliant Platform for their
analysis needs," said Daan Van Well,
LL.M., M.B.A., Chief Legal and Compliance Officer SOPHiA GENETICS. "This was a top priority for
our team to ensure a seamless transition for our current CE-IVD
customers so they can continue to use the SOPHiA DDM™ Platform to
support diagnosis and treatment decisions for patients facing
cancer."
The IVDR registration certifies that the SOPHiA DDM™ Platform's
genetic analysis meets the European IVDR 2017/746 requirements,
which govern the sale of in vitro diagnostic devices within the
European Economic Area. The SOPHiA DDM™ Platform offers "Dx Mode"
in order to satisfy IVDR requirements.
Powered by SOPHiA GENETICS' proprietary deep learning
algorithms, the SOPHiA DDM™ Platform supports state-of-the-art
oncology technologies, including five existing CE-IVD SOPHiA DDM™
applications. The Platform uses the collective intelligence
gathered by SOPHiA GENETICS' global network of partners and, to
date, has facilitated the analysis of more than 1.7 million genomic
profiles.
For more information on SOPHiA GENETICS,
visit SOPHiAGENETICS.com and connect on LinkedIn.
About SOPHiA GENETICS
SOPHiA GENETICS (Nasdaq: SOPH) is a cloud-native healthcare
technology company on a mission to expand access to
data-driven medicine by using AI to deliver world-class care to
patients with cancer and rare disorders across the globe.
It is the creator of the SOPHiA DDM™ Platform, which analyzes
complex genomic and multimodal data and
generates real-time, actionable insights for a broad
global network of hospital, laboratory, and biopharma
institutions. For more information,
visit SOPHiAGENETICS.com and connect with us
on LinkedIn.
SOPHiA DDM™ Dx HRD Solution, SOPHiA DDM™ Dx Myeloid
Solution, SOPHiA DDM™ Dx Hereditary Cancer Solution, SOPHiA DDM™ Dx
Solid Tumour Solution, and SOPHiA DDM™ Dx RNAtarget Oncology
Solution are available as CE-IVD products for In Vitro Diagnostic
Use in Europe and Turkey. The information in this press release
is about products that may or may not be available in different
countries and, if applicable, may or may not have received approval
or market clearance by a governmental regulatory body for different
indications for use. Please
contact support@sophiagenetics.com to obtain the
appropriate product information for your country of
residence.
SOPHiA GENETICS Forward-Looking Statements:
This press release contains statements that constitute
forward-looking statements. All statements other than statements of
historical facts contained in this press release, including
statements regarding our future results of operations and financial
position, business strategy, products, and technology, as well as
plans and objectives of management for future operations, are
forward-looking statements. Forward-looking statements are based on
our management's beliefs and assumptions and on information
currently available to our management. Such statements are subject
to risks and uncertainties, and actual results may differ
materially from those expressed or implied in the forward-looking
statements due to various factors, including those described in our
filings with the U.S. Securities and Exchange Commission. No
assurance can be given that such future results will be achieved.
Such forward-looking statements contained in this press release
speak only as of the date hereof. We expressly disclaim any
obligation or undertaking to update these forward-looking
statements contained in this press release to reflect any change in
our expectations or any change in events, conditions, or
circumstances on which such statements are based, unless required
to do so by applicable law. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
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SOURCE SOPHiA GENETICS