SOPHiA DDM™ Platform Certified Under IVDR

Rhea-AI Summary

SOPHiA GENETICS (Nasdaq: SOPH) has announced that its SOPHiA DDM™ Platform has received CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR). This certification validates the platform's analytical capabilities and allows its use for patient diagnostics in the EU and other markets recognizing this certification.

The transition from IVDD to IVDR represents a significant advancement in regulatory standards for genetic testing and analysis. The SOPHiA DDM™ Platform's IVDR certification ensures compliance with these new standards, promoting transparency, traceability, and reliability in genomic analysis processes.

The platform offers a 'Dx Mode' to meet IVDR requirements and includes five existing CE-IVD applications. Powered by proprietary deep learning algorithms, it has facilitated the analysis of over 1.7 million genomic profiles to date.

Positive

• SOPHiA DDM™ Platform received CE marking under IVDR, validating its analytical capabilities
• IVDR certification allows platform use for patient diagnostics in EU and other recognizing markets
• Platform offers 'Dx Mode' to meet IVDR requirements
• SOPHiA DDM™ Platform includes five existing CE-IVD applications
• Platform has facilitated analysis of over 1.7 million genomic profiles

Negative

• None.

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

FAQ

What regulatory certification did SOPHiA GENETICS (SOPH) receive for its SOPHiA DDM™ Platform?

SOPHiA GENETICS received CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR) for its SOPHiA DDM™ Platform.

How does the IVDR certification benefit SOPHiA GENETICS (SOPH) customers?

The IVDR certification allows customers in the EU and other recognizing markets to use the SOPHiA DDM™ Platform for patient diagnostics, saving time and costs by leveraging a compliant software platform.

What is the significance of the transition from IVDD to IVDR for SOPHiA GENETICS (SOPH)?

The transition represents an advancement in regulatory standards for genetic testing and analysis, promoting transparency, traceability, and reliability in genomic analysis processes, which SOPHiA GENETICS' platform now complies with.

How many genomic profiles has the SOPHiA DDM™ Platform analyzed as of August 2024?

As of August 2024, the SOPHiA DDM™ Platform has facilitated the analysis of more than 1.7 million genomic profiles.