SOPHiA DDM™ Platform Certified Under IVDR
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.
SOPHiA GENETICS (Nasdaq: SOPH) ha annunciato che la sua SOPHiA DDM™ Platform ha ricevuto la marcatura CE secondo il Regolamento sui Dispositivi Medici per Diagnostica In Vitro (IVDR) dell'Unione Europea. Questa certificazione valida le capacità analitiche della piattaforma e ne consente l'uso per la diagnostica dei pazienti nell'UE e in altri mercati che riconoscono questa certificazione.
La transizione da IVDD a IVDR rappresenta un avanzamento significativo negli standard normativi per il testing genetico e l'analisi. La certificazione IVDR della SOPHiA DDM™ Platform garantisce la conformità a questi nuovi standard, promuovendo la trasparenza, la tracciabilità e l'affidabilità nei processi di analisi genomica.
La piattaforma offre una 'Modalità Dx' per soddisfare i requisiti IVDR e include cinque applicazioni CE-IVD esistenti. Alimentata da algoritmi proprietari di deep learning, ha facilitato finora l'analisi di oltre 1,7 milioni di profili genomici.
SOPHiA GENETICS (Nasdaq: SOPH) ha anunciado que su SOPHiA DDM™ Platform ha recibido la marca CE bajo el Reglamento de Diagnósticos In Vitro (IVDR) de la Unión Europea. Esta certificación valida las capacidades analíticas de la plataforma y permite su uso para diagnósticos de pacientes en la UE y otros mercados que reconocen esta certificación.
La transición de IVDD a IVDR representa un avance significativo en los estándares regulatorios para pruebas y análisis genéticos. La certificación IVDR de la SOPHiA DDM™ Platform asegura el cumplimiento de estos nuevos estándares, promoviendo la transparencia, la trazabilidad y la fiabilidad en los procesos de análisis genómico.
La plataforma ofrece un 'Modo Dx' para cumplir con los requisitos IVDR e incluye cinco aplicaciones CE-IVD existentes. Impulsada por algoritmos de aprendizaje profundo patentados, ha facilitado hasta la fecha el análisis de más de 1.7 millones de perfiles genómicos.
SOPHiA GENETICS (Nasdaq: SOPH)는 SOPHiA DDM™ Platform이 유럽연합의 체외 진단 규정 (IVDR)에 따라 CE 인증을 받았다고 발표했습니다. 이 인증은 플랫폼의 분석 능력을 검증하며, EU 및 이 인증을 인정하는 기타 시장에서 환자 진단을 위해 사용될 수 있도록 합니다.
IVDD에서 IVDR로의 전환은 유전자 검사 및 분석에 대한 규제 기준의 중요한 발전을 나타냅니다. SOPHiA DDM™ Platform의 IVDR 인증은 이러한 새로운 기준을 준수함을 보장하며, 유전체 분석 과정에서의 투명성, 추적 가능성 및 신뢰성을 촉진합니다.
이 플랫폼은 IVDR 요구 사항을 충족하기 위해 'Dx 모드'를 제공하며, 기존의 다섯 개 CE-IVD 응용 프로그램을 포함하고 있습니다. 독점적인 딥 러닝 알고리즘을 활용하여 현재까지 170만 개 이상의 유전적 프로필 분석을 용이하게 했습니다.
SOPHiA GENETICS (Nasdaq: SOPH) a annoncé que sa SOPHiA DDM™ Platform a reçu le marquage CE conformément au Règlement sur les dispositifs médicaux de diagnostic in vitro (IVDR) de l'Union Européenne. Cette certification valide les capacités analytiques de la plateforme et permet son utilisation pour le diagnostic des patients dans l'UE et d'autres marchés reconnaissant cette certification.
La transition de l'IVDD à l'IVDR représente une avancée significative dans les normes réglementaires pour le test et l'analyse génétiques. La certification IVDR de la SOPHiA DDM™ Platform garantit la conformité à ces nouvelles normes, favorisant la transparence, la traçabilité et la fiabilité des processus d'analyse génomique.
La plateforme propose un 'Mode Dx' pour répondre aux exigences de l'IVDR et comprend cinq applications CE-IVD existantes. Alimentée par des algorithmes d'apprentissage profond propriétaires, elle a facilité jusqu'à présent l'analyse de plus de 1,7 million de profils génomiques.
SOPHiA GENETICS (Nasdaq: SOPH) hat angekündigt, dass seine SOPHiA DDM™ Platform die CE-Kennzeichnung gemäß der Verordnung über In-vitro-Diagnosetests (IVDR) der Europäischen Union erhalten hat. Diese Zertifizierung bestätigt die analytischen Fähigkeiten der Plattform und ermöglicht ihre Verwendung zur Patienten-Diagnose in der EU und anderen Märkten, die diese Zertifizierung anerkennen.
Der Übergang von IVDD zu IVDR stellt einen signifikanten Fortschritt in den regulatorischen Standards für genetische Tests und Analysen dar. Die IVDR-Zertifizierung der SOPHiA DDM™ Platform stellt die Einhaltung dieser neuen Standards sicher und fördert Transparenz, Rückverfolgbarkeit und Zuverlässigkeit in den Prozessen der genomischen Analyse.
Die Plattform bietet einen 'Dx-Modus', um die Anforderungen der IVDR zu erfüllen, und umfasst fünf bestehende CE-IVD-Anwendungen. Angetrieben von proprietären Deep-Learning-Algorithmen hat sie bis heute die Analyse von über 1,7 Millionen genomischen Profilen erleichtert.
- 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
- None.
Insights
The IVDR certification for SOPHiA DDM™ Platform is a significant milestone in the genomic analysis landscape. This regulatory approval enhances the platform's credibility for diagnostic use in the EU and other markets recognizing this certification. The transition from IVDD to IVDR represents a higher standard for genetic testing, emphasizing transparency and traceability.
The platform's "Dx Mode" feature, compliant with IVDR 2017/746 requirements, positions SOPHiA GENETICS favorably in the competitive medical diagnostics market. With 5 existing CE-IVD applications and analysis of over 1.7 million genomic profiles, the platform demonstrates substantial market penetration and reliability. This certification could potentially accelerate adoption among healthcare providers and research institutions, boosting the company's market share in the growing field of personalized medicine.
The IVDR certification for SOPHiA DDM™ Platform is a crucial regulatory achievement. It signifies compliance with the EU's stringent new standards for in vitro diagnostic devices, which is more comprehensive than the previous IVDD. This certification not only allows SOPHiA GENETICS to maintain its market presence in the EU but also provides a competitive edge over non-certified platforms.
The "Dx Mode" feature demonstrates the company's proactive approach to regulatory compliance. This certification may also streamline future approvals in other jurisdictions that recognize EU standards. However, maintaining IVDR compliance requires ongoing vigilance and may necessitate additional resources for continuous monitoring and updates to meet evolving regulatory requirements.
The IVDR certification for SOPHiA DDM™ Platform opens up significant market opportunities for SOPHiA GENETICS. It allows the company to expand its customer base in the EU and other markets that recognize this certification. The platform's ability to support diagnosis and treatment decisions in oncology positions it well in the high-growth personalized medicine market.
The certification may lead to increased adoption rates among healthcare providers looking for compliant, time-saving solutions. With over 1.7 million genomic profiles analyzed, the platform has demonstrated scalability and market acceptance. However, the company may face increased competition as other players seek IVDR certification. SOPHiA GENETICS will need to leverage its first-mover advantage and continue innovating to maintain its market position in this rapidly evolving sector.
Regulatory milestone validates the SOPHiA DDM™ Platform as diagnostic tool in select markets
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
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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
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FAQ
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