SOPHiA GENETICS SA Ordinary Shares - SOPH STOCK NEWS

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) reported Q2 2024 financial results, showing mixed performance. Revenue increased 5% year-over-year to $15.8 million, with constant currency revenue excluding COVID-19 up 7% to $16.0 million. Gross margins improved to 68.2% (reported) and 73.2% (adjusted), up from 66.7% and 70.0% respectively in the prior year.

The company saw strong growth in the U.S. market but faced challenges in BioPharma and EMEA regions. Operating loss improved by 25% to $15.0 million (reported) and 32% to $9.9 million (adjusted). For the full year 2024, SOPHiA GENETICS revised its revenue outlook to $65-$67 million, representing 4-7% growth, and expects adjusted gross margin between 72.0-72.5%.

SOPHiA GENETICS (Nasdaq: SOPH) announced that L'hôpital Universitaire Avicenne in Bobigny, France, is implementing the SOPHiA DDM™ Platform to enhance its testing and research of blood-related cancers and disorders. The hospital, serving approximately 500,000 patients annually, will use the platform to expand its lymphoid testing, advancing research and treatment planning for blood disorders and cancers.

The SOPHiA DDM™ Platform utilizes next-generation sequencing (NGS) to target key variants from various samples, aiding in better detection of disease-associated variants. The platform's AI-based technology facilitates fast and accurate analysis of genomic data, providing nearly 100% reproducible results to ensure stable and trustworthy sequencing data.

SOPHiA GENETICS (Nasdaq: SOPH) announced an expanded relationship with OncoHelix, a Canada-based research and diagnostics laboratory. OncoHelix will implement MSK-ACCESS® powered with SOPHiA DDM™, becoming the first laboratory in Canada to adopt this liquid biopsy solution. This expansion builds on OncoHelix's existing use of the SOPHiA DDM™ Platform for myeloid testing.

The new liquid biopsy solution will advance OncoHelix's oncology testing capabilities, offering an alternative to traditional solid tumor biopsy. It extracts cell-free DNA from blood plasma, revealing circulating tumor DNA, which can expedite clinical decisions and streamline monitoring. The implementation is expected to go live later this summer, supporting OncoHelix's mission to offer exceptional clinical-grade molecular and immune profile testing.

SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company specializing in data-driven medicine, has announced the release date for its second quarter 2024 financial results. The results will be unveiled on August 6, 2024, before U.S. markets open. Following the release, the company will host a conference call at 8:00 a.m. EDT / 2:00 p.m. CET to discuss the financial results and provide a business outlook. Investors and interested parties can access the webcast live on the SOPHiA GENETICS Investor Relations Website, where a replay will also be available after the call.

SOPHiA GENETICS (Nasdaq: SOPH) has announced that Dhiti Omics Technologies, an India-based precision molecular diagnostics provider, is now live on the SOPHiA DDM™ Platform. This collaboration aims to enhance Dhiti Omics' capabilities in solid tumor testing by utilizing SOPHiA DDM™ for the Agilent SureSelect Cancer Comprehensive Genomic Profiling (CGP) application. The integration is expected to provide researchers with actionable information on mutations and biomarkers across hundreds of genes, ensuring rapid and accurate diagnostics. Both companies emphasize this partnership's potential in advancing precision medicine and improving health outcomes in India and globally.

SOPHiA GENETICS (Nasdaq: SOPH), a leader in data-driven medicine, announced the results of its 2024 Annual General Meeting (AGM) held on June 24, 2024. Shareholders approved all proposals presented during the meeting held at the company's headquarters in Rolle, Switzerland. Detailed voting results and AGM minutes will be available on the company's website and filed with the U.S. Securities and Exchange Commission on Form 6-K. SOPHiA GENETICS expressed gratitude to its shareholders for their support.

SOPHiA GENETICS has announced the launch of its new Residual Acute Myeloid (RAM) Application, aimed at enhancing measurable residual disease (MRD) testing. This application is designed to support the monitoring of Acute Myeloid Leukemia (AML), one of the most common types of leukemia in adults. Over 50% of AML patients relapse within three years of remission, making post-treatment monitoring critical. The RAM Solution, part of SOPHiA's DDM Platform, offers next-generation sequencing (NGS)-based MRD testing with high sensitivity, detecting one cancer cell among 10,000. This tool provides longitudinal variant monitoring, comprehensive MRD reports, and rapid results within four days. The solution will be available globally this summer and aims to improve patient outcomes by detecting early signs of relapse.

SOPHiA GENETICS (Nasdaq: SOPH) has announced that Kepler Uniklinikum, Austria's second largest hospital, has gone live with its SOPHiA DDM™ Platform. The hospital will use this platform to enhance its next-generation sequencing (NGS) testing and diagnostics specifically for blood cancers. Kepler Uniklinikum, housing 1,800 beds, aims to deepen its in-house NGS testing capabilities and expand services for patients with blood cancers and disorders. The SOPHiA DDM™ Platform provides nearly 100% reproducible results, supporting timely, cost-effective, and reliable sequencing data to aid in the rapid and accurate detection of genomic variants. This move is expected to benefit not only the local population but also provide valuable insights to other users of the platform globally.