September 25, 2024 | QIAGEN has entered a collaboration with Eli Lilly to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes; Illumina welcomed the European Court of Justice's judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL; Ambry Genetics announced enhancements to their portfolio of tests for the detection of genetic mutations associated with hereditary cancer; and more.
Illumina welcomed the European Court of Justice's (ECJ's) judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL. This judgment confirms Illumina's longstanding view that the European Commission exceeded its authority by asserting jurisdiction over this merger. The basis for the €432 million fine has now been removed and will no longer be payable. Following Illumina's spin-off of GRAIL in June 2024, GRAIL is now an independent public company. Press release.
Roche announced the launch of the cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology uses multiplex polymerase chain reaction (PCR) testing, combined with color, temperature, and data processing, to identify as many as 15 pathogens in a single PCR test. Typically, PCR tests on a high throughput analyzer can identify four results in a single test. TAGS technology makes it possible to increase this number to fifteen. The cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses, including influenza A, influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2, within a patient sample using a single PCR test. The test also allows clinicians to specify which pathogens to look for using pre-selected targets. Press release.
Researchers at the Icahn School of Medicine at Mount Sinai have developed an advanced artificial intelligence (AI)-driven tool to improve the management and prognosis of prostate cancer. Details on the findings were reported in the September 20 online issue of European Urology (DOI: 10.1016/j.eururo.2024.07.013). The tool, PATHOMIQ_PRAD is designed for patients with intermediate-risk prostate cancer and uses deep learning to extract morphological features from datasets derived from biopsy or surgical hematoxylin- and eosin-stained whole-slide images. It aims to identify those at higher risk of rapid disease progression and provide more timely, accurate predictions for earlier interventions and more targeted, personalized, treatment plans. Press release.
Previse announced the publication of a study in Diagnostics (DOI: 10.3390/diagnostics14182003)highlighting the analytical validation of Esopredict, a first-in-class DNA methylation test for identifying patients with precancerous Barrett's esophagus (BE) who are likely to progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in the future. Study results demonstrate that Esopredict performs to the utmost validation standards with high repeatability and reproducibility, as well as high analytical sensitivity and specificity. Press release.
Ambry Genetics announced enhancements to their portfolio of tests for the detection of genetic mutations associated with hereditary cancer. This new evidence-informed menu builds on the company’s 12-year history in hereditary cancer testing, to offer tests reflecting the latest scientific evidence and national consensus guidelines. Changes to the portfolio include: updated test panels informed by national consensus guidelines—CancerNext, BRCANext, and ColoNext—include genes for which there are clear management guidelines to maximize clinical utility; additional genes and additional indications for more comprehensive genetic assessment; and portfolio enhancements to improve flexibility and clinician ease-of-use, such as new add-on options for limited evidence genes. Press release.
QIAGEN entered a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes, which can play a role in the diagnosis of Alzheimer’s disease. This collaboration represents a significant milestone as the QIAstat-Dx panel would be the first commercially available IVD for APOE genotyping. The panel will be integrated with QIAGEN's multiplex testing platform QIAstat-Dx, marking the first publicly disclosed collaboration for a clinical application of the system in neurodegenerative diseases and adding to two more collaborations for diagnostics development programs with other companies. The QIAstat-Dx IVD panel will detect all APOE genotypes (APOE2, APOE3, APOE4). They can play a role in the diagnosis of patients with Alzheimer's disease, which is the most common cause of dementia. Press release.
Viz.ai and Cleerly have partnered up to bring Cleerly into the Viz.ai One platform to improve and expedite the coordination of care for patients with heart disease, the leading cause of death worldwide. Cleerly has pioneered the development of several leading FDA-approved softwares that use coronary computed tomography angiography (CCTA) images with advanced AI algorithms to detect ischemia and stenosis, and identify, quantify, and categorize plaque. The Viz.ai One platform continues to expand its suite of AI-powered capabilities for cardiology, including advanced features such as electrocardiogram (ECG) AI, echocardiogram (echo) AI, chest CT visualization and AI, team activation, and HIPAA-compliant communication. Press release.
Seegene has partnered up with Springer Nature to launch ‘Nature Awards MDx Impact Grants in partnership with Seegene’, a new project for the development of diagnostic assays. The program empowers researchers worldwide to develop innovative diagnostic assays using Seegene’s advanced multiplex PCR technology. This year’s call invites scientists across the globe to directly propose product development ideas. Researchers are required to submit proposals featuring qualitative PCR-based analysis targeting human infectious diseases. Selected final awardees will receive significant support, including research funding of up to $600,000 per project, as well as Seegene’s provision of syndromic PCR assays, extraction assays, consumables, instruments, and relevant software necessary for their clinical research project. Press release.
PathAI announced that its AISight Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis. The CE mark paves the way for the company's expansion in the European diagnostic pathology market, enhancing pathologists' interpretations and driving efficiencies and quality improvements within anatomic pathology laboratories. AISight Dx is a robust digital pathology platform meticulously designed with input from over 200 pathologists to streamline end-to-end digital pathology workflows. It offers a suite of features including best-in-class caseload balancing and assignment, image ingestion, image viewing, collaboration tools, and image and case management. The platform can also integrate bi-directionally with laboratory information systems through AISight Link, further enhancing workflow efficiency. Press release.