August 28, 2024 | Roche announced the completion of the acquisition of LumiraDx’s Point of Care technology; NOWDiagnostics announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know Syphilis Test for OTC use; MAUI Imaging emerged from stealth with the announcement of a $4 million U.S. Department of Defense (U.S. Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care; and more.
Illumina announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications. This single test interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment. TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly's RETEVMO (selpercatinib). Press release.
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced the open comment period for the revised 2018 evidence-based guideline, “Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors.” The open comment period begins from August 22, 2024, and will close on September 12, 2024. The online format provides an opportunity for public review of new draft recommendations for several key topics. The guideline revisions are designed to provide state-of-the-art molecular testing of lung cancer recommendations for pathologists, oncologists, patient advocacy groups, and cancer and molecular diagnostic laboratory professionals. Press release.
Paige announced the launch of OmniScreen, a pioneering AI-driven biomarker module capable of evaluating over 505 genes and detecting 1,228 molecular biomarkers from routine H&E-stained digital pathology slides. Built on Paige’s second-generation foundation model, trained on an unprecedented three million slides, this breakthrough represents a major leap forward in the accuracy, speed, and cost-effectiveness of cancer diagnosis and treatment selection. Unlike traditional methods that require separate models for each biomarker or cancer type, OmniScreen employs a single AI module capable of predicting a broad spectrum of clinically relevant molecular biomarkers across multiple cancer types. Press release.
NOWDiagnostics announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know Syphilis Test for OTC use. First To Know is the first and only rapid syphilis test in the U.S. that provides an in-home result in 15 minutes with a single drop of blood. It has been proven in a clinical study of 1,270 people to be easy to use. The test received marketing authorization from the FDA through the de novo pathway, recognizing it as a novel device for syphilis testing in the United States. Press release.
MAUI Imaging emerged from stealth with the announcement of a $4 million U.S. Department of Defense (U.S. Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care in high volume (mass casualty) and/or resource limited environments. The program is designed to demonstrate that MAUI can improve time to care in trauma patients, ultimately improving outcomes as patients receive lifesaving treatments faster and more effectively, particularly in austere environments, such as in the field, naval vessels, and evacuation aircraft. Press release.
Firefly Neuroscience has formed a strategic partnership with the Neurology Consultants of Dallas (NCD) to help enhance early detection efforts and disease management for patients suffering from cognitive decline. NCD will incorporate Firefly’s Brain Network Analytics (BNA) technology into its patient workflow and conduct clinical studies aimed at identifying biomarkers for predicting the onset of dementia that can potentially optimize patient care pathways. By establishing a baseline for every patient, healthcare providers can more accurately track cognitive changes, which will promote the early detection and effective management of cognitive decline. Press release.
Indica Labs has launched Lung Macrodissect AI, a tool that revolutionizes slide macrodissection and molecular pathology workflows that minimizes human error and improves efficiency. In addition to highlighting cancerous tissue, Lung Macrodissect AI calculates the total number of tumor cells present within an annotated region of interest (ROI) and determines the percentage of tumor present in all annotated ROIs. Press release.
HCLTech announced the launch of an advanced clinical trials and diagnosis solution in collaboration with Denodo and Amazon Web Services (AWS) ecosystem solutions to accelerate the pace of diagnosis and treatment research. This clinical trials and diagnosis solution helps pharmaceutical companies capture comprehensive data insights from the clinical studies, streamlining clinical trials and enabling quicker and better decision-making. The solution enables healthcare providers to efficiently compare new treatments against standard ones, considering varied dosages and demographic impacts through a centralized data model that is secure with real-time access to critical data. Press release.
Sapio Sciences and Zifo announced a strategic partnership to bring best-in-class laboratory information management solutions to customers across the biotech, clinical diagnostics, and pharmaceutical industries. The partnership combines Zifo’s consulting expertise in AI & ML services with Sapio's highly configurable lab informatics platform and expertise in system design, deployment, and integration. The partnership will also see Sapio certify Zifo engineers to ensure joint customers can access highly skilled engineers and solution consultants when deploying Sapio solutions. Press release.
Roche announced the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Through this acquisition, Roche complements its diagnostics portfolio with a simple-to-use platform that consolidates a wide range of immunoassay and clinical chemistry tests on a single instrument, with the future potential to expand into molecular testing. With this, Roche can further expand its offering in decentralized patient care and drive global access to timely and actionable diagnostic results. Press release.
Labcorp announced an expanded collaboration with Ultima Genomics to utilize its UG 100TM sequencing solution and ppmSeq technology to explore new whole genome sequencing (WGS) clinical applications, including molecular residual disease (MRD) in patients with early-stage solid tumor cancers. Press release.