By Diagnostic World Team
January 28, 2024 | PathAI and Discovery Life Sciences launch partnership; new diagnostic tools for epilepsy, syphilis; OGT launches MRD panel; more.
23andMe Holding Co. has launched Discover23, a new research offering enabling authorized collaborators to securely access the power and diversity of the 23andMe research cohort through a Trusted Research Environment (TRE) developed by Lifebit. Discover23 provides analysis-ready genome-wide association studies (GWAS) conducted on 1000+ disease and condition cohorts curated from 4.7B phenotypic data points by 23andMe’s expert scientists. Biopharma collaborators will be able to access summarized results of analyses conducted using data stripped of personal identifiers within 23andMe’s TRE, where authorized researchers are provided with highly secure, isolated workspaces to leverage 23andMe research findings while ensuring the protection of participant privacy. Press release.
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity Test System, a first-in-class molecular test from Inflammatix for patients with suspected acute infection or sepsis. Using precise measurements of a patient's immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient's status. The TriVerity rapid blood test measures the expression levels of 29 genes associated with the host immune response to infection. The test uses validated algorithms developed applying artificial intelligence (AI)/machine learning to interpret the host response information into three scores that indicate the likelihood of (1) bacterial infection, (2) viral infection, and (3) severe illness (as defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days). TriVerity is expected to ease the burden faced by hospital systems, which are plagued by emergency department overcrowding, and, for those patients admitted, with lengths of stay commonly measured not in hours but in days or even weeks. Press release.
PathAI has announced a strategic partnership with Discovery Life Sciences, a leading biospecimens and specialty lab testing company, to offer Discovery’s customers enhanced, AI-enabled digital and quantitative insights from biospecimens to better inform drug and diagnostic development. This collaboration marks a milestone as the first at-scale deployment of AI technologies into a leading commercial biobank. Through this partnership, Discovery will deploy PathAI’s AISight Image Management System (IMS), ArtifactDetect, and TumorDetect products globally across its biospecimens business. In doing so, Discovery will help transform their traditional pathology workflow, significantly saving pathologists' time by automating routine tasks and analysis and allowing pathologists to focus on more complex tasks. Discovery will also empower customers with additional quantitative, tissue-level insights to provide more confident and standardized structured data from their biospecimens. Press release.
A new tool from Johns Hopkins University researchers could reduce epilepsy misdiagnoses by up to 70%. EpiScalp turns routine electroencephalogram, or EEG, tests that appear normal into highly accurate epilepsy predictors. By uncovering hidden epilepsy signatures in seemingly normal EEGs, EpiScalp could significantly reduce false positives—seen in around 30% of cases globally—and spare patients from medication side effects, driving restrictions, and other quality-of-life challenges linked to misdiagnoses. The study analyzed 198 epilepsy patients from five major medical centers. Out of these 198 patients in the study, 91 patients had epilepsy while the rest had non-epileptic conditions mimicking epilepsy. When the initial EEGs were reanalyzed using EpiScalp, the tool ruled out 96% of those false positives, cutting potential misdiagnoses among these cases from 54% to 17%. Annals of Neurology
OGT has announced the North American launch of its new next-generation sequencing (NGS) SureSeq Myeloid MRD Panel, which provides a flexible NGS workflow for the detection of ultra-low frequency measurable residual disease (MRD)-associated biomarkers in acute myeloid leukemia (AML). This ultra-sensitive NGS panel leverages OGT’s expertise in hybrid capture to enhance the detection of the largest and most complex AML associated variants in key genes, such as large FLT3-ITDs, that often go undetected by previous generations of PCR-based enrichment technologies. The ultra-sensitive detection of MRD in AML is a critical tool for advancing clinical research in AML. NGS-based AML MRD is being more widely adopted in drug development and studies aiming to improve clinical management of AML. Clinical research studies into MRD continue to drive deeper understanding of AML remission and relapse, including evidence highlighting that MRD negativity is associated with a better 5-year survival rate compared to MRD positive defined samples.1 Being able to sensitively detect even a few residual leukemic cells provides a more comprehensive picture of the current AML status of a sample. Press release.
NOWDiagnostics’ First To Know Syphilis Test has joined the innovative TakeMeHome initiative. In collaboration with NASTAD (National Alliance of State and Territorial AIDS Directors) and Building Healthy Online Communities (BHOC), this partnership addresses the growing syphilis epidemic by expanding access to in-home testing and empowering individuals with discreet, accurate and private solutions. Eligible consumers can now order a free First To Know Syphilis Test from the TakeMeHome initiative and have it delivered discreetly to their home. The First To Know Syphilis Test is the first FDA-marketing-authorized OTC blood test for syphilis, offering laboratory-quality results in just minutes. As part of the TakeMeHome program, this diagnostic tool helps overcome critical barriers to syphilis testing, including stigma, limited access to healthcare and privacy concerns. Press release.
Diaceutics and Cornerstone AI have launcheda strategic partnership to enhance the accuracy, completeness and usability of data from the DXRX laboratory network. The collaboration integrates Cornerstone AI's proprietary lab data algorithms with Diaceutics' real-world data ecosystem, generating LOINC assignments to deliver faster, more accurate, and clinically meaningful insights. Laboratory data, often disjointed and inconsistent, remains a major hurdle in implementing precision medicine initiatives. By combining Cornerstone AI's advanced data quality and enhancement technology with Diaceutics' expertise in real-world data, the partnership addresses this challenge head-on improving overall data integrity. These advancements offer pharmaceutical, biotech, and diagnostics companies a stronger foundation for clinical development, faster market access, and better patient outcomes—delivering significant value across the healthcare ecosystem. Press release.
Revvity has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders. The state-of-the-art assay is processed on the Company’s random-access iSYSTM or i10 TM instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining superior accuracy and reliability. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes. Press release.
SandboxAQ and Mayo Clinic are collaborating to explore the combined use of electrocardiography (ECG) and magnetocardiography (MCG) technologies for characterizing disease progression and treatment response in patients with amyloidosis. This collaboration underscores a shared commitment to use quantitative AI and the latest in sensing technology to significantly improve cardiac diagnostics. By integrating the time-tested reliability of ECG with the cutting-edge sensitivity of MCG, this collaboration aims to explore and create a novel, complementary, and non-invasive diagnostic solution that provides deeper insights into the electrical and magnetic activity of the heart. This dual-modality technique could enable the detection of functional changes in amyloidosis and offer a better method for tracking disease progression & treatment response over time. Press release. SandboxAQ also just announced a partnership with Google Cloud to integrate and optimize its platform of Large Quantitative Models (LQMs) on Google Cloud. Press release.
Sapient has partnered with Alamar Biosciences to extend its targeted proteomics services to include high-sensitivity cytokine, chemokine, and neuroinflammatory mediator multiplex and single-plex assays using Alamar’s NULISA platform and ARGO HT system. Sapient will be an Alamar-certified service provider for the NULISAseq Inflammation Panel profiling 250+ cytokine and chemokine biomarkers and the NULISAseq CNS Disease Panel profiling 120+ low-abundance neurodegeneration and neuroinflammatory biomarkers, as well as for custom development of precision proteomics assays using Alamar’s technologies. Sapient will additionally be working closely with Alamar to offer NULISAseq assays under regulated guidance, including CAP/CLIA and GCLP. Press release.
Revvity announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, co-developed with Element Biosciences. This initiative builds upon Revvity's recent introduction of an automated next-generation sequencing (NGS) workflow for newborn sequencing research and strengthens Element’s momentum towards regulatory approval of the benchtop AVITI sequencing system. The collaboration involves the co-development of a comprehensive IVD solution tailored for newborn sequencing. Additionally, customers will have immediate access to a research use only (RUO) version of the newborn sequencing research workflow. Press release.
The University of Texas MD Anderson Cancer Center and Myriad Genetics announced a five-year strategic alliance to evaluate the clinical validity and utility of Myriad’s Precise MRD assay. Under the terms of the agreement, MD Anderson and Myriad Genetics will collaborate to design both retrospective and prospective studies to investigate the test’s utility in breast, gastrointestinal, genitourinary, and gynecological cancers. The goal of these studies is to generate evidence that supports national guideline inclusion and healthcare provider adoption. Press release.