Ultrahuman Launches Glucose Monitoring Health Platform, Automated Cancer Tracking Tool Measures Tumor Dynamics

Clinical whole exome sequencing services identify possible disease-causing genetic changes; a composite biomarker system uses multiple clinically relevant patient features to reflect the heterogeneity of graft failure; a regulatory science tool improves the review processes for stroke rehabilitation devices; and more.

The European Organization for Research and Treatment of Cancer found that liquid biopsies, which are increasingly used in the routine care of patients to identify and monitor cancer progress, can also detect a disorder of blood cells that places patients at higher risk of developing blood cancers. Researchers took liquid biopsies from 1416 patients with a range of solid tumors who had enrolled in the Gustave Roussy Cancer Profiling study. They believe that when liquid biopsies reveal a high-risk clonal hematopoiesis feature—a condition characterized by the hyper-replication of hematopoietic stem cells with the same genetic mutation—this should trigger further hematological evaluation to determine if the patient is at risk for cancer or should receive a diagnosis.

BGI Australia's lab received accreditation from the National Association of Testing Authorities (NATA) to perform clinical whole exome sequencing in Australia, paving the way for the global life sciences company to provide clinical sequencing services for identifying possible disease-causing genetic changes. For the first time after receiving NATA's Human Pathology Laboratory Accreditation, the lab will start to offer clinical services in Australia to clinical labs, hospitals, and other partners to detect changes in the exome that contribute to rare genetic and pediatric diseases.

Jumpcode Genomics introduced an expanded portfolio of RNA depletion technologies to enable researchers to extract greater insights and detect novel signals in the transcriptome that were previously hidden by abundant and uninformative sequences. The CRISPRclean RNA Depletion Portfolio includes several new offerings that harness the specificity of CRISPR to deplete abundant sequences, cut through the noise of uninformative transcripts, and boost discovery. New products include: CRISPRclean High-Expressing RNA Depletion Kit, Focused RNA Depletion Panels, Custom Guide Design, and CRISPRclean Bulk Ribodepletion Reagents. These offerings leverage Jumpcode's patented CRISPR-based technology, which utilizes CRISPR-Cas9 to degrade abundant, uninformative sequences in prepared next-generation sequencing libraries.

The Association for Molecular Pathology published consensus recommendations for using in silico approaches to validate next-generation sequencing (NGS) data analysis pipelines (The Journal of Molecular Diagnostics, DOI: 10.1016/j.jmoldx.2022.09.007). The In Silico Pipeline Validation Working Group offered general recommendations such as the following: the laboratory may use in silico data files to supplement NGS analytical validation but not to supplant the use of physical samples; the laboratory should understand the functional limitations of the type(s) of in silico data utilized; the laboratory may consider using in silico samples for minor updates to clinical bioinformatics software pipelines, and commercial vendors and internal pipeline developers should include options in their analysis pipelines to facilitate easier in silico data file import and analysis by clinical laboratories.

Critical Path Institute's Transplant Therapeutics Consortium received a draft qualification opinion for the iBox Scoring System as a novel secondary efficacy endpoint for kidney transplant trials. This was achieved through the European Medicines Agency's qualification of novel methodologies for drug development. The iBox Scoring System is a composite biomarker that uses multiple clinically relevant patient features to fully reflect the heterogeneity of graft failure, including measures of renal function and immunologic response to the graft, with or without direct assessment of allograft health through histopathology.

Ultrahuman announced the creation of a medical and sports science advisory board which globally renowned medical and med-tech experts will lead. The company is launching clinical trials of its continuous glucose monitoring (CGM) health platform with non-diabetics and pre-diabetics. The clinical trials have been designed in-house with leading global metabolic health experts. This study's metabolic biomarker data will correlate to various CGM parameters. These correlations will be used to construct a scoring system using CGM data to indicate an individual's metabolic health.

Brainomix announced its collaboration with the National Consortium of Intelligent Medical Imaging, hosted at the University of Oxford, and three selected United Kingdom National Health Service (NHS) sites on a project to optimize and validate its automated cancer tracking tool, e-ACT. The device measures lung cancer tumors and detects changes in tumor size, indicating treatment response and disease progression. Preliminary data has already shown that e-ACT is at least as good as specialist doctors in measuring lung cancer tumor size at a single time point. The study team will evaluate how automated assessment of disease progression and treatment response using e-ACT compares to radiologist assessment. The study will also include a descriptive analysis of tumor dynamics using e-ACT in a representative NHS cohort.

Winterlight Labs and Genentech, a member of the Roche Group, have announced new data showing the sensitivity of speech-based digital measures in detecting a disease-related longitudinal change in Alzheimer's disease. Using data from Genentech's Tauriel trial of Semorinemab in early-stage Alzheimer's disease (NCT03289143), these analyses provide new evidence that automated measures for assessing patient speech can characterize longitudinal decline with comparable sensitivity to clinician-administered neuropsychological assessments. Digital efforts can allow for better characterization of speech and language patterns, improved insight into the effects of novel treatments, and support a shift to more hybrid or remote trial designs.

The University of Texas MD Anderson Cancer Center and ARTIDIS AG announced a strategic alliance to investigate ARTIDIS atomic force microscopy technology as a novel treatment-optimization tool for patients with solid tumors in several distinct indications. As part of the research alliance, MD Anderson and ARTIDIS researchers will work together on clinical utility studies to guide signs for the use of the device. In addition, the ARTIDIS team aims to pursue biomarker development avenues that will support the incorporation of ARTIDIS testing into national cancer guidelines and standards of care. MD Anderson clinicians will lead validation and proof-of-concept studies to evaluate the ARTIDIS technology as a tool for predicting response to treatment in multiple solid tumor indications.

SEQSTER PDM and PatientsLikeMe have collaborated to launch one of the first rare-disease studies focused on Alpha-1 Antitrypsin Deficiency (AATD). The study aims to better understand how to reduce diagnosis delays, decrease disparities in care, and improve outcomes in patients with AATD through enhanced digital real-time data, peer support, and real-world evidence. Participants living with AATD can now consent, share, and engage with all of their data in one place, leading to a seamless longitudinal patient journey.

Researchers from the NYU Tandon School of Engineering, the Medical Robotics and Interactive Intelligent Technologies Lab, the NYU School of Medicine, and the U.S. Food and Drug Administration designed a regulatory science tool (RST) based on data from biomarkers to improve the review processes for such stroke rehabilitation devices and how best to use them. This device is the first-ever stroke rehabilitation RST based on exchanges between regions of the central and peripheral nervous systems. Additionally, the project will include seminars and undergraduate research to promote STEM education to engage students from underrepresented groups.