April 25, 2024 | Roche will distribute Prenosis’s Sepsis ImmunoScore, an artificial intelligence/machine learning software as a medical device to guide rapid diagnosis of sepsis and prediction of adverse outcomes; PathAI announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology labs accelerate the adoption of AI and digital pathology; more.
Prenosis announced a commercial distribution collaboration with Roche for its Sepsis ImmunoScore, an artificial intelligence/machine learning software as a medical device to guide rapid diagnosis of sepsis and prediction of adverse outcomes. The Sepsis ImmunoScore, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis, will be available on Roche’s navify Algorithm Suite, which offers Roche and third-party evidence-based, certified medical algorithms to customers in one solution platform spanning disease areas. Offering clinicians and lab managers an integrated solution, navify Algorithm Suite aims to transform every stage of care and for confident decision making. Press release.
PathAI announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology (AP) labs accelerate the adoption of AI and digital pathology. The partnership will involve the integration of PathAI’s AISight solution with Google Cloud's infrastructure and AI capabilities, providing accelerated adoption of precision medicine solutions and customized solutions and tailored AI models. Press release.
PacBio announced that the University of Tartu, host of Estonia’s National Biobank, has chosen the Revio HiFi sequencing system to sequence 10,000 whole human genomes and unlock new insights from its populational health data. The announcement follows funding from the European Commission and the Estonian government to help Estonia adopt personalized medicine at scale and adapt public health systems to the biology of its population. The University will also support the European Union’s 1+ Million Genomes initiative, which seeks to boost innovation in healthcare across Europe. Press release.
ReadyGo Diagnostics have announced a strategic manufacturing partnership with Porex. This collaboration marks a significant step toward the commercial availability of ReadyGo's cutting-edge Sampler, designed to revolutionize sample collection and preparation for a wide array of diagnostics including lateral flow, molecular, and biochemical testing. Some key partnership highlights include manufacturing excellence, innovative design, precision and efficiency, and versatile application. Press release.
St George’s, University of London has partnered with Tachmed to accelerate the development of their first in market, affordable diagnostics that are connected digitally for use in the home. Tachmed is a developer of at-home digital healthcare solutions that deliver fast, accurate diagnoses and identify healthcare trends and threats and are currently developing a new diagnostic platform for an array of health conditions using graphene biosensor technology. The partnership will lead to the creation of diagnostic tests that remove the need for patient interpretation of results and can be done in the comfort of their home. The platform will automatically send results straight to the patient’s healthcare practitioner so a diagnosis or treatment plan can be made without the need to wait for a doctor’s appointment, ultimately streamlining access to healthcare. Press release.
Charles River Laboratories International has launched Patholytix Foresight, a non-clinical artificial intelligence decision support tool developed in collaboration with Deciphex. By combining Deciphex’s unique digital pathology solutions with Charles River’s robust non-clinical pathology programs, clients of both organizations will have access to the technology-driven capabilities to accelerate primary evaluation and peer review in toxicologic pathology assessment, enhancing decision-making in drug discovery and safety assessment. Press release.
New England Biolabs has released its Monarch Mag Viral DNA/RNA Extraction Kit. This extraction kit enhances recovery of low amounts of viral nucleic acid to enable highly sensitive detection. The kit uses a magnetic bead-based process to extract viral RNA and DNA reproducibly and efficiently, while enabling scale up for high-throughput automation. The kit is compatible with the most common sample types for extracting viral nucleic acids, including saliva, respiratory swab samples and, following an enrichment step, wastewater samples. Press release.
Nucleai announced a strategic collaboration with GoPath Diagnostics. This collaboration aims to offer AI-powered digital pathology solutions for clinical trials and diagnostics and foster innovative research by combining Nucleai’s expertise in spatial biology and AI with GoPath’s access to multi-modal real-world data, world-class lab services, and cutting-edge molecular capabilities. The integrated solutions will be deployed within a centralized environment that meets the standards of the College of American Pathologists, Clinical Laboratory Improvement Amendments, Clinical Laboratory Evaluation Program, Good Clinical Practice, and Good Clinical Laboratory Practice. This will support clinicians and biopharma partners throughout all stages of oncology and immunology drug development. Press release.
Hartwig Medical Foundation and Ultima Genomics announced the deployment of Ultima’s UG 100 sequencing system and its proprietary ppmSeq technology for improving precision oncology testing and research. This collaboration aims to reduce test costs and make complete genome-based cancer diagnostics accessible for more patients to have better informed cancer treatment. In parallel, platform strengths will be explored for minimal residual disease detection in blood of cancer patients with a one-size-fits-all solution that builds on pre-existing complete tumor profile information. Press release.
Vizgen unveiled the MERSCOPE Ultra Platform and MERFISH 2.0 chemistry. These tools are uniquely suited to supporting basic and translational research and will be commercially available in the second half of the year. The MERSCOPE Ultra is capable of processing 3 cm2 of tissue on a single slide and acquires images at more than double the speed of the MERSCOPE Platform. MERSCOPE Ultra provides researchers with an industry-leading combination of imageable area, speed, and data quality to accelerate discovery and maximize the biology measured from every sample. Further, the system is the only spatial platform to offer two different size flow cells enabling users to adjust reagent consumption based on area imaged. Press release.
Culmination Bio announced a partnership with BillionToOne to work together to leverage their respective strengths in order to facilitate the development and validation of robust and impactful oncology diagnostics. This collaboration comprises two separate projects, each highly valuable to advancing the development of these diagnostics and making it possible for future regulatory submissions. This news comes on the heels of Culmination Bio’s $10 million investment from Merck Global Health Innovation Fund and Amgen Ventures, along with the recent announcement of the company’s multi-year R&D partnership with Merck to study autoimmune diseases. Press release.
PreciseDx announced a sponsored research collaboration with UCLA's Department of Pathology and Laboratory Medicine in Los Angeles to evaluate PreciseBreast's ability to accurately assess risk of recurrence for patients with triple-negative breast cancer (TNBC). TNBC constitutes only 10-20% of all breast cancer cases yet continues to demand significant clinical interest due to its limited response to conventional treatments, the association with younger women, BRCA1/2 mutations, ethnic/racial disparities, and its highly aggressive characteristics. The current study will expand on the previous subgroup analysis of TNBC patients from the PreciseBreast-Mount Sinai Hospital, NY, validation study with a large, well-annotated outcome-based TNBC cohort from the UCLA Health System. Press release.
Bio-Rad Laboratories announced the launch of its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay expands the company’s Droplet Digital PCR offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring. The ddPLEX ESR1 Mutation Detection Kit enables simultaneous detection, discrimination, and absolute quantification of seven known relevant ESR1 mutations, in a single well, with an analytical sensitivity down to 0.01% variant allele fraction. The kit includes controls and enables same-day results from either circulating tumor DNA from plasma or DNA from formalin-fixed paraffin-embedded tissue samples. Press release.
Twist Bioscience has launched a new Human Pangenome Spike-in for the Twist Exome 2.0 panel developed to enable researchers to detect a more complete view of genetic variation during whole exome sequencing. The Human Pangenome Reference Consortium (HPRC) is a project funded by the National Human Genome Research Institute that has the objective to sequence and assemble complete telomere-to-telomere genomes from individuals from diverse populations into a new type of reference in order to better represent the genomic landscape of diverse human populations. The updated HPRC reference standard includes samples from 24% African ancestry, 30% Americas, 18% East Asia, and 28% South Asia. Press release.
QIAGEN announced the release of the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade, an enhancement to the widely-used QIAstat-Dx Analyzer 1.0 for reliable, fast, and cost-effective diagnosis of complex syndromes. The upgraded diagnostic system introduces the Remote Results Application, which allows users to view, comment, and confirm diagnostic test results directly from their desktop and mobile devices in any location, facilitating collaboration across the healthcare system. This enables greater flexibility and collaboration between central and regional labs, especially in decentralized testing, reducing diagnostic processing time, and ensuring patients receive accurate results more quickly. Press release.