Cytovale recently announced that a large study of its rapid, early IntelliSep sepsis test shows that the rapid host response diagnostic cleared by the Food and Drug Administration reduced the relative rate of sepsis mortality by 39% (Healthcare 2025; doi: 10.3390/healthcare13111273).
It also shows that the test shortened hospital length of stay and enabled more efficient resource allocation in the emergency department, the company said.
The study followed more than 12,000 patients over 1 year at Our Lady of the Lake Regional Medical Center, a 900-bed in-patient acute care facility and Level 1 trauma center in Baton Rouge, Louisiana.
The research reveals unchanged nonsepsis mortality and validates the impact of IntelliSep on targeted triage. Results show a 0.76 day decrease in average hospital length of stay for sepsis patients, with strong implications for improved throughput and cost reduction, as well as a 40% decrease in blood culture usage in low-risk patients and an 8% increase in high-risk cases, the company noted.
Collaboration focuses on companion diagnostics for rare blood cancers
A new global collaboration between Qiagen and Incyte aims to develop a novel diagnostic panel to support Incyte’s portfolio of investigational therapies for patients with myeloproliferative neoplasms (MPNs), the companies recently announced.
MPNs, a group of rare blood cancers comprising about 40% of hematological malignancies, involve chronic accumulation of different mature blood cell types in blood. Incyte’s monoclonal antibody INCA033989, now under development in myelofibrosis and essential thrombocythemia, targets mutant calreticulin, a protein that helps drive this overproduction of blood cells.
Under the agreement, Qiagen will develop a multimodal panel using next-generation sequencing (NGS) technology for detecting clinically relevant gene alterations in hematological malignancies. This panel will serve as a companion diagnostic for INCA033989.
The panel validation will occur via NGS technology and the Illumina NextSeq 550Dx platform as part of Qiagen’s partnership with Illumina to leverage its NGS diagnostic platforms for patient testing. Qiagen will support regulatory submission processes and market access activities across the United States, European Union, and Asia-Pacific regions.
Deal advances high volume testing and technology
Waters Corporation and BD recently announced a definitive agreement to combine BD’s Biosciences & Diagnostic Solutions business with Waters.
The deal joins their complementary technologies to serve high-volume testing in regulated end-markets including liquid chromatography, mass spectrometry, flow cytometry, and diagnostic solutions, Waters and BD said. The deal will lead to new ways to separate large molecules and drive growth in biologics and novel modalities with next-generation consumables, they added.
The transaction allows Waters to systematize instrument replacement, service plan attachment, e-commerce adoption, and new product launches while delivering cost synergies involving manufacturing, supply chain, selling, general, and administrative expenses. Additionally, Waters can maintain its commitment to both research and development and commercial investments, the companies said.
The deal provided an immediate opportunity to apply the company’s expertise to realizing the full potential of its flow cytometry and specialty diagnostics portfolios, Waters officials said.
BD said the deal enhances their company’s strategic focus as a leading medical technology company.
Collaboration to advance saliva-based cancer tests
The University of California, Los Angeles (UCLA) School of Dentistry recently announced a 3-year sponsored research agreement with South Korean semiconductor firm Dongwoon Anatech to develop a noninvasive, saliva-based technology for early detection of oral cancer and other diseases.
The agreement centers UCLA’s Electric Field-Induced Research and Measurement (EFIRM) liquid biopsy platform, which isolates and analyzes biomarker signals directly from body fluids like saliva without complex sample preparation. Prior studies demonstrated EFIRM’s ability to spot tumor-specific mutations, especially for nonsmall cell lung cancer, with high sensitivity and specificity, UCLA said.
The deal involves research that will begin with optimization of various protocols for Dongwoon Anatech’s saliva-based glucose monitoring system, DpSaLife, in patients with and without diabetes, using clinical samples from hospitals in both the United States and South Korea. Later phases will focus on the development and clinical validation of EFIRM I, a fully automated diagnostic device designed to detect salivary biomarkers for cancers such as lung, gastric, and oral cancer.
Partnership to build comprehensive rheumatoid arthritis clinico-genomic dataset
Scipher Medicine and Savant Bio have announced an expanded strategic partnership to build an advanced rheumatoid arthritis (RA) clinico-genomic dataset.
The collaboration aims to transform real-world data from the electronic health records of patients tested with Scipher’s clinically validated molecular signature test, PrismRA, which predicts nonresponse to tumor necrosis factor inhibitor therapies.
The partnership will rely on Savant’s platform, which uses large language models paired with domain-specific quality controls to extract structured variables from free-text clinical documentation, such as physician notes and pathology reports. A variety of information can be linked to claims, labs, and prescribing data for longitudinal analysis. These data will then be converted into structured, analysis-ready formats.
Linking Scipher’s validated genomic insights with structured patient journeys will enable the creation of a foundation for the next generation of real-world evidence and enable faster studies, richer evidence, and more targeted therapies for RA, Savant officials said.
Partnership focuses on home colon cancer RNA screening test
Viome Life Sciences and Scripps Research have established a strategic partnership to develop and clinically validate an RNA test for detecting precancerous colon polyps, the companies recently announced.
The partnership involves an observational study that will analyze RNA data from 1,000 healthy patients who get routine colonoscopies at Scripps Health. Relying on Viome’s RNA sequencing and artificial intelligence platform and Scripps Research’s clinical and translational expertise, the study aims to train Viome’s platform to detect molecular signs of polyp development well before cancer symptoms emerge.
The research involves collecting Viome stool and saliva samples prior to colonoscopies, as well as Viome’s comparative analysis of gene expression profiles and use of its platform to train predictive models to identify early biomarkers. The study also will evaluate sensitivity and specificity.
Read the full September-October issue of CLN here.
