By Diagnostics World Staff
September 30, 2026 | Oracle and the Buck Institute collaborate on aging research; Mayo Clinic's Precure selects Helix as its multi-omics lab; Revvity launches an IVDR-certified type 1 diabetes screening test; and more.
QIAGEN announced that the FDA has cleared its QIAstat-Dx BCID GN Plus AMR Panel, a test that identifies 13 gram-negative bacterial targets and 18 antibiotic resistance markers from positive blood cultures in about one hour. Together with the previously cleared gram-positive and fungal panel, the clearance completes the company's U.S. QIAstat-Dx bloodstream infection portfolio, which now covers 33 pathogen targets and 28 antimicrobial resistance markers. Bloodstream infections can lead to sepsis, which develops in about 1.7 million U.S. adults each year and contributes to at least 350,000 deaths. The QIAstat-Dx system automates sample preparation, multiplex PCR testing, and data analysis in a single workflow. Press release.
Leica Biosystems completed its acquisition of StatLab Medical Products, a maker of pre-analytical consumables and equipment for pathology labs, from Linden Capital Partners and Audax Private Equity. The deal expands Leica Biosystems' anatomic pathology portfolio to cover the full workflow, from specimen collection through AI-enabled diagnosis. StatLab's consumables and equipment are intended to complement Leica Biosystems' existing instruments and software, helping laboratories reduce process variation and standardize procedures as case volumes rise and staffing remains constrained. The combined organization is positioned to support pathology labs working toward more consistent, scalable diagnostic workflows for cancer patients. No acquisition price was disclosed. The transaction closed September 28, 2026. Press release.
Lund University announced that researcher Sebastian Palmqvist has secured USD 19.4 million (SEK 190 million) from the U.S. National Institutes of Health, through the National Institute on Aging, to develop a clinical blood test for Alzheimer's disease based on the MTBR-tau243 biomarker. The five-year project, running from 2026 to 2031, is a collaboration among Lund University, Washington University in St. Louis, the University of Pennsylvania, and the University of Alabama. While the existing p-tau217 biomarker can detect brain changes years before symptoms appear, MTBR-tau243 reflects the tau tangles that accumulate as symptoms develop. The project aims to produce an FDA-approved test that both identifies Alzheimer's disease and stages its progression. Press release.
QIAGEN announced the launch of QIAmini, a compact automated sample preparation system for research laboratories that process smaller sample batches and do not require larger automated systems. The benchtop instrument, about the size of a sheet of printer paper, processes up to eight samples per run and automates DNA and RNA extraction and purification. Across evaluated workflows, it reduced hands-on time by more than 80%. Five dedicated kits support sample types including tissue, cells, cheek swabs, whole blood, body fluids, and stool, for downstream PCR, digital PCR, and next-generation sequencing. QIAmini is the third sample preparation system QIAGEN has launched in 2026, following QIAsprint Connect and QIAsymphony Connect. Press release.
University of Florida researchers led by virologist John Lednicky and engineer Z. Hugh Fan have developed a low-cost handheld diagnostic device that detects seven mosquito-borne viruses at once: Zika, chikungunya, Mayaro, and four dengue virus types. The device uses RT-LAMP, a method that runs at a single temperature and delivers results in 30 minutes to an hour, compared with one to two days for traditional PCR testing. In validation with human samples, it performed comparably to RT-PCR. The design borrows ballpoint pen mechanics for dispensing liquid, uses a USB-rechargeable coffee mug for temperature control, and reads results with a $12 blue-light flashlight. The researchers are pursuing patents and plan to lower costs further. Press release.
Huntsman Cancer Institute at the University of Utah announced that a research team has received an $8.3 million Research Program Project (P01) grant from the National Cancer Institute to expand access to genetic testing for cancer prevention and care. The five-year program, called 2DETECT, is led by Sean Tavtigian, Guilherme Del Fiol, and Kimberly Kaphingst, with contributions from Wake Forest University and the University of California, Santa Cruz. One project will use AI-based algorithms and electronic health records to identify patients eligible for testing based on family cancer history. A second will evaluate an AI-powered chatbot, offered in English and Spanish, that collects missing family history. A third aims to improve genetic variant classification by incorporating more clinical data. Press release.
Leica Biosystems announced that it has added two Paige digital pathology AI products from Tempus to its Aperio AI Store, a platform that provides multiple AI applications through a single interface. Paige PanCancer Detect is designed to flag suspicious areas across more than 40 cancer types using Tempus' pathology foundation model. Paige Prostate is a suite comprising Paige Prostate Detect, Paige Prostate Grade & Quantify, and Paige Perineural Invasion, which assess prostate cancer features in H&E-stained whole slide images. Both products are for research use only. The Aperio AI Store works with Aperio HALO AP software, allowing researchers to use these applications within one workflow rather than through separate vendor interfaces. Press release.
Babson Diagnostics, maker of BetterWay, announced a three-year research partnership with The University of Texas at Austin to study neurological biomarkers measured from fingertip (capillary) blood samples. Dr. Esther Melamed of Dell Medical School's Department of Neurology will lead the study, which will measure phosphorylated tau 217, neurofilament light chain, and interleukin 6 in patients with Alzheimer's disease, multiple sclerosis, and long COVID, as well as in people without symptoms. The goal is to show that capillary collection can measure these markers accurately while being more comfortable for patients with cognitive impairment, needle anxiety, or difficult-to-access veins. BetterWay has set up a collection site at Dell Medical School and will also enroll participants at its Austin laboratory. Press release.
Revvity announced the launch of the GSP T1D 3plex kit, a fully automated, CE-IVDR-certified test that detects multiple type 1 diabetes autoantibodies at once. The kit is designed for population-wide screening programs to identify children at risk of type 1 diabetes before symptoms appear. It uses capillary dried blood spots for sample collection and runs on Revvity's GSP instrument, a high-throughput platform used in newborn screening. The workflow includes reagents, instrumentation, and software to detect at-risk individuals months or years before symptom onset, allowing for early intervention. The kit will first be available in Europe and in markets that accept CE IVD-marked products; it is not FDA-cleared for use in the U.S. Press release.
Oracle and the Buck Institute for Research on Aging announced a collaboration to study age-related diseases using Oracle Life Sciences Data Intelligence, which holds 122 million de-identified longitudinal health records. The Buck Institute serves as an analytics engine for the Stanford-led THRIVE consortium, part of the Advanced Research Projects Agency for Health (ARPA-H) PROSPR program. The research team will build patient cohorts and apply analytics to decades of health records to find clinical changes that signal frailty or chronic disease years before onset. The work seeks biomarkers for early detection of aging-related complications and will pursue FDA qualification of an Intrinsic Capacity Score, a measure of vitality for healthy aging. Press release.
PhAST Corp. announced that it received FDA 510(k) clearance in June 2026 for its PhAST instrument and Blood Culture Gram-negative Panel. The panel performs phenotypic antimicrobial susceptibility testing directly on positive blood cultures, without the need for subculture, reporting susceptible, intermediate, or resistant results for 15 antimicrobials on single-organism samples containing Acinetobacter species, Enterobacterales, or Pseudomonas aeruginosa. Results take about 100 minutes for Enterobacterales and Acinetobacter and 140 minutes for P. aeruginosa. The platform uses single-cell video microscopy and computer vision, and it showed 97.3% categorical agreement in clinical trials. Each instrument runs four samples at once and handles up to 12 samples per eight-hour shift. Press release.
The University of Birmingham announced IMS Solutions (Intelligent Mass Spec Solutions Ltd), a joint spin-out with Imperial College London that will commercialize steroid diagnostic technology developed at Birmingham. The company uses mass spectrometry and machine learning to detect steroid signatures in urine and blood to diagnose steroid hormone disorders. It closed a £1.1 million seed round led by Midlands Mindforge, and Imperial received a £2.1 million NIHR grant for product development. Its lead urine test, ACCelerate, distinguishes benign adrenal tumors from malignant ones; in a validation study of more than 2,000 patients in 11 countries, it was four times more accurate than scans alone. A UK launch is targeted for 2029, and a blood test for PMOS is in clinical validation. Press release.
RealTime Laboratories launched its Mycotoxin Extensive Panel, a urinary test that measures 31 distinct clinical markers of mycotoxin exposure. The panel covers mycotoxins commonly associated with mold exposure, including satratoxins, roridins, and trichothecenes, and adds 16 markers such as chaetoglobosin A, citrinin, and fumonisins. Testing combines a proprietary hydrolysis processing step with liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. The panel is available both direct-to-consumer and through healthcare provider networks, and it is eligible for HSA and FSA payment. The laboratory also offers EMMA, a separate environmental mold and mycotoxin assessment for testing homes and other environments. Press release.
BD² announced its fourth round of Discovery Research grants, totaling more than $13 million, to study the biological mechanisms behind mood state switching in bipolar disorder. Teams at Harvard Medical School, Johns Hopkins University, and Stanford University will each receive $4.5 million over three years. The Stanford team will examine a rare neuron type in the retrosplenial cortex; the Harvard team will investigate a neural circuit linking the brain's circadian clock to mood and arousal centers; and the Johns Hopkins team will study how potassium and calcium channels interact. BD² also opened a fifth funding round offering up to $5 million per grant for up to four years, focused on women's health and sex differences in bipolar disorder. Press release.
Researchers at the State University of New York have developed a diagnostic method for Meniere's disease that uses mass spectrometry to analyze biochemical markers, including fatty acid profiles, in earwax. The technology is available for licensing through SUNY TechConnect. The method is intended to support earlier detection and disease monitoring. Current diagnosis relies mainly on patient history, subjective symptom reporting, clinical examination, and imaging, which lack the specificity needed to confirm the disease. The non-invasive approach is intended to offer rapid screening, evaluation of treatment response, and improved patient comfort and compliance. The technology is at Technology Readiness Level 4, and a U.S. patent application (18/778,456) is pending. Press release.
Precure, LLC, a company launched by Mayo Clinic and Thermo Fisher Scientific, announced that it has selected Helix as its multi-omic laboratory and artificial intelligence tools provider. Under the partnership, Helix will generate molecular data from about one million biospecimens to help bring precision medicine into routine clinical care at Mayo Clinic and other health systems. Helix will supply AI tools for delivering genomics in clinical settings and for biomarker-driven research, along with population-scale capabilities including clinical whole genome sequencing and research-grade proteome sequencing. The companies selected Ultima Genomics' UG200 Ultra Sequencing Platform, and Helix will deploy a fleet of Ultima systems for whole genome sequencing and proteomics. Press release.
Researchers at the State University of New York have developed AgentHeart, an agentic artificial intelligence platform for cardiac care that is available for licensing through SUNY TechConnect. The platform continuously analyzes patient cardiovascular data and provides clinicians and care teams with real-time, actionable insights. It is designed to be transparent in how it reaches its outputs, tracking cardiovascular trends and flagging emerging risks so care teams can intervene early. The system integrates into existing clinical workflows and is built to work alongside clinicians rather than make decisions independently. Potential applications include cardiology clinics, hospital cardiac units, telemedicine, remote patient monitoring, and clinical research. The technology is at Technology Readiness Level 3, and a patent is pending. Press release.
The Advanced Research Projects Agency for Health (ARPA-H) launched the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program to change how autism is understood, diagnosed, and managed across the lifespan. SPECTRA will combine biological, clinical, behavioral, and real-world data with computational tools to enable earlier diagnosis, identify individual health trajectories, and develop personalized care. The program has four focus areas: analysis of genetic, environmental, and developmental factors; AI-based modeling to map trajectories and identify intervention targets; precision interventions tested in individuals at different life stages; and enabling technologies for accessible communication and assessment. According to the release, one in 31 eight-year-olds in the U.S. has been identified with autism spectrum disorder. Press release.
Brainomix announced that it has been selected for Future Fifty, an invitation-only scale-up programme for UK companies delivered by Tech Nation and Founders Forum Group. Brainomix joins 24 other UK-based companies in the cohort, which spans 10 sectors including artificial intelligence, healthtech, biotech, fintech, energy, and advanced manufacturing. Together, the companies in the cohort have raised £1.47 billion and employ more than 3,800 people. Brainomix, which is headquartered in Oxford with operations in Chicago, develops AI-based imaging software, including Brainomix 360 Stroke and Brainomix 360 e-Lung. The company has received more than 30 regulatory clearances, including from the FDA and under CE marking, and operates in over 20 countries. Press release.
Fuse Diagnostics announced that it has raised £1 million to accelerate commercialization of its Flip product platform and expand manufacturing at its Cambridge, U.K., headquarters. The FSE Group led the funding round, with participation from existing and new angel investors, including Cambridge Capital Group. The Flip platform combines proprietary amplification technology with a low-cost disposable test design to detect pathogens and contaminants without specialist laboratory infrastructure. The company will use the funding to validate its assay development pipeline, scale up manufacturing, and expand commercially across six sectors: life sciences research, bioprocessing, food safety, water quality, veterinary diagnostics, and plant agriculture. Press release.
ProAxsis announced the launch of a new version of its ProteaseTag Active Proteinase 3 Immunoassay (PA008-RUO), a single-use, research-use-only immunoassay for the quantitative measurement of active human proteinase 3 (Pr3). The updated assay has enhanced sensitivity, allowing it to measure lower levels of active Pr3 than previous versions, and is intended for analyzing sputum samples in basic and pharmaceutical research. Pr3 is an enzyme found mainly in neutrophils, and excess Pr3 activity in the lungs can damage airway tissue and cause inflammation. The launch follows an updated ProteaseTag Active Neutrophil Elastase Immunoassay released in 2025, and an updated ProteaseTag Active Cathepsin G Immunoassay is expected by year-end. Press release.
Weill Cornell Medicine announced that it and Rutgers Health in New Brunswick have received a four-year, $3 million grant from the National Institute of Mental Health to establish the New York-New Jersey Center for Actionable NeuroHIV Biomarkers (NYJ-CAN-BIO). The center will provide expertise, training, and technologies to study how HIV affects the brain, with the aim of identifying molecular markers that could enable new diagnostics and therapies for HIV-related neurological complications. Investigators will have access to shared molecular and computational tools, as well as human tissue culture methods including brain organoids. Pilot funding will be available to junior investigators and to investigators new to HIV research at both institutions. Press release.
TÜV SÜD announced a new testing laboratory for Biological Safety, Reusable Device & Lot Release (BRL) services at its Frankfurt site, expanding its testing infrastructure for medical devices. The laboratory, accredited to ISO/IEC 17025, helps manufacturers assess the biological safety of their products, including chemical characterization required under the European Medical Device Regulation (MDR), FDA guidelines, and ISO 10993-18. Its analytical methods include gas chromatography-mass spectrometry (GC-MS) and quadrupole time-of-flight liquid chromatography-mass spectrometry (QTOF-LC/MS). The laboratory complements the company's chemical safety assessment, certification, and market access services. TÜV SÜD planned to present the new BRL services at a Customer Day in Frankfurt on September 16, 2026. Press release.
Yourgene Health, part of the Novacyt Group, announced the commercial launch of its IVDR-certified Yourgene Insight DPYD assay. The launch follows the assay's introduction as a Research Use Only product in May 2026 and completes its transition to compliance with the European Union's In Vitro Diagnostic Regulation. The assay detects 19 clinically relevant variants in the DPYD gene to help identify patients at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy. According to the company, it is the first DPYD test CE-marked under IVDR to include all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology and the NCCN. The assay uses an ARMS allele-specific amplification workflow with ready-to-use reagents and data interpretation tools. Press release.
Ventripoint Diagnostics announced that it has closed the first tranche of a non-brokered private placement of up to $350,000, raising $180,000 through units priced at $0.10. Each unit consists of one common share and one warrant exercisable at $0.14 for 24 months, and the company intends to complete additional tranches. Ventripoint also engaged More Capital Ltd. as strategic growth advisor under a 12-month agreement at $12,500 per month, covering partnerships, market expansion, and technology awareness, and engaged Red Cloud Securities Inc. as market maker at $5,000 per month, subject to TSXV approval. The initiatives support commercialization of VMS+, which provides volumetric cardiac measurements on ultrasound platforms from multiple manufacturers. Press release.
Cepheid announced that it has received Emergency Use Listing (EUL) from the World Health Organization for its Xpert Hemorrhagic Fever Panel test, supporting the diagnostic response to the Ebola Bundibugyo outbreak in the Democratic Republic of the Congo. The test detects nucleic acids of Ebola virus (Zaire, Sudan, Taï Forest, and Bundibugyo species), Crimean-Congo hemorrhagic fever virus, Marburg virus, and Lassa virus, with results in about one hour. It runs on the company's GeneXpert Dx systems, which are deployed across Africa, allowing decentralized testing in affected regions. In June 2026, Cepheid donated an initial shipment of FDA 510(k)-cleared tests to the U.S. Department of Defense for deployment in the DRC. Press release.
VedaBio announced a multi-year partnership with UCP Merchant Medicine (UCPMM) to establish market expectations and performance benchmarks for its amplification-free, CRISPR-based molecular diagnostics platform in urgent care settings. The engagement has two phases. Before the platform's anticipated FDA clearance, the companies will complete five workstreams: a demand forecast for the channel, operator business case and return-on-investment models, a clinic education and training program, pricing references, and introduction of the platform to urgent care leadership. After clearance, UCPMM will support the platform's introduction across its network of 78 health system clients and more than 300 urgent care centers. The platform is designed to deliver syndromic pathogen results from a single swab in under 10 minutes. Press release.