June 24, 2025 | LinusBio announced that ClearStrand-ASD is now available to patients and providers in California, making it available across 48 states in the US; One of the largest real-world studies of a sepsis diagnostic reveals that Cytovale's IntelliSep successfully reduced the relative rate of sepsis mortality by 39%; and more.
Fallouh Healthcare has been awarded a grant of approximately $410,500 from Innovate UK as part of the Eureka Eurostars program to finalize a prototype of PerDeCT, working alongside their Austrian partner the Medizinische Universität Wien, which aims to be the first device for monitoring cardiac function and early diagnosis of cardiac tamponade, a life-threatening complication after heart surgery. PerDeCT is designed to monitor cardiac patients after surgery and provide early diagnosis of tamponade allowing a planned return to surgery to drain fluid and clots around the heart. The award will fund a two-year program to develop a prototype. Press release.
FUJIFILM Healthcare Americas Corporation announced that use of its AFP-L3 and DCP in vitro diagnostic tests is being evaluated in the National Liver Cancer Screening Trial (known as TRACER), a study funded by the National Cancer Institute, part of the National Institute of Health. The multi-center study compares liver cancer screening strategies in patients with cirrhosis or chronic hepatitis B. The use of serum bio markers such as AFP-L3 and des-gamma-carboxyprothrombin (DCP) in surveillance can significantly improve early diagnosis capabilities. Press release.
One of the largest real-world studies of a sepsis diagnostic reveals that Cytovale's IntelliSep, an FDA-cleared rapid host response diagnostic, reduced the relative rate of sepsis mortality by 39%, shortened length of hospital stay, and enabled more efficient resource allocation in the emergency department (ED). The study, "Impact of a Sepsis Quality Improvement Initiative on Clinical and Operational Outcomes," published in the peer-reviewed journal Healthcare, followed more than 12,000 patients over 12 months at Our Lady of the Lake Regional Medical Center (OLOLRMC), a 900-bed in-patient acute care facility and Level 1 trauma center in Baton Rouge, LA. Press release.
Pangaea Data has entered into a collaboration agreement with Alexion, AstraZeneca Rare Disease. This collaboration aims to develop, clinically validate, and obtain regulatory approval for an Artificial Intelligence Clinical Decision Support System (AI-CDSS) designed to improve detection of Hypophosphatasia (HPP) in adults. As part of this collaboration, Alexion will provide funding for the development of the AI-CDSS. By leveraging AI and clinical guidelines, the AI-CDSS will seek to improve the detection of HPP in adults based on information from electronic health records (EHRs). With improved detection, adults living with HPP could receive a timelier diagnosis and clinical intervention. Press release. Pangaea Data has entered into a collaboration agreement with Alexion, AstraZeneca Rare Disease. This collaboration aims to develop, clinically validate, and obtain regulatory approval for an Artificial Intelligence Clinical Decision Support System (AI-CDSS) designed to improve detection of Hypophosphatasia (HPP) in adults. As part of this collaboration, Alexion will provide funding for the development of the AI-CDSS. By leveraging AI and clinical guidelines, the AI-CDSS will seek to improve the detection of HPP in adults based on information from electronic health records (EHRs). With improved detection, adults living with HPP could receive a timelier diagnosis and clinical intervention. Press release.
LEX Diagnostics has submitted dual applications to the FDA seeking 510(k) clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in under ten minutes. The system supports multiplex testing for key respiratory pathogens, including Influenza A, Influenza B, and COVID-19, and is engineered to deliver PCR results in six to ten minutes, easily integrating into clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories, and decentralized acute settings. Press release.
LinusBio announced that ClearStrand-ASD is now available to patients and providers in California, making it available across 48 states in the US. This expansion marks a significant step in LinusBio’s mission to enable earlier identification of autism spectrum disorder (ASD) and support early intervention. ClearStrand-ASD leverages proprietary robotics and lasers to analyze a strand of hair to identify biological and molecular patterns indicative of ASD. The result is an objective, noninvasive screening tool that supports clinical decision-making during a child’s most critical window of development. More information on the platform can be found on Clinical Research News. Press release.
Revvity announced the launch of three Mimix reference standards for IVD use, designed for monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reacting (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for IVD use. These cell line-derived reference standards have undergone appropriate design controls to meet FDA requirements, which helps laboratories integrate them into existing workflows to support monitoring test performance, assay variation, and to help identify increases in random or systemic errors. The three Mimix reference standards cover key cancer testing applications, including the Mimix OncoSpan FFPE Reference Standard IVD (HD832-IVD), Mimix OncoSpan gDNA Reference Standard IVD (HD827-IVD), and Mimix Myeloid Cancer Panel, gDNA Reference Standard IVD (HD829-IVD). Press release.
Labcorp announced the expansion of its precision oncology portfolio. The additions include new test offerings for solid tumor and hematologic malignancies and enhanced biopharma solutions designed to accelerate clinical trials and companion diagnostic development. Some developments include: the availability of new NGS panels for myeloid, lymphoid, and pan-heme indications, expansion of capabilities of OmniSeq INSIGHT, expanded FDA-approved companion diagnostics, and more. Press release.
Danaher launched a partnership with AstraZeneca to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments. This partnership will utilize Danaher Centers for Enabling Precision Medicine to support a more streamlined, end-to-end development process. The first product intended to be developed through this partnership will leverage technologies from Leica Biosystems, one of Danaher's subsidiaries. The initial focus will be on digital and computational pathology products and AI-assisted algorithms to help clinicians better diagnose patients by identifying those who are most likely to benefit from targeted therapies. Press release.
Seer and Korea University announced the launch of a population-level study aimed at identifying novel blood-based biomarkers that could lead to cancer diagnostics for young adults in their 20s and 30s. Using Seer’s newly launched Proteograph ONE Assay and SP200 Automation Instrument along with the Thermo Scientific Orbitrap Astral mass spectrometer, this is the first large-scale plasma proteomics initiative of its kind to leverage mass spectrometry and AI-driven analytics to enhance early cancer detection and improve patient outcomes. Press release.
SAGA Diagnostics announced the US commercial launch of its Pathlight test for the detection of residual disease and recurrence. Pathlight is a first-of-its-kind, multi-cancer MRD platform, initially indicated for early breast cancer, that uses structural variants (SVs) as biomarkers. SVs are well-established hallmarks of cancer, arising from and contributing to genomic instability and oncogenesis. SVs, including breakpoints and rearrangements, are highly tumor- and patient-specific and often reflect the underlying tumor biology making them informative biomarkers for tracking disease. Press release.